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

April 13, 2026 updated by: University Hospital, Rouen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Rouen, France, 76031
        • UH Rouen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Surgery
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
transanal rectal resection using staple will be done for rectocele
Other Names:
  • transanal rectal resection using staple
Device: Anal compliance measure with Endoflip system
Anal compliance will be measured using Endoflip system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of anal sphincter distensibility
Time Frame: Month 3

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Month 3
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)
Month 3
Comparison of Cleveland Clinic Incontinence score (CCIS) before and 3 months after surgery
Time Frame: Month 3
Comparison between Cleveland Clinic Incontinence score (CCIS)
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Investigators

  • Principal Investigator: Valérie BRIDOUX, MD, UH Rouen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2014

Primary Completion (Actual)

September 5, 2018

Study Completion (Actual)

September 5, 2018

Study Registration Dates

First Submitted

January 27, 2014

First Submitted That Met QC Criteria

January 30, 2014

First Posted (Estimated)

January 31, 2014

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013/132/HP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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