Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2025-12-24 @ 3:03 PM
NCT ID:
NCT01257659
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01257659
Study Brief:
Protocol Section:
NCT01257659