Clinical trial NCT01257659: STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function
Official title: STARR Type Trans-anal Resection Versus Vaginal Rectocele Repair Using a Posterier Elevate Prothesis: a Randomized, Multicentric, Prospective Study on Defecatory Function
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Rectocele
Keywords: Rectocele
Trans anal STARR resection
Transvaginal repair
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-12-10
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: presence/absence of a 50% drop in the ODS score
timeFrame: 12 months
Secondary outcomes:
measure: presence/absence of prolapse recurrence
timeFrame: 6 weeks
measure: Frequency of laxative use
timeFrame: 6 weeks
measure: Intervention time (min)
timeFrame: 1 day
measure: Questionnaire PFDI 20
timeFrame: 6 weeks
measure: Questionnaire PFIQ 7
timeFrame: 6 weeks
measure: Questionnaire SF 36
timeFrame: 6 weeks
measure: Questionnaire PISQ-12
timeFrame: 6 weeks
measure: presence/absence of prolapse recurrence
timeFrame: 6 months
measure: presence/absence of prolapse recurrence
timeFrame: 12 months
measure: presence/absence of prolapse recurrence
timeFrame: 36 months
measure: Frequency of laxative use
timeFrame: 6 months
measure: Frequency of laxative use
timeFrame: 12 months
measure: Frequency of laxative use
timeFrame: 36 months
measure: Questionnaire PFDI 20
timeFrame: 6 months
measure: Questionnaire PFDI 20
timeFrame: 12 months
measure: Questionnaire PFDI 20
timeFrame: 36 months
measure: Questionnaire PFIQ 7
timeFrame: 6 months
measure: Questionnaire PFIQ 7
timeFrame: 12 months
measure: Questionnaire PFIQ 7
timeFrame: 36 months
measure: Questionnaire SF 36
timeFrame: 6 months
measure: Questionnaire SF 36
timeFrame: 12 months
measure: Questionnaire SF 36
timeFrame: 36 months
measure: Questionnaire PISQ-12
timeFrame: 6 months
measure: Questionnaire PISQ-12
timeFrame: 12 months
measure: Questionnaire PISQ-12
timeFrame: 36 months
Other outcomes:
Locations:
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
state: Gard
city: Marseille
country: France
facility: Hôpital de la Conception
city: Montpellier
country: France
facility: Clinique Beau Soleil
city: Strasbourg
country: France
facility: Clinique Adassa
city: Toulouse
country: France
facility: Hôpital Paule de Viguier, CHU de Toulouse
city: Toulouse
country: France
facility: Hôpital Purpan, CHU de Toulouse
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Renaud de Tayrac, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: