STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function (RectoVerso)

October 30, 2015 updated by: Centre Hospitalier Universitaire de Nīmes

STARR Type Trans-anal Resection Versus Vaginal Rectocele Repair Using a Posterier Elevate Prothesis: a Randomized, Multicentric, Prospective Study on Defecatory Function

The primary objective of this study is to compare the function results between two methods for surgically repairing rectoceles: vaginal versus endo-anal surgery. Our working hypothesis is that the relatively new type of endo-anal surgery will result in better voiding function compared to the traditional vaginal surgery.

Study Overview

Study Type

Interventional

Enrollment (Actual)

4

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

      • Marseille, France
        • Hopital de la Conception
      • Montpellier, France
        • Clinique Beau Soleil
      • Strasbourg, France
        • Clinique Adassa
      • Toulouse, France
        • Hôpital Paule de Viguier, CHU de Toulouse
      • Toulouse, France
        • Hôpital Purpan, CHU de Toulouse
    • Gard
      • Nîmes, Gard, France, 30029
        • Centre Hospitalier Universitaire de Nîmes

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • patient is not under any type of guardianship
  • patient has a rectocele > 3 cm during defecography
  • patient has persistent defecatory troubles depite medical treatment (laxatives for at least 1 month) and an ODS score > 10
  • patient recieved information and signed the consent form

Exclusion Criteria:

  • patient cannot read French
  • patient has an asymptomatic rectocele
  • patient with an enterocele at rest upon defecography, with opacification of the small bowel
  • patient with non-rehabilitated anorectal asynchrony (anism)
  • patient with anal incontinence, Wexner score > 7
  • patient has a rectal lesion
  • patient has previously had rectal surgery including a colorectal anastomosis
  • patient has previously had a surgery involving disection of the rectovaginal wall, except for myorraphy of relever muscles
  • patient has previously had pelvic radiotherapy
  • anal sphincter insufficiency detected by rectomanometry
  • megarectum detected by rectomanometry and defecography
  • granule transit anomaly: > 70h
  • exteriorized rectal prolapse
  • rectovaginal fistule
  • intestinal inflammatory disease
  • anal stenosis
  • anal or rectal tumor
  • patient refuses to participate or refuses to sign consent
  • patient is enrolled in another study
  • contra indication for general or localized anesthesia
  • patient does not have social security coverage

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: STARR arm
In this group of patients, the STARR transanal stapling system is used to treat the rectocele.
The STARR transanal stapling system is used to repair a rectocele.
Active Comparator: Elevate arm
In this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele.
A posterior Elevate mesh is placed transvaginally to repair a rectocele.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence/absence of a 50% drop in the ODS score
Time Frame: 12 months
presence/absence of a 50% drop in the ODS score: constipation score defined by Altomare et al, 2008.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence/absence of prolapse recurrence
Time Frame: 6 weeks
presence/absence of prolapse recurrence: determined by prolapse staging
6 weeks
Frequency of laxative use
Time Frame: 6 weeks
6 weeks
Intervention time (min)
Time Frame: 1 day
1 day
Questionnaire PFDI 20
Time Frame: 6 weeks
6 weeks
Questionnaire PFIQ 7
Time Frame: 6 weeks
6 weeks
Questionnaire SF 36
Time Frame: 6 weeks
6 weeks
Questionnaire PISQ-12
Time Frame: 6 weeks
6 weeks
presence/absence of prolapse recurrence
Time Frame: 6 months
presence/absence of prolapse recurrence: determined by prolapse staging
6 months
presence/absence of prolapse recurrence
Time Frame: 12 months
presence/absence of prolapse recurrence: determined by prolapse staging
12 months
presence/absence of prolapse recurrence
Time Frame: 36 months
presence/absence of prolapse recurrence: determined by prolapse staging
36 months
Frequency of laxative use
Time Frame: 6 months
6 months
Frequency of laxative use
Time Frame: 12 months
12 months
Frequency of laxative use
Time Frame: 36 months
36 months
Questionnaire PFDI 20
Time Frame: 6 months
6 months
Questionnaire PFDI 20
Time Frame: 12 months
12 months
Questionnaire PFDI 20
Time Frame: 36 months
36 months
Questionnaire PFIQ 7
Time Frame: 6 months
6 months
Questionnaire PFIQ 7
Time Frame: 12 months
12 months
Questionnaire PFIQ 7
Time Frame: 36 months
36 months
Questionnaire SF 36
Time Frame: 6 months
6 months
Questionnaire SF 36
Time Frame: 12 months
12 months
Questionnaire SF 36
Time Frame: 36 months
36 months
Questionnaire PISQ-12
Time Frame: 6 months
6 months
Questionnaire PISQ-12
Time Frame: 12 months
12 months
Questionnaire PISQ-12
Time Frame: 36 months
36 months

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Renaud de Tayrac, MD PhD, Centre Hospitalier Universitaire de Nîmes

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

September 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

December 9, 2010

First Submitted That Met QC Criteria

December 9, 2010

First Posted (Estimate)

December 10, 2010

Study Record Updates

Last Update Posted (Estimate)

November 1, 2015

Last Update Submitted That Met QC Criteria

October 30, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • PHRC-I/2010/RdeT-01
  • 2010-A00665-34 (Other Identifier: Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps))

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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