a gynecologic oncologist’s approach to general gynecology ... · a gynecologic oncologist ......

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AAGLAdvancing Minimally Invasive Gynecology Worldwide

A Gynecologic Oncologist’s Approach to

General Gynecology: Tackling Complex

Benign Surgeries with Ease (Didactic)

PROGRAM CHAIR

Michael F. Frumovitz, MD

David M. Boruta, MDAmanda Nickles Fader, MD

Jubilee Brown, MDJavier F. Magrina, MD

Pedro T. Ramirez

Pedro F. Escobar, MDR. Wendell Naumann, MD

Professional Education Information Target Audience Educational activities are developed to meet the needs of surgical gynecologists in practice and in training, as well as, other allied healthcare professionals in the field of gynecology. Accreditation AAGL is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AAGL designates this live activity for a maximum of 3.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity. DISCLOSURE OF RELEVANT FINANCIAL RELATIONSHIPS As a provider accredited by the Accreditation Council for Continuing Medical Education, AAGL must ensure balance, independence, and objectivity in all CME activities to promote improvements in health care and not proprietary interests of a commercial interest. The provider controls all decisions related to identification of CME needs, determination of educational objectives, selection and presentation of content, selection of all persons and organizations that will be in a position to control the content, selection of educational methods, and evaluation of the activity. Course chairs, planning committee members, presenters, authors, moderators, panel members, and others in a position to control the content of this activity are required to disclose relevant financial relationships with commercial interests related to the subject matter of this educational activity. Learners are able to assess the potential for commercial bias in information when complete disclosure, resolution of conflicts of interest, and acknowledgment of commercial support are provided prior to the activity. Informed learners are the final safeguards in assuring that a CME activity is independent from commercial support. We believe this mechanism contributes to the transparency and accountability of CME.

Table of Contents

Course Description ........................................................................................................................................ 1 Disclosure ...................................................................................................................................................... 3 Pelvic Anatomy for the General Gynecologist J.F. Magrina .................................................................................................................................................. 5 Identification and Safe Laparoscopic Dissection of the Ureter M. Frumovitz ................................................................................................................................................ 7 Prevention and Management of Surgical Bleeding P.T. Ramirez ............................................................................................................................................... 12 Management of Bladder and Bowel Injuries A. Nickles Fader .......................................................................................................................................... 18 Work‐up of Adnexal Masses – CA125, HE4, OVA1 or None of the Above? P.F. Escobar ................................................................................................................................................ 25 Adnexal Masses and Pregnancy J. Brown ...................................................................................................................................................... 34 A Gynecologic Oncologists Approach to Removing Difficult Adnexal Masses D.M. Boruta ................................................................................................................................................ 38 A Gynecologic Oncologist’s Approach to Endometriosis R.W. Naumann ........................................................................................................................................... 42 Cultural and Linguistics Competency ......................................................................................................... 47

PG 215 A Gynecologic Oncologist’s Approach to General Gynecology:

Tackling Complex Benign Surgeries with Ease (Didactic)

Michael F. Frumovitz, Chair

Faculty: David M. Boruta, Jubilee Brown, Pedro F. Escobar, Amanda Nickles Fader, Javier F. Magrina, R. Wendell Naumann, Pedro T. Ramirez

Course Description This course provides the general gynecologist with the tips and tricks that gynecologic oncologists use to safely perform complex minimally invasive surgery. Using didactics and videos, the course will first provide a comprehensive review of the pelvic anatomy followed by surgical techniques to avoid complications. As we all encounter surgical morbidity, attendees will learn how to manage vascular, bowel, and urologic injuries and when to call for assistance. In the second half of the course, we will start by reviewing the latest literature on the radiologic and hematologic work-up of pelvic masses in both pregnant and non-pregnant women. Then, following the anatomic landmarks learned in the first portion of the course, the audience will see the surgical approaches to safely performing surgery for difficult benign processes such as benign ovarian masses and endometriosis.

Course Objectives At the conclusion of this course, the participant will be able to: 1) Dissect in the retroperitoneal space; 2) anticipate and avoid bleeding, bowel and ureteral complications; 3) manage complications associated with pelvic surgery; 4) perform appropriate preoperative evaluation of adnexal masses in pregnant and non-pregnant women; and 5) use the learning process to understand the surgical principles to performing complex benign surgery safely.

Course Outline 1:30 Welcome, Introductions and Course Overview M. Frumovitz 1:35 Pelvic Anatomy for the General Gynecologist J.F. Magrina 2:00 Identification and Safe Laparoscopic Dissection of the Ureter M. Frumovitz 2:25 Prevention and Management of Surgical Bleeding P.T. Ramirez 2:50 Management of Bladder and Bowel Injuries A. Nickles Fader 3:15 Questions & Answers All Faculty 3:25 Break 3:40 Work-up of Adnexal Masses – CA125, HE4, OVA1 or None of the Above? P.F. Escobar

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4:05 Adnexal Masses and Pregnancy J. Brown 4:30 A Gynecologic Oncologists Approach to Removing Difficult Adnexal Masses D.M. Boruta 4:55 A Gynecologic Oncologist’s Approach to Endometriosis R.W. Naumann 5:20 Questions & Answers All Faculty 5:30 Course Evaluation

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PLANNER DISCLOSURE The following members of AAGL have been involved in the educational planning of this workshop and have no conflict of interest to disclose (in alphabetical order by last name). Art Arellano, Professional Education Manager, AAGL* Viviane F. Connor Consultant: Conceptus Incorporated Frank D. Loffer, Executive Vice President/Medical Director, AAGL* Linda Michels, Executive Director, AAGL* Jonathan Solnik Other: Lecturer - Olympus, Lecturer - Karl Storz Endoscopy-America SCIENTIFIC PROGRAM COMMITTEE Arnold P. Advincula Consultant: CooperSurgical, Ethicon Women's Health & Urology, Intuitve Surgical Other: Royalties - CooperSurgical Linda Bradley Grants/Research Support: Elsevier Consultant: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharmaceuticals Speaker's Bureau: Bayer Healthcare Corp., Conceptus Incorporated, Ferring Pharm Keith Isaacson Consultant: Karl Storz Endoscopy Rosanne M. Kho Other: Honorarium - Ethicon Endo-Surgery C.Y. Liu* Javier Magrina* Ceana H. Nezhat Consultant: Intuitve Surgical, Lumenis, Karl Storz Endoscopy-America Speaker's Bureau: Conceptus Incorporated, Ethicon Women's Health & Urology William H. Parker Grants/Research Support: Ethicon Women's Health & Urology Consultant: Ethicon Women's Health & Urology Craig J. Sobolewski Consultant: Covidien, CareFusion, TransEnterix Stock Shareholder: TransEnterix Speaker's Bureau: Covidien, Abbott Laboratories Other: Proctor - Intuitve Surgical FACULTY DISCLOSURE The following have agreed to provide verbal disclosure of their relationships prior to their presentations. They have also agreed to support their presentations and clinical recommendations with the “best available evidence” from medical literature (in alphabetical order by last name). Michael F. Frumovitz* David M. Boruta Consultant: Boston Scientific Corp. Inc. Jubilee Brown* Pedro F. Escobar* Amanda Nickles Fader*

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Javier F. Magrina* R. Wendel Naumann* Pedro T. Ramirez* Asterisk (*) denotes no financial relationships to disclose.

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Pelvic Anatomy for the generalist

Javier Magrina, MD

Mayo Clinic Arizona

Disclosure

I have no financial relationships to disclose.

Objective

Review retroperitoneal anatomy

Spaces

Vessels

Identify your enemies

• External and common iliac arteries

• Obturator nerve

• Lumbosacral trunk

• Ureters

Internal iliac artery branching

• 9 different types

• 49 different subtypes

Hypogastric artery branching

“…the manner of branching departs so frequently from the so‐called standard pattern that it is usually impossible to identify the various vessels without following them for some distance to ascertain their course and destinations”

Ashley FL, Anson BJ. Am J Phys Anthropol 28:381, 1941

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Most common aberrant branch of internal

iliac artery:iliac artery:

Obturator artery

Ashley FL, Anson BJ. Am J Phys Anthropol 28:381, 1941

Practical Internal iliac branching

• Anterior: superior vesical, uterine

• Lateral: int. pudendal, inferior glutealp , g

• Posterior: superior gluteal

Posterior branch of internal iliac art.

• Distance from common iliac bifurcation: 2.7 cm

• Diameter: 5 mm

Most common: one single vessel (65%) giving

iliolumbar

lumbosacral

and ending in superior gluteal artery*

*first branch 3%

• Ashley FL, Anson BJ. Am J Phys Anthropol 28:381, 1941

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Identification and Safe Dissection of the UreterIdentification and Safe

Dissection of the Ureter

MichaelMichael FrumovitzFrumovitz MD MPHMD MPHMichaelMichael FrumovitzFrumovitz MD MPHMD MPHMichael Michael FrumovitzFrumovitz, MD, MPH, MD, MPH

Associate Professor and Fellowship DirectorAssociate Professor and Fellowship Director

Gynecologic OncologyGynecologic Oncology

Michael Michael FrumovitzFrumovitz, MD, MPH, MD, MPH

Associate Professor and Fellowship DirectorAssociate Professor and Fellowship Director

Gynecologic OncologyGynecologic Oncology

DisclosureDisclosure

I have no financial relationships to disclose.I have no financial relationships to disclose.I have no financial relationships to disclose.I have no financial relationships to disclose.

Ureteral InjuryUreteral Injury

•• 0.4% to 2.5% of benign pelvic surgeries0.4% to 2.5% of benign pelvic surgeries

•• As high as 5% in radical hysterectomy As high as 5% in radical hysterectomy

•• Only oneOnly one third recognized at time ofthird recognized at time of

•• 0.4% to 2.5% of benign pelvic surgeries0.4% to 2.5% of benign pelvic surgeries

•• As high as 5% in radical hysterectomy As high as 5% in radical hysterectomy

•• Only oneOnly one third recognized at time ofthird recognized at time of•• Only oneOnly one--third recognized at time of third recognized at time of surgerysurgery

•• Only oneOnly one--third recognized at time of third recognized at time of surgerysurgery

Bladder/Ureteral InjuryBladder/Ureteral Injury

Lim Lim et alet al. 2010. 2010

Risk FactorsRisk Factors

Most CommonMost Common•• Heavy bleedingHeavy bleeding

•• EndometriosisEndometriosis

Most CommonMost Common•• Heavy bleedingHeavy bleeding

•• EndometriosisEndometriosis

Less commonLess common•• Congenital anomaliesCongenital anomalies

–– Ureter duplicationUreter duplication

E t i kidE t i kid

Less commonLess common•• Congenital anomaliesCongenital anomalies

–– Ureter duplicationUreter duplication

E t i kidE t i kid•• Large ovarian massesLarge ovarian masses

•• PIDPID

•• Previous pelvic surgeryPrevious pelvic surgery

•• Broad ligament fibroidsBroad ligament fibroids

•• Previous pelvic irradiationPrevious pelvic irradiation

•• Large ovarian massesLarge ovarian masses

•• PIDPID

•• Previous pelvic surgeryPrevious pelvic surgery

•• Broad ligament fibroidsBroad ligament fibroids

•• Previous pelvic irradiationPrevious pelvic irradiation

–– Ectopic kidneyEctopic kidney

–– MegaureterMegaureter

–– Ectopic kidneyEctopic kidney

–– MegaureterMegaureter

The Best Offense is a Good Defense

The Best Offense is a Good Defense

KNOW THE ANATOMY!!!KNOW THE ANATOMY!!!KNOW THE ANATOMY!!!KNOW THE ANATOMY!!!

