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

Not Applicable

Terminated

• Conditions: Rectocele
• Interventions: Procedure: STARR rectocele repair; Procedure: Elevate mesh rectocele repair

• Registration Number: NCT01257659
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-12-09
• Study First Submitted QC: 2010-12-09
• Study First Posted: 2010-12-10
• Study Start: 2011-09
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-30
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STARR arm	STARR rectocele repair	In this group of patients, the STARR transanal stapling system is used to treat the rectocele.
Elevate arm	Elevate mesh rectocele repair	In this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Hôpital de la Conception; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes, Gard, France

Clinique Beau Soleil; 🇫🇷 Montpellier, France

Clinique Adassa; 🇫🇷 Strasbourg, France

Hôpital Paule de Viguier, CHU de Toulouse; 🇫🇷 Toulouse, France

Hôpital Purpan, CHU de Toulouse; 🇫🇷 Toulouse, France