An interventional study of stapled transanal rectal resection and Anal compliance measure with Endoflip system in Rectocele, Intussusception and Surgery, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-04-16.
Sponsored by University Hospital, Rouen · Not applicable, Interventional, and Prevention
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
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.
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's enrollment of 9 is below the median of 62 across 37 interventional studies indexed under Rectocele.
Browse Rectocele studies →University Hospital, Rouen is the lead sponsor of 418 studies on the registry; 106 are open to participants now.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient who undergone stapled transanal rectal resection for rectocele. Anal compliance will be evaluated before and starting the surgery using endoflip system
Device: stapled transanal rectal resection · Device: Anal compliance measure with Endoflip system
transanal rectal resection using staple will be done for rectocele
Also known as: transanal rectal resection using staple
Anal compliance will be measured using Endoflip system
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
Time frame: Month 3
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
Time frame: Month 3
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)
Time frame: Month 3
Comparison of Cleveland Clinic Incontinence score (CCIS) before and 3 months after surgery
Comparison between Cleveland Clinic Incontinence score (CCIS)
Time frame: Month 3
Ran from Sep 2014 to primary completion in Sep 2018, 48 months.
Of 16 interventional studies with no phase under Rectocele, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 38. This study's 48 months is above that.
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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