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VIDEOVIDEO

Tips for Preventing GU InjuriesTips for Preventing GU Injuries

•• Know anatomyKnow anatomy

•• Use visual landmarksUse visual landmarks

•• Restore normal anatomyRestore normal anatomy

•• Know anatomyKnow anatomy

•• Use visual landmarksUse visual landmarks

•• Restore normal anatomyRestore normal anatomy•• Restore normal anatomyRestore normal anatomy

•• Trace path of ureter through pelvisTrace path of ureter through pelvis

•• PreopPreop stenting/IVP limited valuestenting/IVP limited value

•• CystoscopeCystoscope every TLH?every TLH?

•• Restore normal anatomyRestore normal anatomy

•• Trace path of ureter through pelvisTrace path of ureter through pelvis

•• PreopPreop stenting/IVP limited valuestenting/IVP limited value

•• CystoscopeCystoscope every TLH?every TLH?

VIDEOVIDEO

VIDEOVIDEO

Repair of CystotomyRepair of Cystotomy

• Identify ureteral orifices bilaterally – Consider stents and Urology if the trigone is involved

• Close in two layers with a non-permanent suture

• Identify ureteral orifices bilaterally – Consider stents and Urology if the trigone is involved

• Close in two layers with a non-permanent suture– First layer: Closely spaced interrupted sutures

• Mucosa + muscularis

– Second layer: Imbricate with continuous or interrupted

• Serosa and muscularis

• Foley for 10-14 days

– First layer: Closely spaced interrupted sutures• Mucosa + muscularis

– Second layer: Imbricate with continuous or interrupted

• Serosa and muscularis

• Foley for 10-14 days

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Chan et al, Am J Obstet Gynecol, 2003

Types of Ureteral InjuriesTypes of Ureteral Injuries

•• PuncturePuncture•• Ligation/ClippedLigation/Clipped•• Angulation/TetheringAngulation/Tethering

•• PuncturePuncture•• Ligation/ClippedLigation/Clipped•• Angulation/TetheringAngulation/Tethering•• CrushCrush•• ThermalThermal•• LacerationLaceration•• TransectionTransection•• IschemiaIschemia•• ResectionResection

•• CrushCrush•• ThermalThermal•• LacerationLaceration•• TransectionTransection•• IschemiaIschemia•• ResectionResection

VIDEOVIDEOJMIG, 2012

•• “At this time, the AAGL Practice “At this time, the AAGL Practice •• “At this time, the AAGL Practice “At this time, the AAGL Practice Committee recommends that surgeons Committee recommends that surgeons and institutions consider routine and institutions consider routine implementation of cystoscopy at the time implementation of cystoscopy at the time of laparoscopic total hysterectomy.”of laparoscopic total hysterectomy.”

Committee recommends that surgeons Committee recommends that surgeons and institutions consider routine and institutions consider routine implementation of cystoscopy at the time implementation of cystoscopy at the time of laparoscopic total hysterectomy.”of laparoscopic total hysterectomy.”

Bladder/Ureteral InjuryBladder/Ureteral Injury

JelovsekJelovsek et alet al. 2007. 2007

Chan et al, Am J Obstet Gynecol, 2003

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Principles of Ureteral RepairPrinciples of Ureteral Repair

1.1. Meticulous dissection preserving adventitiaMeticulous dissection preserving adventitia

2.2. Tension freeTension free

3.3. Watertight closure with absorbable sutureWatertight closure with absorbable suture

1.1. Meticulous dissection preserving adventitiaMeticulous dissection preserving adventitia

2.2. Tension freeTension free

3.3. Watertight closure with absorbable sutureWatertight closure with absorbable suture

4.4. Protect with peritoneum or omentumProtect with peritoneum or omentum

5.5. Drain with closed bulb suctionDrain with closed bulb suction

6.6. Stent ureterStent ureter

7.7. Consider proximal diversionConsider proximal diversion

4.4. Protect with peritoneum or omentumProtect with peritoneum or omentum

5.5. Drain with closed bulb suctionDrain with closed bulb suction

6.6. Stent ureterStent ureter

7.7. Consider proximal diversionConsider proximal diversion

UreteroneocystostomyUreteroneocystostomy

•• Ligate distal ureteral stumpLigate distal ureteral stump

•• Mobilize bladder and ureterMobilize bladder and ureter

•• Open bladderOpen bladder

•• SpatulateSpatulate ureterureter

•• Ligate distal ureteral stumpLigate distal ureteral stump

•• Mobilize bladder and ureterMobilize bladder and ureter

•• Open bladderOpen bladder

•• SpatulateSpatulate ureterureter•• SpatulateSpatulate ureterureter

•• Implant into bladderImplant into bladder

•• Reinforce/protectReinforce/protect

•• Stent ureterStent ureter

•• Suction drainSuction drain

•• SpatulateSpatulate ureterureter

•• Implant into bladderImplant into bladder

•• Reinforce/protectReinforce/protect

•• Stent ureterStent ureter

•• Suction drainSuction drain

Utrie JW. Clin Obstet Gynecol, 1998

Psoas HitchPsoas Hitch

•• Close bladder Close bladder verticallyvertically

S tS t

•• Close bladder Close bladder verticallyvertically

S tS t•• Secure to psoas Secure to psoas tendontendon

•• Be mindful of Be mindful of genitofemoralgenitofemoral

•• Secure to psoas Secure to psoas tendontendon

•• Be mindful of Be mindful of genitofemoralgenitofemoral

Mendez L, Surg Clin North Am, 2001

Boari FlapBoari Flap

•• Oblique flap with wide Oblique flap with wide basebase

•• Oblique flap with wide Oblique flap with wide basebasebasebase

•• Preserve blood supplyPreserve blood supply

•• TubularizeTubularize flapflap

basebase

•• Preserve blood supplyPreserve blood supply

•• TubularizeTubularize flapflap


UreteroureterotomyUreteroureterotomy

•• MobilizeMobilize

•• Dissect nonviable Dissect nonviable titi

•• MobilizeMobilize

•• Dissect nonviable Dissect nonviable tititissuetissue

•• Reanastomose over Reanastomose over stentstent

•• Maintain vascularityMaintain vascularity

•• Protect with omentumProtect with omentum

tissuetissue

•• Reanastomose over Reanastomose over stentstent

•• Maintain vascularityMaintain vascularity

•• Protect with omentumProtect with omentum


UreteroileocystostomyUreteroileocystostomy

•• Isolate healthy ileumIsolate healthy ileum

•• EndEnd--toto--side side ureteroileostomyureteroileostomy

•• Isolate healthy ileumIsolate healthy ileum

•• EndEnd--toto--side side ureteroileostomyureteroileostomyureteroileostomyureteroileostomy

•• Anastomose end of Anastomose end of ileum to dome of ileum to dome of bladderbladder

•• Suction drain Suction drain essentialessential

ureteroileostomyureteroileostomy

•• Anastomose end of Anastomose end of ileum to dome of ileum to dome of bladderbladder

•• Suction drain Suction drain essentialessential


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Thank You!Thank You!

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Vascular ComplicationsTools for Prevention & Management

Pedro T. Ramirez, M.D.

Professor

Director of Minimally Invasive Research & Education

Department of Gynecologic Oncology & Reproductive MedicineDepartment of Gynecologic Oncology & Reproductive MedicineNo Financial Disclosures

Objectives

• Incidence of vascular injuries

• Risk factors

• Etiology

• Prevention

• Anatomy

• Management

N=713 (1985‐2002)

Etiology:gy

Blunt (non‐iatrogenic) 178 (25%)

Catheter (iatrogenic) 367 (52%)

Operative (iatrogenic) 166 (23%)

• Overall outcomes

‐Perioperative mortality 18%

Multi‐system organ failureMulti system organ failure

Exanguinating hemorrhage

Thromboembolic events

‐All deaths secondary to venous injury

‐Mean length of stay 41 days (2‐280)

Anterior Abdominal Wall

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Superior Epigastric Arteries

Inferior Epigastric Arteries

Superficial Epigastric Arteries

Umbilicus

Umbilicus Relative to Weight

Caution in Trendelenburg

Avoid Poor Technique

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N=3

EBL (100‐2,000 cc)

Etiology: Arching current

Laceration of protective sheath

Pelvic Vascular Injury

• Treacherous

• Low pressure high flow system

• Difficult access

• Multiple thin walled plexuses

A i t d• Associated organs

• Hostile operative field

– Oncology

– Re‐do operation

– Radiation

Initial Hemorrhage Control

DON’TPANIC

Management Vascular InjuriesLaparoscopy vs. Laparotomy

• What’s your skill level!?

• Immediate conversion

d• Adequate exposure

• Direct vascular compression

• Role of anesthesia

• Vascular surgeon

• Goal: STOP blood loss

• Manual compression

• Avoid surgical clamps:


– Frequently ineffective

– Damage surrounding structures

– Partial injury complete transection

– Injury to vessel wall

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• Ensure adequate exposure– Lengthen incision

– Conversion to open‐Midline incision!!

– Obtain additional retraction aids


– Multiple suction devices

• Communicate with anesthesiologist– Volume / blood products (warmed)

– Adequate intravenous access


• Obtain proximal and distal control

‐Rummel tourniquets

• Avoid entering hematoma

• Encircle aorta & common iliac• Encircle aorta & common iliac

• Mobilization of distal cava

• Medial visceral rotation

Exposure and Control Exposure and Control

Mobilization of Iliac Vessels Simple Vascular Repair

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Simple Vascular Repair Simple Vascular Repair

•• LumenalLumenal narrowingnarrowing

Patch Angioplasty End‐to‐End Repair

Interposition Graft Fogarty Balloon Catheter

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Conclusions

• Vascular injuries are rare but lethal

• Be smart‐ AVOID the injury

• Know your skill level!!

Ai f t ti t l f bl di• Aim for atraumatic control of bleeding

• Prompt Vascular Surgery consultation

• Most patients can be salvaged

• DON’T PANIC!!!

