STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function (RectoVerso)
This study has been terminated.
(Unable to find enough patients who accept randomization of surgical procedures.)
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01257659
First received: December 9, 2010
Last updated: March 23, 2013
Last verified: March 2013
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Purpose
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 | Intervention |
|---|---|
|
Rectocele |
Procedure: STARR rectocele repair Procedure: Elevate mesh rectocele repair |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | STARR Type Trans-anal Resection Versus Vaginal Rectocele Repair Using a Posterier Elevate Prothesis: a Randomized, Multicentric, Prospective Study on Defecatory Function |
Resource links provided by NLM:
Further study details as provided by Centre Hospitalier Universitaire de Nīmes:
Primary Outcome Measures:
- presence/absence of a 50% drop in the ODS score [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]presence/absence of prolapse recurrence: determined by prolapse staging
- Frequency of laxative use [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Intervention time (min) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- Questionnaire PFDI 20 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Questionnaire PFIQ 7 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Questionnaire SF 36 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Questionnaire PISQ-12 [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- presence/absence of prolapse recurrence [ Time Frame: 6 months ] [ Designated as safety issue: No ]presence/absence of prolapse recurrence: determined by prolapse staging
- presence/absence of prolapse recurrence [ Time Frame: 12 months ] [ Designated as safety issue: No ]presence/absence of prolapse recurrence: determined by prolapse staging
- presence/absence of prolapse recurrence [ Time Frame: 36 months ] [ Designated as safety issue: No ]presence/absence of prolapse recurrence: determined by prolapse staging
- Frequency of laxative use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Frequency of laxative use [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Frequency of laxative use [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Questionnaire PFDI 20 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Questionnaire PFDI 20 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Questionnaire PFDI 20 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Questionnaire PFIQ 7 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Questionnaire PFIQ 7 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Questionnaire PFIQ 7 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Questionnaire SF 36 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Questionnaire SF 36 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Questionnaire SF 36 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Questionnaire PISQ-12 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Questionnaire PISQ-12 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Questionnaire PISQ-12 [ Time Frame: 36 months ] [ Designated as safety issue: No ]
| Enrollment: | 4 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01257659
Locations
| France | |
| Centre Hospitalier Universitaire de Nîmes | |
| Nîmes, Gard, France, 30029 | |
| Hôpital de la Conception | |
| Marseille, France | |
| Clinique Beau Soleil | |
| Montpellier, France | |
| Clinique Adassa | |
| Strasbourg, France | |
| Hôpital Paule de Viguier, CHU de Toulouse | |
| Toulouse, France | |
| 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 |
More Information
No publications provided
| Responsible Party: | Centre Hospitalier Universitaire de Nīmes |
| ClinicalTrials.gov Identifier: | NCT01257659 History of Changes |
| Other Study ID Numbers: | PHRC-I/2010/RdeT-01, 2010-A00665-34 |
| Study First Received: | December 9, 2010 |
| Last Updated: | March 23, 2013 |
| Health Authority: | France: Committee for the Protection of Personnes France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
|
Rectocele Trans anal STARR resection Transvaginal repair |
Additional relevant MeSH terms:
|
Rectocele Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013