- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01257659
STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function (RectoVerso)
October 30, 2015 updated by: Centre Hospitalier Universitaire de Nīmes
STARR Type Trans-anal Resection Versus Vaginal Rectocele Repair Using a Posterier Elevate Prothesis: a Randomized, Multicentric, Prospective Study on Defecatory Function
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marseille, France
- Hopital de la Conception
-
Montpellier, France
- Clinique Beau Soleil
-
Strasbourg, France
- Clinique Adassa
-
Toulouse, France
- Hôpital Paule de Viguier, CHU de Toulouse
-
Toulouse, France
- Hôpital Purpan, CHU de Toulouse
-
-
Gard
-
Nîmes, Gard, France, 30029
- Centre Hospitalier Universitaire de Nîmes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: STARR arm
In this group of patients, the STARR transanal stapling system is used to treat the rectocele.
|
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.
|
A posterior Elevate mesh is placed transvaginally to repair a rectocele.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
presence/absence of a 50% drop in the ODS score
Time Frame: 12 months
|
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
Time Frame: 6 weeks
|
presence/absence of prolapse recurrence: determined by prolapse staging
|
6 weeks
|
Frequency of laxative use
Time Frame: 6 weeks
|
6 weeks
|
|
Intervention time (min)
Time Frame: 1 day
|
1 day
|
|
Questionnaire PFDI 20
Time Frame: 6 weeks
|
6 weeks
|
|
Questionnaire PFIQ 7
Time Frame: 6 weeks
|
6 weeks
|
|
Questionnaire SF 36
Time Frame: 6 weeks
|
6 weeks
|
|
Questionnaire PISQ-12
Time Frame: 6 weeks
|
6 weeks
|
|
presence/absence of prolapse recurrence
Time Frame: 6 months
|
presence/absence of prolapse recurrence: determined by prolapse staging
|
6 months
|
presence/absence of prolapse recurrence
Time Frame: 12 months
|
presence/absence of prolapse recurrence: determined by prolapse staging
|
12 months
|
presence/absence of prolapse recurrence
Time Frame: 36 months
|
presence/absence of prolapse recurrence: determined by prolapse staging
|
36 months
|
Frequency of laxative use
Time Frame: 6 months
|
6 months
|
|
Frequency of laxative use
Time Frame: 12 months
|
12 months
|
|
Frequency of laxative use
Time Frame: 36 months
|
36 months
|
|
Questionnaire PFDI 20
Time Frame: 6 months
|
6 months
|
|
Questionnaire PFDI 20
Time Frame: 12 months
|
12 months
|
|
Questionnaire PFDI 20
Time Frame: 36 months
|
36 months
|
|
Questionnaire PFIQ 7
Time Frame: 6 months
|
6 months
|
|
Questionnaire PFIQ 7
Time Frame: 12 months
|
12 months
|
|
Questionnaire PFIQ 7
Time Frame: 36 months
|
36 months
|
|
Questionnaire SF 36
Time Frame: 6 months
|
6 months
|
|
Questionnaire SF 36
Time Frame: 12 months
|
12 months
|
|
Questionnaire SF 36
Time Frame: 36 months
|
36 months
|
|
Questionnaire PISQ-12
Time Frame: 6 months
|
6 months
|
|
Questionnaire PISQ-12
Time Frame: 12 months
|
12 months
|
|
Questionnaire PISQ-12
Time Frame: 36 months
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Renaud de Tayrac, MD PhD, Centre Hospitalier Universitaire de Nîmes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
December 9, 2010
First Submitted That Met QC Criteria
December 9, 2010
First Posted (Estimate)
December 10, 2010
Study Record Updates
Last Update Posted (Estimate)
November 1, 2015
Last Update Submitted That Met QC Criteria
October 30, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHRC-I/2010/RdeT-01
- 2010-A00665-34 (Other Identifier: Agence Française de Sécurité Sanitaire des Produits de Santé (Afssaps))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rectocele
-
Alexander KhitaryanRecruitingRectal Prolapse | Rectocele; Female | Rectocele and Incomplete Uterine Prolapse | Rectocele and Complete Uterovaginal ProlapseRussian Federation
-
University Hospital, GrenobleRecruiting
-
Ain Shams Maternity HospitalRecruitingPelvic Organ Prolapse | Rectocele; FemaleEgypt
-
University Hospital of FerraraCompletedSurgery | Rectal Prolapse | Defecation Disorder | Rectocele; FemaleItaly
-
Mansoura UniversityCompleted
-
Urogynecology Associates, IndianaUnknownRectoceleUnited States
-
Wake Forest University Health SciencesCompleted
-
Mansoura UniversityCompleted
-
Consorci Sanitari de TerrassaHospital Clinico Universitario San Cecilio; Hospital Universitari MútuaTerrassa and other collaboratorsTerminated
Clinical Trials on STARR rectocele repair
-
University of MilanCompleted
-
University Hospital, GrenobleActive, not recruitingRectal ProlapseFrance
-
Ethicon Endo-Surgery (Europe) GmbHAysgarth Statistics; Physicians World GmbHCompletedIntussusception | Gastric Outlet Obstruction | Rectocele | AnismusUnited Kingdom, France, Italy
-
University of ZurichCompletedConstipation | SurgerySwitzerland
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity of BolognaUnknownRectocele | Rectal Prolapse | Sensation of Inadequate DefecationItaly
-
University of Roma La SapienzaCompletedRectocele | Rectal Prolapse | Intussusception of Rectum
-
University Hospital, GrenobleRecruiting
-
University Hospital of FerraraCompletedSurgery | Rectal Prolapse | Defecation Disorder | Rectocele; FemaleItaly
-
Ethicon Endo-SurgeryCompletedChronic Constipation | Intussusception | Rectocele | Obstructive Defecation SyndromeUnited States
-
Adrien SchwitzguebelRecruitingAnterior Cruciate Ligament Rupture | SurgerySwitzerland