MD Anderson Cancer CenterEmail: [email protected]

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Laparoscopic Management of Bladder and Bowel Injuries

Amanda Amanda NicklesNickles Fader, MDFader, MDAssistant Professor, Gynecologic OncologyAssistant Professor, Gynecologic Oncology

Johns Hopkins Medical InstitutionsJohns Hopkins Medical Institutions

DisclosuresDisclosures


ObjectivesObjectives

Review incidence of laparoscopic bowel and bladder injuries in gynecologic surgery

Discuss patient safety, positioning and entry t h i t t i l i jtechniques to prevent visceral injury

Demonstrate tips and tricks for laparoscopic repair of bowel and bladder injuries

Laparoscopy and Complications Laparoscopy affords a safe and less invasive modality for

performance of both diagnostic and major operative procedures

As surgeons expand their laparoscopic skills and increase d h d b d h f l l i ddepth and breadth of complex laparoscopic procedures offered to their patients, important to become familiar with the potential complications that may arise Appreciation of its potential complications is vital to patient care

Emphasis should be placed on prevention of complications Meticulous surgical technique and appropriate patient selection

Recognition and management of complications intraoperatively

Timing of Laparoscopic Visceral Timing of Laparoscopic Visceral ComplicationsComplications

Complications of intra-abdominal access Choice of entry method

Morbid Obesity

Previous abdominal surgery Previous abdominal surgery

Complications of the operative procedure Thermal Energy Devices

Serial Cesarean incisions

Endometriosis

Malignancy

Obesity: Gynecologic surgical Obesity: Gynecologic surgical patients are getting patients are getting largerlarger

Prior studies (1970-1980s): approximately 15-40% of women undergoing GYN surgery are obesesurgery are obese

Recent prospective studies (1990-2000s) report that 40-90% of women are obese

Anderson et al. Am J Obstet Gynecol 1996, von Gruenigen et al. J Cancer Integ Med 2005Anderson et al. Am J Obstet Gynecol 1996, von Gruenigen et al. J Cancer Integ Med 2005

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Anthropormorphics Are Critical BMI does not tell the whole story!

Central adiposity and pannus: how does it lay when pt supine?

Waist-hip ratio critical WHR >0.85 in women correlates with

degree of central adiposity

“Apple” versus “pear shape”

Apples far more challenging and more prevalent

Intra-abdominal access very challenging

Mokdad, JAMA, 2001

Preop Considerations for Safe Laparoscopic Entry

ConsiderConsider Fleet’s Enema or mechanical bowel prep Fleet’s Enema or mechanical bowel prep Especially in morbidly obese women or those with multiple Especially in morbidly obese women or those with multiple

prior prior laparotomieslaparotomies

Randomized controlled trial Randomized controlled trial

Yang, Mansuria, Lee, Guido et al, JMIG 2011g J

Routine bowel prep vs. NA PO4 enema Routine bowel prep vs. NA PO4 enema b/fb/f GYN GYN laparoscopy were equivalent in terms of pelvic exposure, laparoscopy were equivalent in terms of pelvic exposure, bowel prep more uncomfortable bowel prep more uncomfortable

Morbidly obese pts and pts w/ adhesive Morbidly obese pts and pts w/ adhesive dzdz excludedexcluded

Surgical Beanbag and GelpadSurgical Bean Bag Steep

Trendelenberg Immobilizer

Patient Positioning:Patient Positioning:Legs, Feet and Hips Legs, Feet and Hips

Positioning more critical than everPositioning more critical than ever Higher risk of pressure sores and Higher risk of pressure sores and

neuropathies in obeseneuropathies in obese

Make sure operative bed is fitted for Make sure operative bed is fitted for iipatientpatient

May require special bed for extreme May require special bed for extreme morbid obesitymorbid obesity

Consider Consider UltrafinUltrafin stirrups for stirrups for lithotomylithotomy

Corporeal padding Corporeal padding

Padding of fingers, wrists, elbows and Padding of fingers, wrists, elbows and shoulders and knees/calvesshoulders and knees/calves

Gebhardt H., Surg Endosc 1997; 11:864-867

Patient Positioning:Patient Positioning:Legs, Feet and Hips Legs, Feet and Hips

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Tips for Safe Laparoscopic Intra-abdominal Access

Tuck both arms every time! Pad/support all pressure points, wrap hands/fingers

Use sleds or arm extenders

Position the patient yourself! Position the patient yourself! Low Low lithotomylithotomy

Thighs parallel to the floor, knees flexed at no more Thighs parallel to the floor, knees flexed at no more than 60 degrees, knee in line with than 60 degrees, knee in line with contralateralcontralateralshouldershoulder

Patient Positioning: Arms

Patient Positioning VideoPatient Positioning VideoSurgical Access and Pneumoperitoneum

Tips for Safe Laparoscopic Entry

Take the time to think about the set up before the case Individual patient characteristics

BMI and WHR—trocar placement and length/type BMI and WHR trocar placement and length/type of ports

Previous surgery

Informed consent

Communicate your needs to OR staff

Alternative Access Techniques for Safe Laparoscopy in Complex

Cases Consider Open Consider Open HassonHasson or Left Upper Quadrant or Left Upper Quadrant

(Palmer’s Point) Entry Incisions in:(Palmer’s Point) Entry Incisions in: Morbidly obese womenMorbidly obese women Morbidly obese womenMorbidly obese women

Women with multiple prior Women with multiple prior laparotomieslaparotomies

Pelvic infectionPelvic infection

Staging of gynecologic malignanciesStaging of gynecologic malignancies

Remember Remember CapaCapa Blanca!Blanca!

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Laparoscopy in Centrally Obese

Like Scuba Diving

Above the water, it may be stormy…but go below and it can be calm and smooth

Cochrane Collaboration Review on Laparoscopic Entry Techniques

Surgical Access: Veress Needle?

Creation of a pneumoperitoneum is an important step, as most complications occur at this time

C b h ll i f i i Can be challenging to perform in patients with significant truncal adiposity or reperitoneal fat or previous abdominal

Avoid use of Veress needle in morbidly obese patients or those with prior abdominal surgery

Surgical Access: Open Hasson Technique

Surgical Access: LUQ Approach

•LUQ technique most optimal? •Palmer’s point•2-5 mm long optical trocar•DO NOT elevate the abdominal wall excessively

LUQ Access VideoLUQ Access Video

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The pannus and trocar placement

In patients with a panniculus, anatomic landmarks are distorted

Old school teaching: panniculus should be pushed cephalad until the umbilicusbe pushed cephalad until the umbilicus is 8 cm cephalad to the ASIS prior to umbilical entry

Contemporary approach: LUQ or supra-umbilical approach with optical trocar

Position additional trocars more laterally and superiorly (above pannus)

Additional Trocars

Avoid bladed trocars!!

Initially increase the insufflation pressure to 20 su o p essu e o 0mmHg to allow a greater distance for trocar placement

Then reduce the pressure to 10-15 mmHg to prevent CO2 retention and decreased chest wall compliance

Visceral adiposity: optimize exposure Visceral adiposity: optimize exposure and avoid injuryand avoid injury

Fold small bowel out of the pelvis

Consider a laparoscopic fan

If RS colon is redundant, a puppeteering stitch with a 36 inch Ethibond or PDS suture can be placed through the RS epiploica and brought through the skin to improve pelvic exposure

Video Puppeteering Stitch

Incidence of bowel injury at laparoscopy

0.13% by van 0.13% by van derder VoortVoort et alet al Most common location of injury was the small bowel (55.8%), Most common location of injury was the small bowel (55.8%),

followed by the large intestine (38.6%) and the stomach (3.9%)followed by the large intestine (38.6%) and the stomach (3.9%)

Common signs that a bowel injury has occurred include Common signs that a bowel injury has occurred include g j yg j yfoulfoul--smelling gas, return of bowel contents, high smelling gas, return of bowel contents, high insufflationinsufflation pressures, and asymmetric distensionpressures, and asymmetric distension

Early diagnosis criticalEarly diagnosis critical----morbidity and mortality associated morbidity and mortality associated with bowel injuries appear significantly affected by the time with bowel injuries appear significantly affected by the time at which injury is identified at which injury is identified View the initial View the initial trocartrocar site through an alternative port if there is site through an alternative port if there is

concern about anterior wall adhesionsconcern about anterior wall adhesions

Laparoscopic Bowel Injuries

Gastrointestinal trauma occurs during creation of pneumoperitoneum or during the operative portion of laparoscopy

Both types of injuries frequent in the face of previous yp j q psurgery or prior infection that has resulted in the fixation of the bowel to other structures, particularly to the anterior abdominal wall

Approximately 40% of bowel injuries are access related and occur with the insufflation needle or with a trocar.

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Bowel Injuries

In review by van der Voort et al, of 273 bowel injuries, 3 (1.1%) and 2 (0.7%) occurred with the grasping forceps and scissors, respectively. In contrast, 70 (25.6%) thermal injuries were reported and occurred with either a coagulating instrument or the laserg g

Multifunctional electrothermal bipolar vessel sealers and ultrasonic coagulating shears superior in achieving hemostasis when compared with older monopolar and bipolar electrocoagulation devices Also appear to be safer, in that lateral thermal injury is more

common in monopolar and bipolar instruments

Sharp or Thermal Bowel InjuriesSharp or Thermal Bowel Injuries Sharp (non-thermal) injury to small bowel or colon: repair

primarily and laparoscopically with 3-0 delayed absorbable suture; interrupted sutures perpendicular to long axis of bowel

Superficial, brief thermal injury: oversew laparoscopically with 3-0 delayed absorable suture

Deeper injury or full thickness thermal energy identified intraop: resect small bowel (laparoscopic if possible) and reanastamose; colon repair primarily beyond site of thermal spread

Unrecognized, late perforations may manifest several days to weeks following the surgery. If full-thickness perf diagnosis delayed, sepsis, multiorgan failure, and even death may occur—requires laparotomy to explore adequately and diversion

Incidence Bladder Injuries With respect to GYN surgery, the bladder remains the most

common site of injury

Injury to the bladder and/or ureter during laparoscopic surgery used to be rare

However, as laparoscopy has expanded to include more , p py pcomplicated procedures, injuries involving the GU system have also increased

Incidence of bladder injury during laparoscopy between 0.02% and 8.3%. Most often involves the bladder dome.

The most common laparoscopic procedure associated with bladder injury is laparoscopic-assisted vaginal hysterectomy and most frequently occurs while conducting sharp, electrosurgical dissection.

Approach to the Difficult Bladder Dissection

Prophylactic Cystourethroscopy Post-TLH

An Ounce of Prevention…

Ibeanu et al, Obstet Gynecol, 2009

Video

Jelovsek, JSLS 2007

Conclusions The best way to manage visceral complications that occur

during laparoscopy is to anticipate and avoid them!

