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

Study Overview
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Brief Summary
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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.

Official Title
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STARR Type Trans-anal Resection Versus Vaginal Rectocele Repair Using a Posterier Elevate Prothesis: a Randomized, Multicentric, Prospective Study on Defecatory Function

Conditions
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Rectocele

Intervention / Treatment
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* Procedure: STARR rectocele repair
* Procedure: Elevate mesh rectocele repair


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STARR arm<br>In this group of patients, the STARR transanal stapling system is used to treat the rectocele. | Procedure: STARR rectocele repair<br>* The STARR transanal stapling system is used to repair a rectocele.<br>|
| Active Comparator: Elevate arm<br>In this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele. | Procedure: Elevate mesh rectocele repair<br>* A posterior Elevate mesh is placed transvaginally to repair a rectocele.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence/absence of a 50% drop in the ODS score | presence/absence of a 50% drop in the ODS score: constipation score defined by Altomare et al, 2008. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence/absence of prolapse recurrence | presence/absence of prolapse recurrence: determined by prolapse staging | 6 weeks | 
| Frequency of laxative use |  | 6 weeks | 
| Intervention time (min) |  | 1 day | 
| Questionnaire PFDI 20 |  | 6 weeks | 
| Questionnaire PFIQ 7 |  | 6 weeks | 
| Questionnaire SF 36 |  | 6 weeks | 
| Questionnaire PISQ-12 |  | 6 weeks | 
| presence/absence of prolapse recurrence | presence/absence of prolapse recurrence: determined by prolapse staging | 6 months | 
| presence/absence of prolapse recurrence | presence/absence of prolapse recurrence: determined by prolapse staging | 12 months | 
| presence/absence of prolapse recurrence | presence/absence of prolapse recurrence: determined by prolapse staging | 36 months | 
| Frequency of laxative use |  | 6 months | 
| Frequency of laxative use |  | 12 months | 
| Frequency of laxative use |  | 36 months | 
| Questionnaire PFDI 20 |  | 6 months | 
| Questionnaire PFDI 20 |  | 12 months | 
| Questionnaire PFDI 20 |  | 36 months | 
| Questionnaire PFIQ 7 |  | 6 months | 
| Questionnaire PFIQ 7 |  | 12 months | 
| Questionnaire PFIQ 7 |  | 36 months | 
| Questionnaire SF 36 |  | 6 months | 
| Questionnaire SF 36 |  | 12 months | 
| Questionnaire SF 36 |  | 36 months | 
| Questionnaire PISQ-12 |  | 6 months | 
| Questionnaire PISQ-12 |  | 12 months | 
| Questionnaire PISQ-12 |  | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectocele, Trans anal STARR resection, Transvaginal repair