Status:
TERMINATED
STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function
Lead Sponsor:
Centre Hospitalier Universitaire de Nīmes
Conditions:
Rectocele
Eligibility:
FEMALE
18+ years
Phase:
NA
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 rel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01257659
Start Date
September 1 2011
End Date
May 1 2015
Last Update
November 2 2015
Active Locations (6)
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1
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, France, 30029
2
Hôpital de la Conception
Marseille, France
3
Clinique Beau Soleil
Montpellier, France
4
Clinique Adassa
Strasbourg, France