La NeuromodulazioneSacrale nel Trattamento

della Stipsi

Michele Schiano di VisconteColorectal Surgical Unit

Chief: M. Schiano di Visconte, M.D.

Department of Surgery – S. Maria Battuti Hospital - Conegliano

Constipationis not a sign which canbe evaluated scientifically.

It is merelya symptom !

Constipation

ü2nd most common GI symptom

ü3% of population (2 - 34%)

ü1% have intractable symptoms

Constipation

üA subjective term reported by patientswhen their bowel habit is perceived to beabnormal

üObjective criteria now exist

“ Constipation has a double meaning; a person complaining of thissymptom may mean that defaecation is difficult, that it is infrequent,or both “( Moore-Gillon Journal of the Royal Society of Medicine, 1984)

Epidemiology and Cost

• Constipation is more common in– Women– > 65 years– Poor socio-economic background

• Most common treatment is laxatives– 3 million people (USA)– > $725 million

– AGA 2000 -

Specialists

Primary care31%

~75%non-consulters

~70% female

~30%male

~25%consulters

Sonennberg, 1989

Epidemiology and Cost

Constipation: Aetiology

Aetiology

Structural Functional

Secondary (systemic)Drugs and Diet

EndocrineMetabolic

Neurological

Primary (bowel problem)

Colon or rectum

Treatment: functional constipation

Treatment focussed on underlying cause....

– Combination of softener and stimulant– High fibre for slow transit– Suppositories for evacuatory dysfunction– Colonic Irrigation

– Bowel retraining / Biofeedback– Surgery

Biofeedback

üPostureüDiaphragmatic breathingüAbdominal bracing exercisesüBalloon expulsionüSplinting

Patients are re-educated, and learnhow to co-ordinate the activity of thepelvic floor and anal sphincters

Colectomy/Proctocolectomy for constipation

üPoor resultsüHigh complication ratesüRectal and small bowel dysmotility reduces

effectiveness of colectomyüEven stoma unsatisfactory but good results

in selected few

Furthermore, we achieved unsatisfactory functional resultsas assessed by objective and validated scoring systems. Inconclusion this study demonstrates a devastating outcomeafter surgery for STC. We cannot recommendcolectomy for this indication.

Sacral Nerve StimulationShort-term sacral nerve stimulation for functional anorectaland urinary disturbances: results in 40 patients: evaluationof a new option for anorectal functional disorders

Italian Group: 40 pts.Ganio E. et Al. DCR 2001,

Conclusions: In functional boweldisorders short-term sacral nervestimulation seems to be a usefuldiagnostic tool to assess patients for aminor invasive therapy alternative toconventional surgical procedure.

Sacral Nerve Stimulation

Stimulation of S3:

“neuromodulation” effect onascending pathways, localautonomic system

ØLocally (sphincter pressures,rectal sensation)

ØDistant (gut motility)

Sacral Nerve StimulationSacral nerve stimulation is a lessinvasive and reversible procedurethat enables directneuromodulation of the pelvicfloor and hindgut. It has been usedsuccessfully in the treatment ofurologic disorders and fecalincontinence, and some of thesepatients with concurrentconstipation have also notedimproved stool frequency andrectal evacuation

Malouf AJ, World J Surg. 2002

Sacral Nerve Stimulation

Short –term effects of sacral nerve stimulation for idiopathcslow transit constipationSt Mark’s Hospital.: 8 pts.

Malouf AJ. et Al. World J. Surg., 2002

Conclusions: Further studies arerequired to identify patients who maybenefit and to assess a range ofstimulation parameters.

In conclusion, SNS is aneffective treatment for patientswith intractable constipationunresponsive to conservativetreatments. Benefit ismaintained, at least in themedium term. Furtherrandomized trial data are nowawaited.

Indications– not NICE approved

– Largest study to date, Kamm et al 2010, Gut.

– improvement in n° of defecations, straining, incomplete emptying and abdominal pain

– used in slow transit BUT NO obst defecation

– difficult to achieve complete resolution of symptoms

Is Physiologic Investigation the Key to Success ?

üHistory (diary, QoL, SF-36)üList of current medicationsüPhysical examinationü Serum chemistry, as necessaryüThyroid function tests, as necessaryüColonscopyüPancolonic transit study colon scintigraphyüAnal manometryüCinedefecographyüEMGüPsychiatric consultation (MMPI-Test)

Technique : - Multiple markers ingestion -Single or Multiple Xray of abdomen

Duration : 7 or 10 days

Abnormality : % residual markers

Segments : No evaluation of segmental colonic transit

Questions about colorectal transit time

Questions about colorectal transit time

Questions about colorectal transit time: HOW I DO

The ingestion of DIFFERENT(3 types) radiopaque markerseach day at the same time for 3sequential days.

