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

Not Applicable

Terminated

• Conditions: Rectocele

• 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

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 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
Questionnaire PFIQ 7	36 months

Trial Locations

Locations (6)

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

Hôpital de la Conception; 🇫🇷 Marseille, 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