Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?

Surgery Clinical Trial

— Compli-STARR  

Official title:

Does the Stapled Transanal Rectal Resection (STARR Procedure) Has an Effect on Anal Compliance ?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02052063
• Other study ID #: 2013/132/HP
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2014
• Last updated: December 6, 2016
• Start date: September 2014
• Est. completion date: December 2017

Study information

• Verified date: December 2016
• Source: University Hospital, Rouen
• Contact: Valérie BRIDOUX, MD
• Phone: +3323288
• Email: valerie.bridoux[@]chu-rouen.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

The stapled transanal rectal resection (STARR) has recently been recommended for patients with obstructed defecation syndrome (ODS) caused by rectocele and rectal wall intussusception.

The aim of STARR is to correct the mechanical outlet obstruction using a stapler device for endorectal resection of the distal rectum.

This technique significantly improves constipation. However, there are several reports of new-onset faecal incontinence after STARR and urgency has been identified as the major side-effect of this procedure.

Although this technique has become an important surgical option in the treatment of obstructive defaecation syndrome, its impact on continence can be problematic and objective data about parameters that predict its result are not yet available One study evaluated the anal function after surgery in 30 patients. In this study, urgency or incontinence was complained by 26% of patients. No sonographically demonstrable sphincter fragmentations were noticed in the endoanal exam performed at the follow-up.

No significant difference was observed in anorectal manometry. Even if data are not statistically significant, resting and squeezing pressures are lower in those patients not satisfied.

Currently, anal canal pressure measurements using ano-rectal manometry are the most common means of assessment of sphincter function. Some studies have been looking at the concept of distending sphincter regions as a better measure of its performance.

The functional lumen imaging probe (FLIP) is a novel technique which has the ability to provide real-time images of the function of human gastrointestinal sphincter during distension. This distensibility technique provides an important new way of studying the anal canal and hence may have a role in testing sphincter competence in patients with disorders after STARR procedure.

Twenty-eight patients will be enrolled in this study over a period of 36 months.

Preoperative assessment will include

• clinical examination

• the Wexner Incontinence Score and the Faecal Incontinence Quality-of-Life Index (FIQL) to rate anal incontinence

• video defecography, anorectal manometry, anal ultrasound (AUS) and measure of anal sphincter distensibility using endoFLIP Follow-up evaluation will scheduled for 3 months after surgery, and will include symptom evaluation (using the same standard questionnaires for incontinence), clinical examination and investigation using anal ultrasound and endoFLIP.

If we demonstrate that this surgical technique can cause anal lesions with decreased sphincter competence, this may lead to a modification of the surgical technique especially in patients at risk of developing postoperative anal incontinence.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients >18 years old

• Patient is not under any type of guardianship

• Patient has a rectocele > 3 cm during defecography

• Patient has persistent defecatory troubles despite medical treatment (laxatives for at least 1 month)

• Patient received information and signed the consent form

• Patients having social security coverage

Exclusion Criteria:

• Patient has an asymptomatic rectocele

• Patient with an enterocele at rest upon defecography, with opacification of the small bowel

• Faecal incontinence

• Anal sphincter insufficiency detected by rectal manometry

• Patient with non-rehabilitated anorectal asynchrony

• Patient has previously had rectal surgery or pelvic radiotherapy

• Patient has a anal or rectal lesion, intestinal inflammatory disease

• Anal or rectal tumor

• Immunocompromised subjects

• Positive pregnancy test, by urine

• Psychological condition which would impair participation in the study

• Coagulation disorders

• Patients using anticoagulants

• Participation in any other device or drug study within 30 days prior to enrollment.

• Patient cannot read French

• Patient is under any type of guardianship

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Intussusception
• Rectocele
• Sphincter Ani Incontinence
• Surgery

Intervention

Device:
• stapled transanal rectal resection
transanal rectal resection using staple will be done for rectocele
• Anal compliance measure with Endoflip system
Anal compliance will be measured using Endoflip system

Locations

Country	Name	City	State
France	UH Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of anal sphincter distensibility	Comparison of anal sphincter distensibility before and 3 months after surgery with cross-sectional area and intra-balloon pressure.; The device used is Endoflip system	Month 3	Yes
Secondary	Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery	Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery	Month 3	No
Secondary	Comparison of radiological data (Anal ultrasound)	Comparison of radiological data (Anal ultrasound) before and 3 months after surgery Endo-rectal Brüel and Kjaer echographic probe will be used to compare radiological data (conventional endo-rectal echography)	Month 3	No
Secondary	Comparison of Cleveland Clinic Incontinence score (CCIS) before and 3 months after surgery	Comparison between Cleveland Clinic Incontinence score (CCIS)	Month 3	No