sunday june 3, 2007 istanbul do all minimally symptomatic men need to have their inguinal hernias...
TRANSCRIPT
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Sunday June 3, 2007 Istanbul
Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias Repaired?
Management of the Asymptomatic Inguinal Hernia
Robert J. Fitzgibbons MD, FACS
Harry E. Stuckenhoff Professor of Surgery
Creighton University School of Medicine
Omaha, Nebraska USA
Turkish Chapter of the American College of Surgeons
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Sunday June 3, 2007 Istanbul
In 2007Inguinal Hernia Repair:
Has a Low Recurrence Rate Is an Outpatient Procedure Can be Performed Under Local
Anesthesia Is Associated with an Uneventful
Recovery in Most
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Sunday June 3, 2007 Istanbul
Most North American Surgeons
Have been Taught That
The Indication for Elective Inguinal Herniorrhaphy
=
The Presence of a Hernia!
Regardless of Symptoms
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Sunday June 3, 2007 Istanbul
Annual Inguinal Herniorrhaphy Rate
US 2800 Per MillionUK 1000 Per Million
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Sunday June 3, 2007 Istanbul
So the Arguments Go Like This:
Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High
The Mortality Rate Associated with a Hernia Accident is Unacceptable
Progression is Inevitable, Incarceration and or Strangulation is Likely
Operation Becomes More Difficult the Longer it is Delayed
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Sunday June 3, 2007 Istanbul
Patient Scenario
65 Year Old Healthy Male With a Unilateral, Easily Reducible Inguinal Hernia
He has No Symptoms and Has Not Had to Alter His Lifestyle in Any Way But His Wife is Worried About His Visible Bulge
He is Retired but Physically Active
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Sunday June 3, 2007 Istanbul
Surgical Counseling
The Dreaded Complication
A Hernia AccidentStrangulation Bowel Obstruction
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Sunday June 3, 2007 Istanbul
Surgical Counseling
The Hernia will Inevitably ProgressThere Will be a Penalty to Pay in Terms
of Recurrence and Complications Because Hernias Become More Difficult to Repair the Longer They Remain Unrepaired
Don’t Wait Until Your Health Declines!
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Sunday June 3, 2007 Istanbul
Chronic Groin Pain
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Sunday June 3, 2007 Istanbul
Annals of Surgery 244(2), August 2006
Sweden
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Sunday June 3, 2007 Istanbul
Fränneby and Others. Annals of Surgery 244(2), August 2006
Sweden
Swedish Hernia Register 3000 Patients with Primary Hernia Repair
in 2000 2456 Patients (86%) Returned a postal
questionnaire 758 Patients (31%), Some Pain 144 cases (6%), Interfered with Work or
Leisure Activities
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Sunday June 3, 2007 Istanbul
So Just How Valid are These Arguments For Routine Inguinal
Herniorrhaphy?
Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High
The Mortality Rate Associated with a Hernia Accident is Unacceptable
Progression is Inevitable, Incarceration and or Strangulation is Likely
Operation Becomes More Difficult the Longer it is Delayed
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Sunday June 3, 2007 Istanbul
So Just How Valid are These Arguments For Routine Inguinal
Herniorrhaphy?
Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Too High
The Mortality Rate Associated with a Hernia The Mortality Rate Associated with a Hernia Accident is UnacceptableAccident is Unacceptable
Progression is Inevitable,Progression is Inevitable, Incarceration and or Strangulation is LikelyIncarceration and or Strangulation is Likely
Operation Becomes More Difficult the Longer it Operation Becomes More Difficult the Longer it is Delayedis Delayed
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Sunday June 3, 2007 Istanbul
Risk of a Hernia AccidentWhat is Known
Adults Short Duration Old Age Femoral Hernia Coexisting Medical
Disease
Children Young Age Male Right Sided Hernia
Rai S, Chandra SS, Smile SR.. A study of the risk of strangulation and obstruction in groin hernias. Aust N Z J Surg 1998 Sep;68(9):650-4.India, 1985-1995
Who is at Risk?
