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

NCT02052063 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-04-16

No results posted yet for this study

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.

Conditions

  • Rectocele
  • Intussusception
  • Surgery
  • Sphincter Ani Incontinence

Interventions

DEVICE

stapled transanal rectal resection

transanal rectal resection using staple will be done for rectocele

DEVICE

Anal compliance measure with Endoflip system

Anal compliance will be measured using Endoflip system

Sponsors & Collaborators

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Valérie BRIDOUX, MD · UH Rouen

Study Design

Allocation
NA
Purpose
PREVENTION
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-05
Primary Completion
2018-09-05
Completion
2018-09-05

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02052063 on ClinicalTrials.gov