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

Surgery Clinical Trial

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

Status Recruiting

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.

Clinical Trial Description

n/a

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

• NCT number: NCT02052063
• Study type: Interventional
• Source: University Hospital, Rouen
• Contact: Valérie BRIDOUX, MD
• Phone: +3323288
• Email: valerie.bridoux@chu-rouen.fr
• Status: Recruiting
• Phase: N/A
• Start date: September 2014
• Completion date: December 2017