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Sunday June 3, 2007 Istanbul
Risk of a Hernia AccidentWhat is Not Known
The INCIDENCE
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Sunday June 3, 2007 Istanbul
Risk of a Hernia AccidentWhat is Not Known
What is the Problem? Surgeons are Taught That All Inguinal
Hernias Should be Repaired to Prevent Complications. Therefore No Whole Groups of Patients With Hernias Untreated Exist
Variability of Surgeon Practice Patterns Surgeon A vs. Surgeon B
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Sunday June 3, 2007 Istanbul
Therefore Only Historical Data Available
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Sunday June 3, 2007 Istanbul
2 Unique Data Bases
Paul Berger’s Truss Clinic Berger P: Résultats de ľExamen de Dix Mille
Observations de Hernies. Paris, Extrait du neuvième congres francais de chirurgie 1895,1896
Cali Colombia Neutra R, Velez A, Ferreda R, Galan R. Risk of
incarceration of inguinal hernia in Cali, Columbia. Chron Dis 1981;34:561-564.
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Sunday June 3, 2007 Istanbul
Berger’s Truss Clinic
1880 - 1884 Elective Herniorrhaphy Shunned 8633 Patients 242 Hernia Accidents
= Probability of Hernia Accident Per Year Is 0.0037
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Sunday June 3, 2007 Istanbul
Cali Colombia
One Year (1965 – 1966) Government Initiative To Aggressively Examine A Stratified Random Sample Of Its Civilian Population To Determine The Frequency Of Common Conditions Such As Inguinal Hernia
Hospital Records
= Probability Of Hernia Accident Per Year Is 0.0038
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Sunday June 3, 2007 Istanbul
Cumulative Probability of an Accident
=1 – (1 – p)e
p = probability of an accident per hernia patient per year (0.00375)
e = life expectancy* *National Center for Health Statistics: Vital statistics of the United
States, 1980. Life tables, 2(6). DHHS Publ. No. (PHS) 84-1104, 1984.National Center for Health Statistics: Vital statistics of the United States,
2001. Life tables, 52(14), 2004.
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Sunday June 3, 2007 Istanbul
The Lifetime Risk of a Hernia Accident
Males
1980
18 yr 1/5.49
72 yr 1/27.03
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Sunday June 3, 2007 Istanbul
One Hernia Accident Within Two Year Follow-up 4 Months After Randomization (0.3%)
One Additional Hernia Accident at 4 Years
Overall Accident Rate 0.0018 Events/ Patient Year
Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA
2006;295:285-292
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Sunday June 3, 2007 Istanbul
So Just How Valid are These Arguments For Routine Inguinal
Herniorrhaphy?
Prolonged Observation of an Untreated Inguinal Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Hernia Will Result in an Accident Rate which is Too HighToo High
The Mortality Rate Associated with a Hernia Accident is Unacceptable
Progression is Inevitable,Progression is Inevitable, Incarceration and or Strangulation is LikelyIncarceration and or Strangulation is Likely
Operation Becomes More Difficult the Longer it Operation Becomes More Difficult the Longer it is Delayedis Delayed
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Sunday June 3, 2007 Istanbul
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Sunday June 3, 2007 Istanbul
Operative Mortality for Patients with Obstructed Inguinal Hernias
Authors
Beller & Colp(1926)
Frankau(1931)
Guillen & Aldrete(1970)
Anderson & Ostberg(1972)
Mortality Rate
10.9%
19.7%
13.2%
13.8%
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Sunday June 3, 2007 Istanbul
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Sunday June 3, 2007 Istanbul
Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA
2006;295:285-292
No Herniorrhaphy Related Mortality
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Sunday June 3, 2007 Istanbul
So Just How Valid are These Arguments For Routine Inguinal
Herniorrhaphy?
Prolonged Observation of an Untreated Inguinal Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Hernia Will Result in an Accident Rate which is Too HighToo High
The Mortality Rate Associated with a Hernia The Mortality Rate Associated with a Hernia Accident is UnacceptableAccident is Unacceptable
Progression is Inevitable, Incarceration and or Strangulation is Likely
Operation Becomes More Difficult the Longer it Operation Becomes More Difficult the Longer it is Delayedis Delayed
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Sunday June 3, 2007 Istanbul
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Sunday June 3, 2007 Istanbul
Cumulative Probability of an Inguinal Hernia Becoming Irreducible
Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9.
30% by10 Years
N= 699
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Sunday June 3, 2007 Istanbul
But
Incarceration ≠ Strangulation
Many Men with Chronically Incarcerated Inguinal Hernias are Minimally Symptomatic
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Sunday June 3, 2007 Istanbul
Cumulative Probability of an Inguinal Hernia Becoming Irreducible
Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9.