>50% of visceral injuries occur with intra-abdominal access

Proper positioning, patient selection and choice of trocarp p g pand abdominal access sites are keys to avoiding trouble

Intra-operative recognition of visceral injuries are vital

Many visceral complications can be managed laparoscopically if immediately recognized, with minimal increased morbidity to the patient

23

References1. Munro MG. Laparoscopic access: complications, technologies, and techniques. Curr

Opin Obstet Gynecol. 2002;14:365–374. [PubMed]

2. Chapron CM, Pierre F, Lacroix S, et al. Major vascular injuries during gynecologic laparoscopy. J Am Coll Surg. 1997;185:461–465. [PubMed]

3. Ahmad G, Duffy JM, Phillips K, Watson A. Laparoscopic entry techniques. Cochrane Database Syst Rev. 2008;2 CD006583.

4. Jansen FW, Kolkman W, Bakkum EA, et al. Complications of laparoscopy: an inquiry about closed- versus open-entry technique. Am J Obstet Gynecol. 2004;190:634–638.

5. Bemelman WA, Dunker MS, Busch OR, et al. Efficacy of establishment of pneumoperitoneum with the Veress needle, Hasson trocar, and modified blunt trocar(TrocDoc): a randomized study. J Laparoendosc Adv Surg Tech A. 2000;10:325–330.

6. String A, Berber E, Foroutani A, et al. Use of the optical access trocar for safe and rapid entry in various laparoscopic procedures. Surg Endosc. 2001;15:570–573. [PubMed]

7. Sharp HT, Dodson MK, Draper ML, et al. Complications associated with optical-access laparoscopic trocars. Obstet Gynecol. 2002;99:553–555. [PubMed]

8. Childers JM, Brzechffa PR, Surwit EA. Laparoscopy using the left upper quadrant as the primary trocar site. Gynecol Oncol. 1993;50:221–225. [PubMed]

9. Neely MR, McWilliams R, Makhlouf HA. Laparoscopy: routine pneumoperitoneum via the posterior fornix. Obstet Gynecol. 1975;45:459–460

AcknowledgmentsAcknowledgments

Michael Michael FrumovitzFrumovitz, MD, MD

AAGLAAGL

My patientsMy patients

24

Work‐up of Adnexal Masses –CA125, HE4, OVA1 or None of the

Above?

Pedro F. Escobar, M.D.Associate Professor of Surgery

Director of Laparoscopy and Robotic SurgeryDepartment of OB/GYN and Women’s Institute

Cleveland Clinic


Objectives

• Review ovarian cancer epidimiology

• Review appropriate pre‐operative assessment of adnexal masses (Imaging biomarkers etc )of adnexal masses (Imaging, biomarkers, etc.)

• Identify important considerations to be made prior to proceeding with surgery

Prevalence: Approx. 22k new cases of ovarian

cancer and 15k deaths in 20111

Lifetime risk: 1/71 (1.4%)2,3

Ovarian CancerOvarian CancerFifth leading cause of female cancer death in the United States1

Survival Percentage Based Upon <5yrs1

1. American Cancer Society website – 9/20112. National Cancer Institute, 20113. Surveillance, Epidemiology, and End Results (SEER) Program: National Cancer Institute, 2008

Survival Percentage Based Upon <5yrs

Stage Percent of Cases Survival

I 24% 95%

II 6% 65%

III 55% 15%‐30%

IV 15% 0%‐20%

Overall 50%

Cancer Mortality Rates: 1930 Cancer Mortality Rates: 1930 –– 200320034,54,5

4. Source: US Mortality Public Use Data Tapes 196‐2003, US Mortality Volumes 1930‐19595. National Center for health Statistics, Center for Disease Control and Prevention, 2006

• There are 110M women >18 yrs in the US6

• How common are adnexal masses7

– Premenopausal women

14% annual incidence (13M)

30% prevalence (27M)

Challenge of Adnexal MassesChallenge of Adnexal Masses

‒Postmenopausal women

5% annual incidence (1.5M)

16% prevalence (5M)

• 30% of unilocular & 45% of complex tumors typically persist

6. United States Census Bureau, 20107. Data from University of Kentucky Ovarian Cancer Screening Program, 2009 (N=27,000)

25

• 15% of ovarian neoplasms in premenopausal women are malignant

• Non‐inflammatory ovarian

Ovarian NeoplasmsOvarian Neoplasms

• 50% of ovarian neoplasms in postmenopausal women are malignant

• Benign epithelial tumor

Pre Menopausal Post Menopausal

Non inflammatory ovarian tumors‒ 70% functional cysts

‒ 20% neoplastic

‒ 10% endometriomas

• Other‒ Inflammatory process,

bowel

Benign epithelial tumor

• Stromal tumor‒ Granulosa cell

‒ Fibroma

‒ Thecoma

• Epithelial ovarian cancer

• Metastatic cancer

PREOPERATIVE EVALUATION

• Physical Evaluation‒ Pelvic, abdominal & lymph node survey

• Biomarkers

• Imaging study

Standard Approach to Evaluation of Adnexal MassStandard Approach to Evaluation of Adnexal Mass

• Imaging study‒ TVU

‒ MR or CT scan

Ovarian detection on pelvic examination is infrequent in women ≥ 55 years old (30%)

Pelvic ExaminationPelvic Examination

Ovarian detection is exceedingly difficult in women weighing

A large uterus (weight ≥ 200 g) makes ovarian

Detecting Ovarian Tumors12

≥ 55 years old (30%)

12. Ueland, FR et al. Gynecol Oncol,. VOL 99, Issue 2, November 2005, Pages 400‐403

g gat least 200 lb. (9%) palpation unlikely

(16%)

Adnexal MassAccuracy Of Physical Examination

Authors Pts/Exams Yrs. Cancers

Garrett 26,635 / 74,868 20 6

McFarlane 1319/80,753 15 6

Andolf 795/878 1 0

Med J Aust 1:1239, 1970Am J Obstet Gynecol 80:224, 1955Br J Obstet Gynecol 93:1288, 1988

26

Pelvic Exam Ultrasound P value

Age ≥ 55 0.30 0.74 <0.001

Patient wt ≤ 200lb

0.09 0.73 <0.001

Pelvic Exam vs. UltrasoundPelvic Exam vs. Ultrasound1212

Uterine wt ≥ 200g

0.16 0.80 <0.001

So Pelvic Examination……

“In 74,000 examinations, we have found six cases of symptomless cancer of the ovary. Five of these patients are dead, and one survives. The conclusion is obvious Vaginal examinationThe conclusion is obvious. Vaginal examination as a means of early diagnosis of cancer of the ovary is a waste of time.”

Garrett, WJ Med J Aust 1:1239, 1970

ULTRASOUND

Adnexal Mass Transvaginal Ultrasound

• Most widely used imaging modality

• No alternative imaging modality has sufficient superiority to justify its routine use

• Advantages• Widespread availability

• Good tolerability

• Reasonable cost‐effectiveness

• Limitations• Lack of specificity, poor PPV for malignancy, especially in pre‐menopausal women

• Unilateral

• Simple, unilocular

• Septated (MI<5)

• Bilateral

• Complex (MI ≥ 5)‒ Solid wall abnormalities

Internal papillations

Benign Malignant

Ultrasound Characteristics of Ovarian NeoplasmsUltrasound Characteristics of Ovarian Neoplasms

• No ascites

• Resolution

‒ Internal papillations

• Ascites

• Persistence or growth

Simple “functional” ovarian cyst

Hydrosalpinx

27

Hemorrhagic cyst

Endometrioma

Cystadenocarcinoma

Serous cystadenocarcinoma

Mature teratoma

Ultrasound scoreBenign( 290)

Malignant( 75)

Risk of Malignancy by Ultrasound FindingsRisk of Malignancy by Ultrasound Findings••Multiloculated cystsMultiloculated cysts••Solid areas Solid areas ••Bilateral lesions Bilateral lesions ••AscitesAscites••Evidence of intraabdominal metastasesEvidence of intraabdominal metastases

(n=290) (n=75)

0 27% 4%

1 39% 17%

2-5 34% 79%

What does Color Doppler Add?

• Altered angiogenesis in neoplastic growth

• Vessels lack of muscularis

• A V shunting with low

DD

eloc

ity (

eloc

ity (��

))

SS SS

Systolic/Diastolic Ratio= S/DSystolic/Diastolic Ratio= S/D

Resistance Index= SResistance Index= S--D/SD/S

P l tilit I d SP l tilit I d S D/MD/M• A‐V shunting with low impedance and high flow velocity

• High diastolic flow suggestive of malignancy

VeVeCharacteristics of Malignancy:Characteristics of Malignancy:

-- PSV >16cm/sPSV >16cm/s

-- RI <0.45RI <0.45

-- Flow in central mass/ papillaFlow in central mass/ papilla

Pulsatility Index = SPulsatility Index = S--D/MeanD/Mean

Kentucky Morphology Index1

MI ≥ 5Kentucky Morphology Index1

MI ≥ 5

Ascites1. Ueland, FR, et al. Gyn Oncol, 2003

60

70

80

90

100

Ultrasound Ultrasound ‐‐ Kentucky Kentucky Morphology IndexMorphology Index1313

0

10

20

30

40

50

5 6 7 8 9 10

% Benign

% Malignant

13. Ueland et al. Gynecol Oncol, VOL 91, Issue 1, October 2003, Pages 46-50

n=442 ovarian tumors

28

No Ovarian Tumor BiopsyNo Ovarian Tumor Biopsy

• Percutaneous FNA cytology of cystic ovarian tumors has low cancer sensitivity, ranging from 25% ‐ 82%14

• 25% ‐ 50% of aspirated cystic ovarian tumors will recur within 1 15

14. ACOG Practice Bulletin no 83, 2006. Mizuno M, et al. Oncology. 65:29, 200315. Sainz de la Cuesta R, et al. Obstet Gynecol. 84:1 1994

1 year15

• Aspiration of malignant cystic tumor may disseminate the cancer, increase the stage, and worsen the prognosis

Adnexal MassImaging Modality Comparison

Laparoscopic Management

GYN GYO

BiomarkersBiomarkers

CA125CA125 CEACEA CA19CA19‐‐99 LDHLDH

ββ‐‐hCGhCG AFPAFP HE4HE4

BiomarkersBiomarkers

• CEA

‒ Mucinous neoplasms

• CA19‐9

‒ Gastrointestinal (pancreatic)

• LDH*

• β‐hCG*

‒ Pregnancy

‒ Trophoblastic disease

‒ Germ cell tumors (choriocarcinoma)

*‒ Germ cell tumors (Dysgerminoma)

• AFP*

‒ Hepatic neoplasms

‒ Germ cell tumors (endodermal sinus tumors)

*Most beneficial in young women with solid tumors

• Antigen derived from:16

‒ Coelomic epithelium (pericardium, pleura, peritoneum)

‒Mullerian epithelium (tubal, endometrial, endocervical)

• Two different assays

CA125 ≤ 35 U/mL

CA125CA125

‒ CA125 ≤ 35 U/mL

‒ CA125‐II < 20 U/mL

• Expressed by 80% advanced ovarian cancers16,17

‒ Poorly expressed in ovarian mucinous, clear cell, undifferentiated, sarcomatoid malignancies

