STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function (RectoVerso)
Primary Purpose
Rectocele
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
STARR rectocele repair
Elevate mesh rectocele repair
Sponsored by
About this trial
This is an interventional treatment trial for Rectocele focused on measuring Rectocele, Trans anal STARR resection, Transvaginal repair
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
Sites / Locations
- Centre Hospitalier Universitaire de Nîmes
- Hôpital de la Conception
- Clinique Beau Soleil
- Clinique Adassa
- Hôpital Paule de Viguier, CHU de Toulouse
- Hôpital Purpan, CHU de Toulouse
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
STARR arm
Elevate arm
Arm Description
In this group of patients, the STARR transanal stapling system is used to treat the rectocele.
In this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
Frequency of laxative use
Intervention time (min)
Questionnaire PFDI 20
Questionnaire PFIQ 7
Questionnaire SF 36
Questionnaire PISQ-12
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
Frequency of laxative use
Frequency of laxative use
Frequency of laxative use
Questionnaire PFDI 20
Questionnaire PFDI 20
Questionnaire PFDI 20
Questionnaire PFIQ 7
Questionnaire PFIQ 7
Questionnaire PFIQ 7
Questionnaire SF 36
Questionnaire SF 36
Questionnaire SF 36
Questionnaire PISQ-12
Questionnaire PISQ-12
Questionnaire PISQ-12
Full Information
NCT ID
NCT01257659
First Posted
December 9, 2010
Last Updated
October 30, 2015
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT01257659
Brief Title
STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function
Acronym
RectoVerso
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
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Unable to find enough patients who accept randomization of surgical procedures.
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectocele
Keywords
Rectocele, Trans anal STARR resection, Transvaginal repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
STARR arm
Arm Type
Experimental
Arm Description
In this group of patients, the STARR transanal stapling system is used to treat the rectocele.
Arm Title
Elevate arm
Arm Type
Active Comparator
Arm Description
In this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele.
Intervention Type
Procedure
Intervention Name(s)
STARR rectocele repair
Intervention Description
The STARR transanal stapling system is used to repair a rectocele.
Intervention Type
Procedure
Intervention Name(s)
Elevate mesh rectocele repair
Intervention Description
A posterior Elevate mesh is placed transvaginally to repair a rectocele.
Primary Outcome Measure Information:
Title
presence/absence of a 50% drop in the ODS score
Description
presence/absence of a 50% drop in the ODS score: constipation score defined by Altomare et al, 2008.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
presence/absence of prolapse recurrence
Description
presence/absence of prolapse recurrence: determined by prolapse staging
Time Frame
6 weeks
Title
Frequency of laxative use
Time Frame
6 weeks
Title
Intervention time (min)
Time Frame
1 day
Title
Questionnaire PFDI 20
Time Frame
6 weeks
Title
Questionnaire PFIQ 7
Time Frame
6 weeks
Title
Questionnaire SF 36
Time Frame
6 weeks
Title
Questionnaire PISQ-12
Time Frame
6 weeks
Title
presence/absence of prolapse recurrence
Description
presence/absence of prolapse recurrence: determined by prolapse staging
Time Frame
6 months
Title
presence/absence of prolapse recurrence
Description
presence/absence of prolapse recurrence: determined by prolapse staging
Time Frame
12 months
Title
presence/absence of prolapse recurrence
Description
presence/absence of prolapse recurrence: determined by prolapse staging
Time Frame
36 months
Title
Frequency of laxative use
Time Frame
6 months
Title
Frequency of laxative use
Time Frame
12 months
Title
Frequency of laxative use
Time Frame
36 months
Title
Questionnaire PFDI 20
Time Frame
6 months
Title
Questionnaire PFDI 20
Time Frame
12 months
Title
Questionnaire PFDI 20
Time Frame
36 months
Title
Questionnaire PFIQ 7
Time Frame
6 months
Title
Questionnaire PFIQ 7
Time Frame
12 months
Title
Questionnaire PFIQ 7
Time Frame
36 months
Title
Questionnaire SF 36
Time Frame
6 months
Title
Questionnaire SF 36
Time Frame
12 months
Title
Questionnaire SF 36
Time Frame
36 months
Title
Questionnaire PISQ-12
Time Frame
6 months
Title
Questionnaire PISQ-12
Time Frame
12 months
Title
Questionnaire PISQ-12
Time Frame
36 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renaud de Tayrac, MD PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Nîmes
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Nîmes
City
Nîmes
State/Province
Gard
ZIP/Postal Code
30029
Country
France
Facility Name
Hôpital de la Conception
City
Marseille
Country
France
Facility Name
Clinique Beau Soleil
City
Montpellier
Country
France
Facility Name
Clinique Adassa
City
Strasbourg
Country
France
Facility Name
Hôpital Paule de Viguier, CHU de Toulouse
City
Toulouse
Country
France
Facility Name
Hôpital Purpan, CHU de Toulouse
City
Toulouse
Country
France
12. IPD Sharing Statement
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STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function
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