Vs. Emergency Surgery10 patients
1 with infarcted small bowel1 with infarcted omentum
No Deaths or Serious Complication
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Sunday June 3, 2007 Istanbul
Cumulative Probability of Pain
Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9.
90% with Pain by 10 Years
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Sunday June 3, 2007 Istanbul
Cumulative Probability of Pain
Hair A, Paterson C, Wright D, Baxter JN, O'Dwyer PJ. What effect does the duration of an inguinal hernia have on patient symptoms? J Am Coll Surg. 2001 Aug;193(2):125-9.
Leisure Activities Affected in Only 29%
Only 13% of Employed Patients had to Take Time Off Work Because of Hernia-related Symptoms.
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Sunday June 3, 2007 Istanbul
Two Year Primary Outcomes:No differences in Pain or Physical function
WW 5.1% TFR3.2% , Difference 2.86%;95% Confidence Interval, -0.04% -5.72%, P=.52
WW ↑ .29 Points TFR ↑ .13% , Difference .16;95% Confidence Interval, -1.2 – 1.5
Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA
2006;295:285-292
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Sunday June 3, 2007 Istanbul
Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA
2006;295:285-292
Likelihood of a Hernia Repair in WW
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Sunday June 3, 2007 Istanbul
So Just How Valid are These Arguments For Routine
Inguinal Herniorrhaphy?
Prolonged Observation of an Untreated Inguinal Prolonged Observation of an Untreated Inguinal Hernia Will Result in an Accident Rate which is Hernia Will Result in an Accident Rate which is Too High Too High
The Mortality Rate Associated with a Hernia The Mortality Rate Associated with a Hernia Accident is UnacceptableAccident is Unacceptable
Progression is Inevitable,Progression is Inevitable, Incarceration and or Strangulation is LikelyIncarceration and or Strangulation is Likely
Operation Becomes More Difficult the Longer it is Delayed
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Sunday June 3, 2007 Istanbul
MONTHS BETWEEN RANDOMIZATION AND SURGERY
PTOTALN=3536
N=288>6
N=65
Intraoperative (%) 3(1.04) 0.00 1.00 3(.85)
Postoperative Hernia site infection Wound hematoma Scrotum hematoma Orchitis Seroma Groin neuralgia Leg neuralgia Urinary retention Urinary infection Other
5(1.74)15(5.21)11(3.82)5(1.74)2(0.69)2(0.69)1(0.35)7(2.43)0(0.00)
12(4.17)
1(1.54)6(9.23)3(4.62)0(0.00)1(1.54)0(0.00)0(0.00)0(0.00)1(1.54)2(3.08)
1.000.24310.72800.58900.4580 1.000.18410.35720.1841 1.00
6(1.70)21(5.95)14(3.97)5(1.42)3(0.85)2(0.57)1(0.28)7(1.98)1(0.28)
14(3.97)
Total 49(17.01) 14(21.54) 0.3754 63(17.85)
Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA
2006;295:285-292
PERIOPERATIVE COMPLICATIONS
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Sunday June 3, 2007 Istanbul
No Difference In Recurrence Rate
No Difference in Satisfaction with Care (97%)
Watchful Waiting vs Repair of Inguinal Hernia in Minimally Symptomatic Men: A Randomized Clinical Trial JAMA
2006;295:285-292
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Sunday June 3, 2007 Istanbul
No Longer a Valid Argument! Conventional Anterior, Non-prosthetic
Marcy Bassini Moloney Darn Shouldice McVay Cooper’s Ligament Repair Miscellaneous Repairs
Conventional Preperitoneal, Non Prosthetic
Historical Interest Bassini
Conventional Anterior, Prosthetic Lichtenstein Tension Free
Hernioplasty Mesh Plug And Patch
Conventional Preperitoneal, Prosthetic The Anterior Approach
Read-rives The Posterior Approach
Wantz /Stoppa/Rives (Giant Prosthetic Reinforcement Of The Visceral Sac)
Nyhus /Condon (iliopubic Tract Repair) Kugel/Ugahary
Combination Anterior and Preperitoneal, Prosthetic
The Bilayer Prosthetic Repair Laparoscopic Inguinal Herniorrhaphy
Transabdominal Preperitoneal (TAPP) Totally Extraperitoneal (TEP) Intraperitoneal Onlay Mesh Procedure
(IPOM)
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Sunday June 3, 2007 Istanbul
In Summary
Mortality For Strangulation is Not as Great as Once Thought
Increasing Morbidity Under Observation is Not Inevitable
There Isn't a Significant Penalty for Waiting Watchful Waiting is an Acceptable
Alternative to Routine Operation for a Minimally Symptomatic Inguinal Hernia
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Sunday June 3, 2007 Istanbul
Ann Surg 2006;244: 167–173
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Sunday June 3, 2007 Istanbul
Problems with the O’Dwyer Study
Conclusions
Repair of an Asymptomatic Inguinal Hernia: Does Not Affect the Rate of Long-term
Chronic Pain May Be Beneficial to Patients in Improving
Overall Health May Reduce Potentially Serious Morbidity
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Sunday June 3, 2007 Istanbul
Problems with the O’Dwyer Study
Recruitment Problems160 Patients (Original Design = 250)
Older Age Group55 Years or Older
More Advanced HerniaVisable bulge Required
Short Follow/up1 Year
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Sunday June 3, 2007 Istanbul
Problems with the O’Dwyer Study
Conclusions
Repair of an Asymptomatic Inguinal Hernia: Does Not Affect the Rate of Long-term
Chronic Pain
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Sunday June 3, 2007 Istanbul
Problems with the O’Dwyer Study
Conclusions
Repair of an Asymptomatic Inguinal Hernia: Does Not Affect the Rate of Long-term
Chronic Pain
(But the WW Group Did Not Have to Endure an Operation!!!)
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Sunday June 3, 2007 Istanbul
Problems with the O’Dwyer Study
Conclusions
Repair of an Asymptomatic Inguinal Hernia: Does Not Affect the Rate of Long-term Does Not Affect the Rate of Long-term
Chronic PainChronic Pain May Be Beneficial to Patients in Improving
Overall Health May Reduce Potentially Serious MorbidityMay Reduce Potentially Serious Morbidity
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Sunday June 3, 2007 Istanbul
Problems with the O’Dwyer Study
On An Intention-to-treat Analysis, There Was a Consistent Trend to Improvement of
About 5 Points in All of the SF-36 Dimensions (Except Emotional Role) in the
Operation Group Compared With the Observation Group
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Sunday June 3, 2007 Istanbul
Problems with the O’Dwyer Study
Conclusions
Repair of an Asymptomatic Inguinal Hernia: Does Not Affect the Rate of Long-term Does Not Affect the Rate of Long-term
Chronic PainChronic Pain May Be Beneficial to Patients in Improving May Be Beneficial to Patients in Improving
Overall Health Overall Health May Reduce Potentially Serious Morbidity
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Sunday June 3, 2007 Istanbul
Problems with the O’Dwyer Study
“There Were 3 Serious Adverse Events in the Observation Group : 1 Patient Had an
Acute Hernia, 1 Had a Postoperative Stroke, and 1 Had a Myocardial Infarction
and Died Postoperatively. The Patient With the Acute Hernia had It Reduced at Another
Hospital.”
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Sunday June 3, 2007 Istanbul
Problems with the O’Dwyer Study
This is a SICK Group of Patients 2 Of the Operation Patients Died Before they
could be Operated (1 of Cancer,1 Cardiac) 9 More have Already Died
The Mean Time for Operation in the “Immediate Operation Group” was 103 Days
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Sunday June 3, 2007 Istanbul
Caveats
Be Careful With ExtrapolationModerately Symptomatic Male?? Do Not Extrapolate to Woman!!
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Sunday June 3, 2007 Istanbul
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Sunday June 3, 2007 Istanbul
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Sunday June 3, 2007 Istanbul
Women
Men
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Sunday June 3, 2007 Istanbul
Do All Minimally Symptomatic Men Need to Have Their Inguinal Hernias Repaired?
Management of the Asymptomatic Inguinal Hernia
Robert J. Fitzgibbons MD, FACS
Harry E. Stuckenhoff Professor of Surgery
Creighton University School of Medicine
Omaha, Nebraska USA
Turkish Chapter of the American College of Surgeons