An abdominal x-ray is taken atthe same time on the fourth dayof the study and then at 3-dayintervals (7th day, 10th day,etc)

Questions about colorectal transit time: HOW I DO

colonic transit is normalin adults if <20% of themarkers can be seen onthe x-ray at 7th day

With WMC, it eliminates the use of multiple tests todiagnose the more generalized form of dysmotility. Inaddition, WMC leads to new diagnoses and allowssignificant change in management decisions inmore than half of cases including the need forcolectomy.

wireless motility capsule The WMC or SmartPill® has sensors that measurespH, pressure, and temperature, which collectivelydetermine regional and whole gut transit times ofthe GI tract

wireless motility capsule

The capsule does not require anyradiation and the methodology has beenstandardized both for study performanceand study interpretation when comparedto other techniques.

Colonic transit time is defined as the timebetween cecal entry of capsule and its exitfrom the body

Sacral nerve stimulationfor chronic constipation

Patients : Failure of standard treatment includingbiofeedback

18 F - Duration of constipation : 9 – 35 years (median 18,9)3 M - Stool frequency : 0.5 + 1.1/week (mean)

- CCCS: 19.2 + 6.4 (mean)

11 pt.: slow transit constipation10 pt.: obstructed defaecation ( 4 pt: undergoing

surgery for ODS – S.T.A.R.R.)

Schiano di Visconte M, unpublished data

SNM for chronic constipation TEMPORARY TEST (tined lead)

21

FAILURE

3(previous starr)

DEFINTIVE IMPLANT

18

STUDY EXIT

Lack of efficay: 4Other surgical procedure: 1

Adverse Events

0

Schiano di Visconte M, unpublished data

Results:

The foramen for permanent lead implantation was based on thebest motor response during acute operative nerve testing,

________________________________________

Site of SNS : S3 16 pt. (9 on left, 7 on right)S2 3 pt. (1 on left, 2 on right)S4 1 pt

Schiano di Visconte M, unpublished data

Settings were (mean): pulse width 210 (range, 210–230) µsec, frequency 27 (range, 14–50) Hz, and amplitude 1.3 (range, 0.6–5.2) mV

Results for responder patients9 F

1 M - CCCS: 12.3 + 2.1 (mean)3 pts. was lost at follow-up

Baseline 12 m°

N° / WEEK

Results for responder patients9 F1 M - Stool frequency : 3.5 + 2.0/week (mean)

3 -

5 -

7 -

24 m° 36 m°

Schiano di Visconte M, unpublished data

baseline 12 months 24 months 24 months

Physical function 57.83 76.27 75.99 75.43

Role: physical 48.37 64.01 63.59 62.15

Bodily pain 53.93 66.24 67.14 65.14

General health 49.45 58.12 59.22 57.02

Vitality 56.17 69.43 68.63 68.13

Social function 57.46 73.37 74.07 71.27

Role: emotional 69.83 79.91 78.81 76.51

Mental health 60.12 74.21 72.21 70.21

Results for responder patients- SF-36 (mean value 10 pt. having permanent

implantation)

Schiano di Visconte M, unpublished data

FAILURES: n = 7

Pre Post P

Stool frequency : 0.4 + 1.0/week : 0.9 + 1.5/week ns

CCCS: 19.5 + 7.2 17.0 + 6.6 ns

Results:

Positive Results

Sacral nerve modulation has been shown to induce pancolonicpropagating pressure waves, even if the precise mechanicsremain undefined

The preliminary diagnostic assessment and thepathophysiological interpretation of the results require thegreatest care.

Significant differences can be found in theclinical effectiveness of SNS in differentsubsets of constipated patients, with thoseaffected by slow transit constipation beingmost responsive

Subtypes of constipation: sorting out the confusion

Prather CM, Rev Gastroenterol Disord. 2004;4 Suppl 2:S11-6.

ü 50% of patients with slow-transitconstipation have irritable bowelsyndrome,

ü 50% of patients with pelvic floordyssynergia also found to have slow transit.

Physiologic Investigation is the Key to Success

HOW TO DO the study of gastrointestinalsensory-motor function, including the complexcentral nervous system interaction ?

the basic pathophysiology of chronic constipation remains unclear.

Sacral Neurostimulationin Constipation :

It may work.

But when is it reasonable ???

Thank you ….

Colorectal Surgery Unit (Chief:: M. Schiano di Visconte)Hospital “ S. Maria dei Battuti “

CONEGLIANO (TV)