• Expressed by 50% of early stage ovarian cancers16,17

16. Bast RC Jr, Klug TL, St John E, et al. N Engl J Med 309:883‐887, 198317. Jacobs I, Bast RC Jr. Human Reproduction vol. 4, No. 1:1‐12, 1989

29

• Antigen derived from:

‒ Human epididymis protein

• Product of the WFDC2 (HE4) gene which is over expressed in patients with ovarian carcinoma18

‒ Falsely elevated or depressed values of HE4 may occur in samples containing human anti mouse antibodies

HE4HE4

samples containing human anti‐mouse antibodies (HAMA)19

• Reference range ≤ 150pM19

• FDA‐cleared to monitor cancer treatment with other clinical methods

‒ HE4 should not be used for monitoring patients with mucinous or germ cell ovarian cancer18

18. Quest Diagnostics Website www.questdiagnostics.com19. HE4 Product Insert, Fujirebio Diagnostics, Inc.

ALGORITHMS

• Proteomic screening test developed by Correlogic Systems, Inc. for the early detection of Epithelial Ovarian Cancer

• July 12, 2004 ‐ FDA states that OvaCheck is a medical device and therefore requires FDA premarket review

• “In the opinion of SGO more research is needed to

OvaCheck®OvaCheck®

• In the opinion of SGO, more research is needed to validate the test’s effectiveness before offering it to the public”20

• NCCN 2009 Guidelines do not comment on the use of proteomics for the early detection of malignancies

• Currently unavailable in the US

20. Society of Gynecologic Oncologists, Feb 7, 2004

• Developed by Yale University & commercialized by LabCorp

• 6 protein biomarker panel used to assess the presence of early stage ovarian cancer in high‐risk women

• Sept 2008, FDA required additional clinical validation and requested OvaSure be removed from the market

OvaSure™OvaSure™

• “After reviewing OvaSure’s materials, it is our opinion that additional research is needed to validate the test’s effectiveness before offering it to women outside of the context of a research study conducted with appropriate informed consent under the auspices of an institutional review board.” Society of Gynecologic Oncologists21

• Currently unavailable in the US

21. Society of Gynecologic Oncologists, July 8, 2008

FDA News Release

• For Immediate Release: Sept. 11, 2009

• Media Inquiries: Peper Long, 301‐796‐4671, [email protected]

• Consumer Inquiries: 888‐INFO‐FDA

• FDA Clears a Test for Ovarian Cancer

T t h l id tif t ti l li i id i l• Test can help identify potential malignancies, guide surgical decisions

• The U.S. Food and Drug Administration today cleared a test that can help identify ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, can help patients and health care professionals decide what type of surgery should be done and by whom.

Risk of Ovarian Malignancy AlgorithmRisk of Ovarian Malignancy Algorithm

• Initially submitted ROMA™ to FDA for review by Fujirebio Diagnostics, Inc. in Dec 2008

‒ Submission pulled by manufacturer prior to FDA decision

• Resubmitted in Nov 2010 after conducting a new clinical 22trial ‐ cleared by FDA on Sept 6, 201122

• Indicated for women with a pelvic mass who are planned for surgery.

• High sensitivity limited to EOC and LMP tumors

• Is not a screening or stand alone test

22. Fujirebio Diagnostics Press Release, Sept 6, 2011ROMA is a trademark of Fujirebio Diagnostics, Inc.

30

Multivariate Index AssayMultivariate Index Assay2323

23. Wall Street Journal, Test to Help Determine If Ovarian Masses Are Cancer , Johannes L., Mar 9, 2010

Multivariate Index Assay Multivariate Index Assay ‐‐ ““The OVA1® testThe OVA1® test2424””

• Five Biomarkers (Apolipoprotein A1, Transthyretin, β2 Microglobulin, Transferrin, CA125‐II)

• Triage tool for surgical decision making

• OVA1 uses a proprietary algorithm to evaluate the five• OVA1 uses a proprietary algorithm to evaluate the five markers and produces a single score from 0‐10

24. OVA1 Instructions for Use, Vermillion, Inc. Austin TX

Test Range 0‐10 Premenopausal Postmenopausal

Low Risk < 5.0 < 4.4

High Risk ≥ 5.0 ≥ 4.4

Premenopausal (< 50 yrs)

• CA125 > 200 U/mL

• Ascites

• Evidence of abdominal/distant mets (by exam/imaging study)

Postmenopausal (>50 yrs)

• CA125 > 35 U/mL

• Ascites

• Evidence of abdominal/distant mets (by exam/imaging study

SGO/ACOG Referral Criteria for Women SGO/ACOG Referral Criteria for Women w/ Adnexal Mass to GynOncw/ Adnexal Mass to GynOnc2525

• First degree family history of breast/ovarian cancer

• First degree family history of breast/ovarian cancer

• Nodular/fixed pelvic mass

25. Committee Opinion No. 477. American College of Obstetricians and Gynecologists. Obstet Gynecol 2011; 117: 742‐6

Premenopausal (n=235) Postmenopausal (n=281)

ACOG ACOG w/ OVA1 ACOG ACOG w/ OVA1

Sensitivity, % 58 91 84 95

Specificity, % 77 43 56 26

PPV, % 38 28 58 47

NPV, % 89 95 84 88

June 2011: OVA1 & the College GuidelinesJune 2011: OVA1 & the College Guidelines2626

• When replacing CA125 with OVA1 in the ACOG guidelines >90 of EOC were detected and 80% of all malignancies missed by the current guidelines

• Improved sensitivity (58% ‐ 91%) and NPV (89% ‐ 95%) for premenopausal women

• The OVA1 has much better sensitivity for early stage cancers than CA 125‒ Premenopausal (47% ‐ 88%)‒ Postmenopausal (88% ‐ 100%)

26. Miller R, et al. Obstet Gynecol 2011:VOL 117, NO. 6, June 2011

“Effectiveness of a Multivariate Index Assay in the Preoperative Assessment of Ovarian Tumors”27

Subjects OVA1 CA125‐II

All cancers (n=161) 92.5% 68.9%

All epithelial ovarian cancers 99 0% 82 3%

June 2011: OVA1 & Preoperative June 2011: OVA1 & Preoperative AssessmentAssessment

(n=96)99.0% 82.3%

Early stage EOC (n=41) 97.6% 65.9%

Premenopausal women w/ early stage EOC (n=14)

92.9% 35.7%

Overall, the OVA1 detected 76% of malignancies missed by CA125‐II, including all advanced stage malignancies.*

27. Ueland, FR, et al. Obstet Gynecol 2011:VOL 117, NO. 6, June 2011

March 2011: Updated Committee OpinionMarch 2011: Updated Committee Opinion2525

• First update since original publication (Dec 2002)• “(OVA1) May be useful for evaluating women with a pelvic mass”• “(OVA1) Appears to improve predictability of ovarian cancer in women with pelvic masses”

31

SGO Statement on OVA1SGO Statement on OVA12828

September, 2009

SGO recognizes the importance of accurate detection of ovarian cancer and referral to gynecologic cancer specialists for women with ovarian masses. The OVA1 test, recently approved by the FDA, measures the levels of five proteins in blood samples from women with a known ovarian mass that have been reported to change when ovarian cancer is present, and may be a useful tool in identifying women who should be referred to a gynecologic oncologist for their ovarian cancer surgery.

As physicians who are expert in the care of women with gynecologic cancers, members of the SGO are supportive of scientific advances such as OVA1 that may help healthcare providers better detect when referral to a gynecologic oncologist is indicated. However, this test has not been approved for use as an ovarian cancer screening tool, nor has it been proven to result in early detection or reduce the risk of death from this disease.

SGO does not formally endorse or promote any specific products or brands as may be implied by in the product announcement.

28. Society of Gynecologic Oncologists, September 11, 2009

Limitations in Clinical PracticeLimitations in Clinical Practice2424

• Not a screening test!!!

• Not a stand‐alone diagnostic test. It should be used in conjunction with clinical evaluation

• A negative test, in the setting of a positive pre‐surgical assessment, should not preclude oncology referral!!!

• Triglyceride > 4.5 g/L may interfere with the test

• Not intended to determine whether surgery is necessary!!!

• Incorrect use of the test may risk unnecessary testing, surgery and/or delayed diagnosis

• If you do what you’ve always done, you’re gonna get what you always got.

SummaryConclusions

– Yogi Berra

Case 1Case 136 y.o. G0 woman with a history of severe endometriosis presents with pelvic pain and irregular bleeding.P.E. Tender, 6 cm pelvic mass.

Pap smear and endometrial biopsy (-)F.H. Aunt had ovarian cancer at age 59Labs WBC= 8

β-hCG (-)CA125= 192 U/mLOVA1= 6.5 (<5.0)

Pelvic UltrasoundPelvic Ultrasound After participating in this session I will do the following in this situation:

• A. Referred patient to Gynecologic Oncologist or proceed with surgery with GYO back‐up

• B. Observation and Repeat U/S in 6‐8 weeks

O d d S• C. Ordered a CT‐Scan

• D. Proceed with surgery with no GYO back‐up

32

Surgery with Gynecologic Oncologist

Surgery with Gynecologic Oncologist

Stage IIA, grade 2 endometrioid adenocarcinoma of ovary

Case 2Case 266 y.o. woman presents for routine annual examination. Some urinary frequency and mild cough and SOB. Single episode of spotting 3 months ago.P E Palpable 8 cm pelvic massP.E. Palpable, 8 cm pelvic mass.

Pap smear and endometrial biopsy (-)F.H. Aunt had ovarian cancer at age 59Labs WBC= 8

CA125= 42 U/mLOVA1 - 4.0 (<4.4)

Pelvic Ultrasound

Ascites

After participating in this session I will do the following in this situation:

• A. Referred patient to Gynecologic Oncologist

•

• B. Observation and Repeat U/S in 3‐4 weeks

• C. Ordered MRI of the pelvis

• D. Proceed with a laparotomy or LSC

Surgery with OB/GynSurgery with OB/Gyn

Benign ovarian cystadenofibroma and associated Meigs syndrome

ReferencesAmerican Cancer Society website – 9/2011National Cancer Institute, 2011Surveillance, Epidemiology, and End Results (SEER) Program: National Cancer Institute, 2008

Source: US Mortality Public Use Data Tapes 196‐2003, US Mortality Volumes 1930‐1959

National Center for health Statistics, Center for Disease Control and Prevention, 2006United States Census Bureau, 2010Data from University of Kentucky Ovarian Cancer Screening Program, 2009 (N=27,000)Ueland, FR et al. Gynecol Oncol,. VOL 99, Issue 2, November 2005, Pages 400‐403

Med J Aust 1:1239, 1970

Am J Obstet Gynecol 80:224, 1955

Br J Obstet Gynecol 93:1288, 1988ACOG Practice Bulletin no 83, 2006. Mizuno M, et al. Oncology. 65:29, 2003Sainz de la Cuesta R et al Obstet Gynecol 84:1 1994Sainz de la Cuesta R, et al. Obstet Gynecol. 84:1 1994Bast RC Jr, Klug TL, St John E, et al. N Engl J Med 309:883‐887, 1983Jacobs I, Bast RC Jr. Human Reproduction vol. 4, No. 1:1‐12, 1989Quest Diagnostics Website www.questdiagnostics.comHE4 Product Insert, Fujirebio Diagnostics, Inc.Society of Gynecologic Oncologists, Feb 7, 2004Society of Gynecologic Oncologists, Feb 7, 2004

Fujirebio Diagnostics Press Release, Sept 6, 2011

ROMA is a trademark of Fujirebio Diagnostics, Inc.

