RectoceleRectoVersoNCT01257659
STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function
A study testing STARR rectocele repair and Elevate mesh rectocele repair in people with Rectocele, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectocele
- What is being tested?
- STARR rectocele repair and Elevate mesh rectocele repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 6 sitesFrance
- Study dates
- Sep 2011to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hôpital de la Conception
Marseille
Clinique Beau Soleil
Montpellier
Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard, 30029
Clinique Adassa
Strasbourg
Hôpital Paule de Viguier, CHU de Toulouse
Toulouse
Hôpital Purpan, CHU de Toulouse
Toulouse
About this study
Official title: 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.
- Conditions
- Rectocele
- Being tested
- STARR rectocele repair, Elevate mesh rectocele repair
- Keywords
- Rectocele, Trans anal STARR resection, Transvaginal repair
- Medical subject headings
- Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARR rectocele repairProcedure or surgery
The STARR transanal stapling system is used to repair a rectocele.
Elevate mesh rectocele repairProcedure or surgery
A posterior Elevate mesh is placed transvaginally to repair a rectocele.
| Study group | Role | What they receive |
|---|---|---|
| STARR arm | Experimental | In this group of patients, the STARR transanal stapling system is used to treat the rectocele. Receives: Procedure: STARR rectocele repair |
| Elevate arm | Active comparator | In this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele. Receives: Procedure: Elevate mesh rectocele repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (25)
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
Measured: 6 weeks
Frequency of laxative use
Measured: 6 weeks
Intervention time (min)
Measured: 1 day
Questionnaire PFDI 20
Measured: 6 weeks
Questionnaire PFIQ 7
Measured: 6 weeks
Questionnaire SF 36
Measured: 6 weeks
Questionnaire PISQ-12
Measured: 6 weeks
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
Measured: 6 months
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
Measured: 12 months
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
Measured: 36 months
Frequency of laxative use
Measured: 6 months
Frequency of laxative use
Measured: 12 months
Frequency of laxative use
Measured: 36 months
Questionnaire PFDI 20
Measured: 6 months
Questionnaire PFDI 20
Measured: 12 months
Questionnaire PFDI 20
Measured: 36 months
Questionnaire PFIQ 7
Measured: 6 months
Questionnaire PFIQ 7
Measured: 12 months
Questionnaire PFIQ 7
Measured: 36 months
Questionnaire SF 36
Measured: 6 months
Questionnaire SF 36
Measured: 12 months
Questionnaire SF 36
Measured: 36 months
Questionnaire PISQ-12
Measured: 6 months
Questionnaire PISQ-12
Measured: 12 months
Questionnaire PISQ-12
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startSep 2011
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Unable to find enough patients who accept randomization of surgical procedures.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RectoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Renaud de Tayrac, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257659
- Sponsor's protocol ID
- PHRC-I/2010/RdeT-01
- Other IDs
- 2010-A00665-34
- Acronym
- RectoVerso
- Status last verified
- Oct 2015
- First submitted
- 9 Dec 2010
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STARR Type Trans-anal Resection Versus Vaginal Rectocele Repair Using a Posterier Elevate Prothesis: a Randomized, Multicentric, Prospective Study on Defecatory Function
- ClinicalTrials.gov ID
- NCT01257659
- Acronym / sponsor ID
- RectoVerso / PHRC-I/2010/RdeT-01
- Conditions
- Rectocele
- Keywords
- Rectocele, Trans anal STARR resection, Transvaginal repair
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to find enough patients who accept randomization of surgical procedures.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STARR arm | Experimental | Procedure: STARR rectocele repairIn this group of patients, the STARR transanal stapling system is used to treat the rectocele. |
| Elevate arm | Active comparator | Procedure: Elevate mesh rectocele repairIn this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STARR rectocele repairThe STARR transanal stapling system is used to repair a rectocele. | Procedure or surgery | STARR arm |
| Elevate mesh rectocele repairA posterior Elevate mesh is placed transvaginally to repair a rectocele. | Procedure or surgery | Elevate arm |
Primary outcome
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.
25 secondary outcomes
presence/absence of prolapse recurrence
Time frame: 6 weeks
Frequency of laxative use
Time frame: 6 weeks
Intervention time (min)
Time frame: 1 day
Questionnaire PFDI 20
Time frame: 6 weeks
Questionnaire PFIQ 7
Time frame: 6 weeks
Questionnaire SF 36
Time frame: 6 weeks
Questionnaire PISQ-12
Time frame: 6 weeks
presence/absence of prolapse recurrence
Time frame: 6 months
presence/absence of prolapse recurrence
Time frame: 12 months
presence/absence of prolapse recurrence
Time frame: 36 months
Frequency of laxative use
Time frame: 6 months
Frequency of laxative use
Time frame: 12 months
Frequency of laxative use
Time frame: 36 months
Questionnaire PFDI 20
Time frame: 6 months
Questionnaire PFDI 20
Time frame: 12 months
Questionnaire PFDI 20
Time frame: 36 months
Questionnaire PFIQ 7
Time frame: 6 months
Questionnaire PFIQ 7
Time frame: 12 months
Questionnaire PFIQ 7
Time frame: 36 months
Questionnaire SF 36
Time frame: 6 months
Questionnaire SF 36
Time frame: 12 months
Questionnaire SF 36
Time frame: 36 months
Questionnaire PISQ-12
Time frame: 6 months
Questionnaire PISQ-12
Time frame: 12 months
Questionnaire PISQ-12
Time frame: 36 months
Results and safety
The study was stopped early (reason given: Unable to find enough patients who accept randomization of surgical procedures.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
Related trials for Rectocele
Not yet recruiting
Transverse Perineal Support With STARR for Anterior Rectocele With Excessive Perineal Descent
Rectocele, Perineal Descent
Recruiting
Transanal vs Transvaginal Rectal Resection for Anterior Rectocele
Rectocele; Female
Recruiting
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
Colorectal Disorders, Prolapse
RecruitingPhase 3
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Pelvic Floor Prolapse, Functional Constipation
Enrolling by invitationObservational study
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Vaginal Vault Prolapse, Uterine Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renaud de Tayrac, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STARR rectocele repair and Elevate mesh rectocele repair in people with Rectocele, run by Centre Hospitalier Universitaire de Nīmes at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to find enough patients who accept randomization of surgical procedures.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence/absence of a 50% drop in the ODS score (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2015; AzTrials last refreshed its copy on 31 Oct 2026.