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

NCT02052063 | Completed

• 1 other identifier: 2013/132/HP
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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. 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

Keywords

rectocele; intussusception; surgery

Outcome Measures

Primary Outcomes (1)

• 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

  Month 3

Secondary Outcomes (3)

• Comparison of Faecal Incontinence Quality-of-Life Index (FIQL) before and 3 months after surgery

  Month 3

• Comparison of radiological data (Anal ultrasound)

  Month 3

• Comparison of Cleveland Clinic Incontinence score (CCIS) before and 3 months after surgery

  Month 3

Study Arms (1)

Surgery

EXPERIMENTAL

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

Interventions

stapled transanal rectal resection DEVICE

transanal rectal resection using staple will be done for rectocele

Also known as: transanal rectal resection using staple

Surgery

Anal compliance measure with Endoflip system DEVICE

Anal compliance will be measured using Endoflip system

Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

UH Rouen

Rouen, 76031, France

Location

Related Publications (1)

• Desprez C, Melchior C, Gourcerol G, Tuech JJ, Houivet E, Leroi AM, Bridoux V. Assessment of anal sphincter distensibility following the STARR procedure: a pilot study. Acta Chir Belg. 2020 Jun;120(3):198-201. doi: 10.1080/00015458.2019.1693156. Epub 2019 Nov 21.

  PMID: 31738687 RESULT

MeSH Terms

Conditions

Rectocele; Intussusception

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Intestinal Obstruction

Study Officials

• Valérie BRIDOUX, MD

  UH Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2014
• First Posted: January 31, 2014
• Study Start: September 5, 2014
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: April 16, 2026

Record last verified: 2026-04

Locations

FR (1)