Wall Street Journal, Test to Help Determine If Ovarian Masses Are Cancer , Johannes L., Mar 9, 2010

Society of Gynecologic Oncologists, September 11, 2009ACOG Practice Bulletin no 83, 2006. Mizuno M, et al. Oncology. 65:29, 2003Sainz de la Cuesta R, et al. Obstet Gynecol. 84:1 1994

33

Adnexal Masses and PregnancyAdnexal Masses and Pregnancy

Jubilee Brown, M.D.Jubilee Brown, M.D.Associate ProfessorAssociate Professor

Jubilee Brown, M.D.Jubilee Brown, M.D.Associate ProfessorAssociate ProfessorAssociate ProfessorAssociate Professor

Department of Gynecologic OncologyDepartment of Gynecologic Oncology

Associate ProfessorAssociate Professor

Department of Gynecologic OncologyDepartment of Gynecologic Oncology

I have no financial relationships to I have no financial relationships to disclose.disclose.

ObjectivesObjectives

• Describe the indications for removal of an adnexal mass during pregnancy

• Examine the role of minimally invasiveExamine the role of minimally invasive surgery in the removal of the adnexal mass during pregnancy

• Review the safety profile surrounding the use of minimally invasive surgery in pregnancy

Indications for removal of an adnexal Indications for removal of an adnexal mass during pregnancymass during pregnancy

BackgroundBackground

•• Prevalence of pregnancies complicated by an Prevalence of pregnancies complicated by an adnexal mass: 1adnexal mass: 1--4%4%

•• Most are < 5 cm and resolve by 2Most are < 5 cm and resolve by 2ndnd trimestertrimester

•• 5% are malignant…ovarian cancer is the 55% are malignant…ovarian cancer is the 5thth most most common cancer diagnosed during pregnancycommon cancer diagnosed during pregnancy

•• Prevalence of pregnancies complicated by an Prevalence of pregnancies complicated by an adnexal mass: 1adnexal mass: 1--4%4%

•• Most are < 5 cm and resolve by 2Most are < 5 cm and resolve by 2ndnd trimestertrimester

•• 5% are malignant…ovarian cancer is the 55% are malignant…ovarian cancer is the 5thth most most common cancer diagnosed during pregnancycommon cancer diagnosed during pregnancycommon cancer diagnosed during pregnancycommon cancer diagnosed during pregnancy

•• May present with elevated AFP (germ cell tumors) May present with elevated AFP (germ cell tumors) on triple screen in 1on triple screen in 1stst trimestertrimester

–– Horowitz, Clin Obstet Gynecol 2012Horowitz, Clin Obstet Gynecol 2012

common cancer diagnosed during pregnancycommon cancer diagnosed during pregnancy

•• May present with elevated AFP (germ cell tumors) May present with elevated AFP (germ cell tumors) on triple screen in 1on triple screen in 1stst trimestertrimester

–– Horowitz, Clin Obstet Gynecol 2012Horowitz, Clin Obstet Gynecol 2012

34

When to operate?When to operate?

•• Balance risks of surgery to mother and fetusBalance risks of surgery to mother and fetus

•• Risk of Risk of electiveelective surgery is lowsurgery is low–– No association with miscarriage, PTL, PTD, PROMNo association with miscarriage, PTL, PTD, PROM

•• Risk of Risk of emergentemergent surgery is higher surgery is higher 22% risk of PTL (Lee et al)22% risk of PTL (Lee et al)

•• Balance risks of surgery to mother and fetusBalance risks of surgery to mother and fetus

•• Risk of Risk of electiveelective surgery is lowsurgery is low–– No association with miscarriage, PTL, PTD, PROMNo association with miscarriage, PTL, PTD, PROM

•• Risk of Risk of emergentemergent surgery is higher surgery is higher 22% risk of PTL (Lee et al)22% risk of PTL (Lee et al)–– 22% risk of PTL (Lee et al)22% risk of PTL (Lee et al)

•• Down side of observationDown side of observation–– Risk of treatment delay of malignancyRisk of treatment delay of malignancy

–– Ovarian torsion: 5% of adnexal masses, 20% if 6Ovarian torsion: 5% of adnexal masses, 20% if 6--8 cm; 8 cm; 60% of time between 1060% of time between 10--17 weeks17 weeks

–– Obstruction of labor or cyst ruptureObstruction of labor or cyst rupture–– Horowitz, Clin Obstet Gynecol 2012Horowitz, Clin Obstet Gynecol 2012

–– 22% risk of PTL (Lee et al)22% risk of PTL (Lee et al)

•• Down side of observationDown side of observation–– Risk of treatment delay of malignancyRisk of treatment delay of malignancy

–– Ovarian torsion: 5% of adnexal masses, 20% if 6Ovarian torsion: 5% of adnexal masses, 20% if 6--8 cm; 8 cm; 60% of time between 1060% of time between 10--17 weeks17 weeks

–– Obstruction of labor or cyst ruptureObstruction of labor or cyst rupture–– Horowitz, Clin Obstet Gynecol 2012Horowitz, Clin Obstet Gynecol 2012

Risk of delayRisk of delay

•• 36 year old female with 8 cm complex adnexal mass36 year old female with 8 cm complex adnexal mass

•• 17 weeks pregnant17 weeks pregnant

•• Normal CANormal CA--125125

•• Advised to have surgery; sought second opinion Advised to have surgery; sought second opinion and declined surgeryand declined surgery

•• 36 year old female with 8 cm complex adnexal mass36 year old female with 8 cm complex adnexal mass

•• 17 weeks pregnant17 weeks pregnant

•• Normal CANormal CA--125125

•• Advised to have surgery; sought second opinion Advised to have surgery; sought second opinion and declined surgeryand declined surgeryg yg y

•• Mass grew during pregnancy to 15 cmMass grew during pregnancy to 15 cm

•• Patient delivered by vaginal delivery at termPatient delivered by vaginal delivery at term

•• Underwent a laparoscopic USO 8 weeks post Underwent a laparoscopic USO 8 weeks post delivery. Cyst ruptured. delivery. Cyst ruptured.

•• Pathology: Clear cell carcinomaPathology: Clear cell carcinoma

•• Outcome: hospitalized with brain metsOutcome: hospitalized with brain mets

g yg y

•• Mass grew during pregnancy to 15 cmMass grew during pregnancy to 15 cm

•• Patient delivered by vaginal delivery at termPatient delivered by vaginal delivery at term

•• Underwent a laparoscopic USO 8 weeks post Underwent a laparoscopic USO 8 weeks post delivery. Cyst ruptured. delivery. Cyst ruptured.

•• Pathology: Clear cell carcinomaPathology: Clear cell carcinoma

•• Outcome: hospitalized with brain metsOutcome: hospitalized with brain mets

No firm guidelines…best recommendationsNo firm guidelines…best recommendations

•• Persist into second trimesterPersist into second trimester

•• > 10 cm, or are symptomatic, or are solid, or are > 10 cm, or are symptomatic, or are solid, or are mixed solid/cystic suspicious for malignancymixed solid/cystic suspicious for malignancy

•• Goals:Goals:–– Remove mass to avoid pregnancy complicationsRemove mass to avoid pregnancy complications

•• Persist into second trimesterPersist into second trimester

•• > 10 cm, or are symptomatic, or are solid, or are > 10 cm, or are symptomatic, or are solid, or are mixed solid/cystic suspicious for malignancymixed solid/cystic suspicious for malignancy

•• Goals:Goals:–– Remove mass to avoid pregnancy complicationsRemove mass to avoid pregnancy complications

–– Obtain a diagnosisObtain a diagnosis

–– Stage or debulk if a cancer is presentStage or debulk if a cancer is present

–– Obtain a diagnosisObtain a diagnosis

–– Stage or debulk if a cancer is presentStage or debulk if a cancer is present

The role of minimally invasive surgery in the removal of the adnexal mass

The role of minimally invasive surgery in the removal of the adnexal massin the removal of the adnexal mass

during pregnancyin the removal of the adnexal mass

during pregnancy

Surgical GoalsSurgical Goals

•• Peritoneal washingsPeritoneal washings

•• Explore the abdomenExplore the abdomen

•• Evaluate the contralateral ovaryEvaluate the contralateral ovary

•• Avoid manipulating the uterusAvoid manipulating the uterus

•• Peritoneal washingsPeritoneal washings

•• Explore the abdomenExplore the abdomen

•• Evaluate the contralateral ovaryEvaluate the contralateral ovary

•• Avoid manipulating the uterusAvoid manipulating the uterus–– Abruption, PTL, fetal lossAbruption, PTL, fetal loss

•• Remove the cyst if appears likely to be benign, or Remove the cyst if appears likely to be benign, or involved ovary/tube if excrescences, solid, presence involved ovary/tube if excrescences, solid, presence of ascites)of ascites)

•• Frozen sectionFrozen section

–– Abruption, PTL, fetal lossAbruption, PTL, fetal loss

•• Remove the cyst if appears likely to be benign, or Remove the cyst if appears likely to be benign, or involved ovary/tube if excrescences, solid, presence involved ovary/tube if excrescences, solid, presence of ascites)of ascites)

•• Frozen sectionFrozen section

TO STAGE OR NOT TO STAGE?...TO STAGE OR NOT TO STAGE?...

