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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Rectocele

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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STARR arm

In this group of patients, the STARR transanal stapling system is used to treat the rectocele.

Group Type EXPERIMENTAL

STARR rectocele repair

Intervention Type PROCEDURE

The STARR transanal stapling system is used to repair a rectocele.

Elevate arm

In this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele.

Group Type ACTIVE_COMPARATOR

Elevate mesh rectocele repair

Intervention Type PROCEDURE

A posterior Elevate mesh is placed transvaginally to repair a rectocele.

Interventions

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STARR rectocele repair

The STARR transanal stapling system is used to repair a rectocele.

Intervention Type PROCEDURE

Elevate mesh rectocele repair

A posterior Elevate mesh is placed transvaginally to repair a rectocele.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No