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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: University Hospital, Rouen

Current Primary Outcome: Comparison of anal sphincter distensibility [ Time Frame: Month 3 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery [ Time Frame: Month 3 ]
  Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery
• Comparison of radiological data (Anal ultrasound) [ Time Frame: Month 3 ]
  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)
• Comparison of Cleveland Clinic Incontinence score (CCIS) before and 3 months after surgery [ Time Frame: Month 3 ]
  Comparison between Cleveland Clinic Incontinence score (CCIS)

Original Secondary Outcome: Same as current

Information By: University Hospital, Rouen

Dates:
Date Received: January 27, 2014
Date Started: September 2014
Date Completion: December 2017
Last Updated: December 6, 2016
Last Verified: December 2016