•• Temper enthusiasm with clinical benefit Temper enthusiasm with clinical benefit ------ how are how are you going to use this information?you going to use this information?–– Germ cell tumor that appears early? Full staging Germ cell tumor that appears early? Full staging ––

completely guides therapy completely guides therapy –– no chemo for Stage IA grade no chemo for Stage IA grade 1 immature teratoma or dysgerminoma1 immature teratoma or dysgerminoma

•• Temper enthusiasm with clinical benefit Temper enthusiasm with clinical benefit ------ how are how are you going to use this information?you going to use this information?–– Germ cell tumor that appears early? Full staging Germ cell tumor that appears early? Full staging ––

completely guides therapy completely guides therapy –– no chemo for Stage IA grade no chemo for Stage IA grade 1 immature teratoma or dysgerminoma1 immature teratoma or dysgerminoma

–– No wedge resection of contralateral ovaryNo wedge resection of contralateral ovary

–– +/+/-- benefit of cytoreductionbenefit of cytoreduction

–– No prospective randomized clinical trialNo prospective randomized clinical trial

–– No wedge resection of contralateral ovaryNo wedge resection of contralateral ovary

–– +/+/-- benefit of cytoreductionbenefit of cytoreduction

–– No prospective randomized clinical trialNo prospective randomized clinical trial

35

TimingTiming

•• Early 2Early 2ndnd trimester: 17trimester: 17--19 weeks19 weeks–– Decreased risk of miscarriageDecreased risk of miscarriage

–– Functional cysts resolved, eliminating unnecessary Functional cysts resolved, eliminating unnecessary surgerysurgery

–– Placenta has taken over progesterone productionPlacenta has taken over progesterone production

•• Early 2Early 2ndnd trimester: 17trimester: 17--19 weeks19 weeks–– Decreased risk of miscarriageDecreased risk of miscarriage

–– Functional cysts resolved, eliminating unnecessary Functional cysts resolved, eliminating unnecessary surgerysurgery

–– Placenta has taken over progesterone productionPlacenta has taken over progesterone productionp g pp g p

–– FHT preop and postop, no evidence for tocolyticsFHT preop and postop, no evidence for tocolytics

p g pp g p

–– FHT preop and postop, no evidence for tocolyticsFHT preop and postop, no evidence for tocolytics

Minimally Invasive SurgeryMinimally Invasive Surgery

Issues

•• Increased pressures ... Increased pressures ...

Issues

•• Increased pressures ... Increased pressures ...

Benefits

•• Shorter recovery timeShorter recovery time

Benefits

•• Shorter recovery timeShorter recovery time ppdecreased venous return … decreased venous return … decreased cardiac output decreased cardiac output … fetal hypotension / … fetal hypotension / hypoxia / acidosishypoxia / acidosis

•• Potential for injury to Potential for injury to uterusuterus

ppdecreased venous return … decreased venous return … decreased cardiac output decreased cardiac output … fetal hypotension / … fetal hypotension / hypoxia / acidosishypoxia / acidosis

•• Potential for injury to Potential for injury to uterusuterus

Shorter recovery timeShorter recovery time•• Decreased operative Decreased operative

timetime•• Decreased length of Decreased length of

staystay•• Lower morbidityLower morbidity•• Less discomfortLess discomfort

Shorter recovery timeShorter recovery time•• Decreased operative Decreased operative

timetime•• Decreased length of Decreased length of

staystay•• Lower morbidityLower morbidity•• Less discomfortLess discomfort

The safety profile of minimally invasive The safety profile of minimally invasive surgery in pregnancysurgery in pregnancy

Is MIS safe in pregnancy?Is MIS safe in pregnancy?

•• 9 women who underwent laparoscopic surgery in 9 women who underwent laparoscopic surgery in first or second trimester for an adnexal massfirst or second trimester for an adnexal mass

•• Cystectomy or oophorectomy performedCystectomy or oophorectomy performed

•• Mean uterine resistance index and umbilical artery Mean uterine resistance index and umbilical artery

•• 9 women who underwent laparoscopic surgery in 9 women who underwent laparoscopic surgery in first or second trimester for an adnexal massfirst or second trimester for an adnexal mass

•• Cystectomy or oophorectomy performedCystectomy or oophorectomy performed

•• Mean uterine resistance index and umbilical artery Mean uterine resistance index and umbilical artery pulsatility index were constant during surgerypulsatility index were constant during surgery

•• Fetal heart rate was normal throughout but Fetal heart rate was normal throughout but decreased during the proceduredecreased during the procedure

•• No maternal complications, no miscarriages, no No maternal complications, no miscarriages, no adverse pregnancy outcomesadverse pregnancy outcomes

–– Candiani et al, JMIG 2012Candiani et al, JMIG 2012

pulsatility index were constant during surgerypulsatility index were constant during surgery

•• Fetal heart rate was normal throughout but Fetal heart rate was normal throughout but decreased during the proceduredecreased during the procedure

•• No maternal complications, no miscarriages, no No maternal complications, no miscarriages, no adverse pregnancy outcomesadverse pregnancy outcomes

–– Candiani et al, JMIG 2012Candiani et al, JMIG 2012

•• 262 women: 174 women (66.4%) had laparotomy, 262 women: 174 women (66.4%) had laparotomy, •• 262 women: 174 women (66.4%) had laparotomy, 262 women: 174 women (66.4%) had laparotomy, ( ) p y( ) p y88 women (33.6%) had laparoscopy88 women (33.6%) had laparoscopy

•• 5 miscarriages, all within 3 weeks of surgery (3/2)5 miscarriages, all within 3 weeks of surgery (3/2)

•• Shorter mean operative time Shorter mean operative time –– 60.7 vs 69.7 min, p = 0.00260.7 vs 69.7 min, p = 0.002

•• Shorter mean hospital stayShorter mean hospital stay–– 4.7 vs 6.6 days, p < 0.0014.7 vs 6.6 days, p < 0.001

( ) p y( ) p y88 women (33.6%) had laparoscopy88 women (33.6%) had laparoscopy

•• 5 miscarriages, all within 3 weeks of surgery (3/2)5 miscarriages, all within 3 weeks of surgery (3/2)

•• Shorter mean operative time Shorter mean operative time –– 60.7 vs 69.7 min, p = 0.00260.7 vs 69.7 min, p = 0.002

•• Shorter mean hospital stayShorter mean hospital stay–– 4.7 vs 6.6 days, p < 0.0014.7 vs 6.6 days, p < 0.001

•• No differences in outcomeNo differences in outcome–– Preterm labor not significant Preterm labor not significant

on multivariate analysison multivariate analysis

•• Laparoscopy may be Laparoscopy may be preferablepreferable

•• No differences in outcomeNo differences in outcome–– Preterm labor not significant Preterm labor not significant

on multivariate analysison multivariate analysis

•• Laparoscopy may be Laparoscopy may be preferablepreferable

36

Is MIS safe in pregnancy?Is MIS safe in pregnancy?

•• Several case series report on feasibility, safety, and Several case series report on feasibility, safety, and potential benefits of MISpotential benefits of MIS

•• Cochrane database review: not enough information Cochrane database review: not enough information to make conclusions regarding MISto make conclusions regarding MIS

•• Several case series report on feasibility, safety, and Several case series report on feasibility, safety, and potential benefits of MISpotential benefits of MIS

•• Cochrane database review: not enough information Cochrane database review: not enough information to make conclusions regarding MISto make conclusions regarding MISg gg g

•• Recommend a randomized trialRecommend a randomized trial

g gg g

•• Recommend a randomized trialRecommend a randomized trial

•• Can early ovarian malignancy be Can early ovarian malignancy be adequately managed by laparoscopy?adequately managed by laparoscopy?–– ControversialControversial–– Prospective studies best way to addressProspective studies best way to address–– Only in guarded circumstances by Only in guarded circumstances by

experienced laparoscopistsexperienced laparoscopists

•• Can early ovarian malignancy be Can early ovarian malignancy be adequately managed by laparoscopy?adequately managed by laparoscopy?–– ControversialControversial–– Prospective studies best way to addressProspective studies best way to address–– Only in guarded circumstances by Only in guarded circumstances by

experienced laparoscopistsexperienced laparoscopistsexperienced laparoscopistsexperienced laparoscopists–– Never with ascitesNever with ascites–– Never with advanced diseaseNever with advanced disease–– Never if the procedure will be Never if the procedure will be

compromisedcompromised

experienced laparoscopistsexperienced laparoscopists–– Never with ascitesNever with ascites–– Never with advanced diseaseNever with advanced disease–– Never if the procedure will be Never if the procedure will be

compromisedcompromisedThank You !

37

A Gynecologic Oncologist’s Approach to

Removing Difficult Adnexal Masses

David M. Boruta MD

Massachusetts General Hospital

Consultant: Boston Scientific Corp. Inc.

• Recognize the risk of cyst rupture during adnexal surgery.

• Assess the significance of cyst rupture during adnexal surgery.

• Demonstrate minimally invasive ytechniques for removal of adnexal tumor while avoiding intraperitoneal spillage of cyst contents.

Case 1

• 28 y/o G1 at 13 weeks EGA

• 7.5 cm left ovarian mass, “probable dermoid”

44

5

Case 2

• 50 y/o G2P2

• Menopausal

• 10 cm right adnexal cystic mass on exam d l d l i l i l

6

and ultrasound, relatively simple appearing

• CA-125 200

6

38

7

Does rupture matter?

• Benign

• Malignant

88

Benign cyst rupture

• Dermoid– Pansky et al. 2010

• 128 laparoscopies, 89.8% cystectomy; 34.4% rupture

9

p

• No chemical peritonitis

• Known reproductive outcomes, 45 women– Spontaneous pregnancy: 100% in rupture and 68.9% in

non-rupture patients

9

Benign cyst rupture

• Mucinous cystadenoma– Ben-Ami et al. 2010

• 42 women, both laparoscopic and laparotomy

• Rupture rate 23 8%

10

Rupture rate 23.8%

• 7.1% recurrence– all after cystectomy with rupture

– all in same ovary

10

Malignant cyst rupture

• Vergote et al. 2001– 1545 women with stage I epithelial ovarian

cancer

– all laparotomy; inconsistent staging

11

– all laparotomy; inconsistent staging

– 8% rupture rate

– DFS worse with rupture• Preop rupture: HR 2.65 (1.53-4.56)

• Intraop rupture: HR 1.64 (1.07-2.51)

11


• Bakkum-Gomez et al. 2009:– 161 stage I epithelial ovarian cancers

– all surgically staged with laparotomy

44 7 month follow up

12

– 44.7 month follow-up• 14% recurrence, 7% death

– Rupture, positive cytology, and increased stage associated with worse DFS

12

39


– After controlling for cytology, rupture still significantly worsened DFS

– Worst survival in stage IC with positive cytology and/or surface tumor PLUS rupture

13

y gy p

– Although not statistically significant, recurrence and death in ICr (IC due to rupture alone) vs. IA/B was 13.2 vs. 5.4% and 7.9 vs. 1.4%, respectively

13


• Changes therapy:– in Bakkum-Gomez et al., chemo delivered in

43% vs. 89% of IA/B vs. IC rupture only patients

14

patients

– Recurrence:• IA- 5.4%

• ICr - 13.2%

• ICr with chemo - 12%

14


• Either:– rupture spreads tumor

• Ori fl i f i l i

15

– rupture is reflective of innately aggressive tumor

15

Risks for rupture

Cystectomy (%)

Adnexectomy (%)

Pansky et al. 2010

37.4 7.7

16

Ben-Ami et al. 2010

35.7 17.9

Smorgick et. al. 2009

29.5 7.4

Risks for ruptureLaparoscopy

(%)Laparotomy (%)

Gal et al. 1995 25 9.4

Havrilesky et al

17

Havrilesky et al. 2003

25 -

Vergote et al. 2001 - 8

Bakkum-Gomez et al. 2009

- 38

Preventative measures

• Patient selection to determine approach and procedure

• Endoscopic bagf t i l

18

– for retrieval

– for protection• Kondo et al. 2010

• “Controlled” drainage

18

40

Additional cases

• Case 3– 40 y/o G4P1 with abdominal fullness

– USN and CT show a 6 cm “fatty” left adnexal mass and a 10 x 16 x 22 cm complex cystic

19

mass and a 10 x 16 x 22 cm complex cystic mass, likely the right ovary

19 20

Additional cases

• Case 4– 31 y/o G0 with abdominal pressure

– 10+ cm complex cystic right ovarian mass, otherwise unremarkable CT scan

21

otherwise unremarkable CT scan

– CA-125 431

21

Conclusions

• Rupture of malignant ovarian cysts worsens prognosis and may prompt delivery of chemotherapy

• Rupture should be avoided when possible

22

• Rupture should be avoided when possible

• Skilled, cautious laparoscopy should continue to be standard surgical approach for adnexal surgery

22

1. Bakkum-Gamez JN, Richardson DL, Seamon LG, Aletti GD, Powless CA, Keeney GL, et al. Influence of intraoperative capsule rupture on outcomes in stage I epithelial ovarian cancer. Obstetrics and gynecology. 2009;113(1):11-7. Epub 2008/12/24.

2. Ben-Ami I, Smorgick N, Tovbin J, Fuchs N, Halperin R, Pansky M. Does intraoperative spillage of benign ovarian mucinous cystadenoma increase its recurrence rate? American journal of obstetrics and gynecology. 2010;202(2):142 e1-5. Epub 2009/12/22.

3. Gal D, Lind L, Lovecchio JL, Kohn N. Comparative study of laparoscopy vs. laparotomy for adnexal surgery: efficacy, safety, and cyst rupture. Journal of gynecologic surgery. 1995;11(3):153-8. Epub 1996/03/03.

4. Havrilesky LJ, Peterson BL, Dryden DK, Soper JT, Clarke-Pearson DL, Berchuck A. Predictors of clinical outcomes in the laparoscopic management of adnexal masses. Obstetrics and gynecology. 2003;102(2):243-51. Epub 2003/08/09.

5. Kondo W, Bourdel N, Cotte B, Tran X, Botchorishvili R, Jardon K, et al. Does prevention of intraperitoneal spillage when removing a dermoid cyst prevent granulomatous peritonitis? BJOG : an international journal of obstetrics and gynaecology. 2010;117(8):1027-30. Epub 2010/05/15.

6. Pansky M, Shade D, Moskovitch M, Halperin R, Ben-Ami I, Smorgick N. Inadvertent rupture of benign cystic teratoma does not impair future fertility. American journal of obstetrics and gynecology. 2010;203(5):442 e1-4. Epub 2010/08/27.

7. Paulsen T, Kaern J, Trope C. Improved 5-year disease-free survival for FIGO stage I epithelial ovarian cancer patients without tumor rupture during surgery. Gynecologic oncology. 2011;122(1):83-8. Epub 2011/03/26.

8. Smorgick N, Barel O, Halperin R, Schneider D, Pansky M. Laparoscopic removal of adnexal cysts: is it possible to decrease inadvertent intraoperative rupture rate? American journal of obstetrics and gynecology. 2009;200(3):237 e1-3. Epub 2009/03/04.

9. Vergote I, De Brabanter J, Fyles A, Bertelsen K, Einhorn N, Sevelda P, et al. Prognostic importance of degree of differentiation and cyst rupture in stage I invasive epithelial ovarian carcinoma. Lancet. 2001;357(9251):176-82. Epub 2001/02/24.

41

A Gynecologic Oncologist’s View of Endometriosis

R. Wendel Naumann, M.D.

Carolinas Medical Center, Levine Cancer Institute

Charlotte, NC

Disclosures

• I have no financial disclosures

22

Objectives

• Review important anatomy

–Open spaces

–Find Ureter

• Tips and tricks to remove endometriosis

3

• Tips and tricks to remove endometriosis

• Discuss potential complications

3

Laparoscopic Surgery

•Should NOT be considered “minor” surgery

• Laparoscopic surgery is more difficult!!

• Liability is high

A t l k diff t f t

4

–Anatomy looks different from open anatomy

–Complications can be subtle and often overlooked or diagnosis delayed

•Endometriosis surgery is HARDER than cancer surgery

4

Problems with Endometriosis• Adhesions

–previous surgery

–endometriosis

• Scar tissue

5

–loss of tissue planes

–normal tissue will tear over endometriosis

• Recurrence–Best if treated like a CANCER!

Principles

• Identify anatomy

• Open spaces

• Restore normal anatomy

6

• Excise all tumor!!

• Check for injury

6

42

Adhesions

7

Post Laparoscopy• POD 1

– dropped Hb to 7.4

– Advanced to regular diet

– No fever but mild abdominal pain

– Heart rate in the 120s

• POD 3

f i 3 PRBC

8

– transfusion x 3 u PRBC

– CT drainage of pelvic hematoma with some improvement

• no evidence of GI injury

• POD 4

– Still having tachycardia

– pain becomes worse and CT scan still shows fluid

Severe Adhesions

99

Direct Insertion

QuickTime™ and aYUV420 codec decompressor

Warning:The content of this video is graphic in nature and may cause

10

YUV420 codec decompressorare needed to see this picture.graphic in nature and may cause significant nausea and/or discomfort to medical personnel!

10

Trocar Insertion Injury• Baggish reported 130 bowel injuries

–63% related to trocar insertion• 77% small bowel

• 41% large bowel

Bh l t d 629 t i j i

11

• Bhoyrul reported 629 trocar injuries–29% involved bowel injury

• 73% involved small bowel

• 12% unrecognized

• 19% of deaths due to unrecognized bowel injury

Bhoyrul S, J Am Coll Surg 192:677, 2001 Baggish MS, OBG Management, 20(7):47, 2008

Bowel Injury Patterns during Laparoscopy

Small Bowel (40%)Trocar (63%)

Intraop (37%)

Large Bowel (60%)

Intraop (37%)

Dissection 56%

Energy Device 44%Bipolar 57%

Monopolar 43%

Baggish MS, J Gynecol Surg 23:83, 2007

43

Instruments of Destruction

13Baggish MS, J Gynecol Surg 23:83, 2007

Abdominal Entry

QuickTime™ and adecompressor

are needed to see this picture.

Laparoscopic Incisionsfor Severe Adhesions

5 mm

10 mm 5 mm

15

5 mmScope pointed in same direction - 3 ports!

Bowel Injury

QuickTime™ and a decompressor

are needed to see this picture.

Case #1:Post Laparoscopy

• 53 yo with extensive LOA for abdominal pain

– D/C home the same day

• POD 1 ‐ complains of abdominal pain

– stronger analgesic called in by midlevel provider

17

• POD 2 ‐ calls with pain and nausea

– given a Rx for anti‐emetics

– X‐ray shows air‐fluid levels felt to be ileus/gastroenteritis

What would you do at this point?

17

Post‐op

• POD 3 ‐ presents to the ER in septic shock with sigmoid colon injury and dies

18

44

Laparoscopy• Patients DO WELL after laparoscopy

• Be suspicious if

– Nausea and vomiting or ileus

– Tachypnea or tachycardia

– Fever

19

– Confusion

– Decrease urinary output

– Significant or worsening pain

• Litigation in these cases is more associated with failure to diagnose the injury than the injury itself

Bowel Injury

• Reasons for delay–fails to place intestinal injury at top of list

–surgical consultant delayed in making correct diagnosis

20

–ancillary diagnosis can confuse the picture• pleural effusion

• chest pain

• tachypnea

• elevated creatine


Don’t let these be Red Herrings!

20

Signs of Intestinal Injury

21Baggish MS, J Gynecol Surg 23:83, 2007

Bowel InjuryTiming of Diagnosis

22


Open the Spaces and Find the Ureter!!

23

Thank you!

24

y

24

45

References

• Bhoyrul S, J Am Coll Surg 192:677, 2001

• Baggish MS, OBG Management, 20(7):47, 2008

2525

46

CULTURAL AND LINGUISTIC COMPETENCY Governor Arnold Schwarzenegger signed into law AB 1195 (eff. 7/1/06) requiring local CME providers, such as

the AAGL, to assist in enhancing the cultural and linguistic competency of California’s physicians

(researchers and doctors without patient contact are exempt). This mandate follows the federal Civil Rights Act of 1964, Executive Order 13166 (2000) and the Dymally-Alatorre Bilingual Services Act (1973), all of which

recognize, as confirmed by the US Census Bureau, that substantial numbers of patients possess limited English proficiency (LEP).

California Business & Professions Code §2190.1(c)(3) requires a review and explanation of the laws

identified above so as to fulfill AAGL’s obligations pursuant to California law. Additional guidance is provided by the Institute for Medical Quality at http://www.imq.org

Title VI of the Civil Rights Act of 1964 prohibits recipients of federal financial assistance from

discriminating against or otherwise excluding individuals on the basis of race, color, or national origin in any of their activities. In 1974, the US Supreme Court recognized LEP individuals as potential victims of national

origin discrimination. In all situations, federal agencies are required to assess the number or proportion of LEP individuals in the eligible service population, the frequency with which they come into contact with the

program, the importance of the services, and the resources available to the recipient, including the mix of oral

and written language services. Additional details may be found in the Department of Justice Policy Guidance Document: Enforcement of Title VI of the Civil Rights Act of 1964 http://www.usdoj.gov/crt/cor/pubs.htm.

Executive Order 13166,”Improving Access to Services for Persons with Limited English

Proficiency”, signed by the President on August 11, 2000 http://www.usdoj.gov/crt/cor/13166.htm was the genesis of the Guidance Document mentioned above. The Executive Order requires all federal agencies,

including those which provide federal financial assistance, to examine the services they provide, identify any

need for services to LEP individuals, and develop and implement a system to provide those services so LEP persons can have meaningful access.

Dymally-Alatorre Bilingual Services Act (California Government Code §7290 et seq.) requires every

California state agency which either provides information to, or has contact with, the public to provide bilingual

interpreters as well as translated materials explaining those services whenever the local agency serves LEP members of a group whose numbers exceed 5% of the general population.

~

If you add staff to assist with LEP patients, confirm their translation skills, not just their language skills.

A 2007 Northern California study from Sutter Health confirmed that being bilingual does not guarantee competence as a medical interpreter. http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538.

US Population

Language Spoken at Home

English

Spanish

AsianOther

Indo-Euro

California

Language Spoken at Home

Spanish

English

OtherAsianIndo-Euro

19.7% of the US Population speaks a language other than English at home In California, this number is 42.5%

47

http://www.imq.org/

http://www.usdoj.gov/crt/cor/pubs.htm

http://www.usdoj.gov/crt/cor/13166.htm

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=2078538

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