RectoVerso: STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: STARR arm In this group of patients, the STARR transanal stapling system is used to treat the rectocele. |
Procedure: STARR rectocele repair
The STARR transanal stapling system is used to repair a rectocele.
|
| Active Comparator: Elevate arm In this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele. |
Procedure: Elevate mesh rectocele repair
A posterior Elevate mesh is placed transvaginally to repair a rectocele.
|
Outcome Measures
Primary Outcome Measures
- 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
- presence/absence of prolapse recurrence [6 weeks]
presence/absence of prolapse recurrence: determined by prolapse staging
- 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 [6 months]
presence/absence of prolapse recurrence: determined by prolapse staging
- presence/absence of prolapse recurrence [12 months]
presence/absence of prolapse recurrence: determined by prolapse staging
- presence/absence of prolapse recurrence [36 months]
presence/absence of prolapse recurrence: determined by prolapse staging
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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patient is not under any type of guardianship
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patient has a rectocele > 3 cm during defecography
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patient has persistent defecatory troubles depite medical treatment (laxatives for at least 1 month) and an ODS score > 10
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patient recieved information and signed the consent form
Exclusion Criteria:
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patient cannot read French
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patient has an asymptomatic rectocele
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patient with an enterocele at rest upon defecography, with opacification of the small bowel
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patient with non-rehabilitated anorectal asynchrony (anism)
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patient with anal incontinence, Wexner score > 7
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patient has a rectal lesion
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patient has previously had rectal surgery including a colorectal anastomosis
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patient has previously had a surgery involving disection of the rectovaginal wall, except for myorraphy of relever muscles
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patient has previously had pelvic radiotherapy
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anal sphincter insufficiency detected by rectomanometry
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megarectum detected by rectomanometry and defecography
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granule transit anomaly: > 70h
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exteriorized rectal prolapse
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rectovaginal fistule
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intestinal inflammatory disease
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anal stenosis
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anal or rectal tumor
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patient refuses to participate or refuses to sign consent
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patient is enrolled in another study
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contra indication for general or localized anesthesia
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patient does not have social security coverage
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 | ||
| 5 | Hôpital Paule de Viguier, CHU de Toulouse | Toulouse | France | ||
| 6 | Hôpital Purpan, CHU de Toulouse | Toulouse | France |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Nīmes
Investigators
- Principal Investigator: Renaud de Tayrac, MD PhD, Centre Hospitalier Universitaire de Nîmes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PHRC-I/2010/RdeT-01
- 2010-A00665-34