TerminatedNCT01257659RectoVersoUpdated Nov 2, 2015

STARR Trans-anal Resection Versus Vaginal Rectocele Repair Using Elevate: Effects on Defecatory Function

An interventional study of STARR rectocele repair and Elevate mesh rectocele repair in Rectocele, sponsored by Centre Hospitalier Universitaire de Nīmes. Terminated at 6 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-02.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Not applicable, Interventional, and Treatment

Why this study was terminated

Unable to find enough patients who accept randomization of surgical procedures.

Phase: Not applicable
Study type: Interventional
Enrollment: 4
Allocation: Randomized
Ages: 18 Years and older
Sex: Female

Study 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.

Conditions studied

Rectocele

Browse trials for

Rectocele 50

Keywords

Rectocele
Trans anal STARR resection
Transvaginal repair

In context

Rectocele

50 studies on the registry are indexed under Rectocele; 9 are open to participants now.

This study's enrollment of 4 is below the median of 62 across 37 interventional studies indexed under Rectocele.

Browse Rectocele studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Browse Centre Hospitalier Universitaire de Nīmes studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: Female
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 4 participants (actual)

Study arms

Experimental
STARR arm
In this group of patients, the STARR transanal stapling system is used to treat the rectocele.
Procedure: STARR rectocele repair
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

Interventions

ProcedureSTARR rectocele repair
The STARR transanal stapling system is used to repair a rectocele.
ProcedureElevate mesh rectocele repair
A posterior Elevate mesh is placed transvaginally to repair a rectocele.

What researchers measure

Primary outcomes

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.
Time frame: 12 months

Secondary outcomes

presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
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
presence/absence of prolapse recurrence: determined by prolapse staging
Time frame: 6 months
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
Time frame: 12 months
presence/absence of prolapse recurrence
presence/absence of prolapse recurrence: determined by prolapse staging
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

Study locations

6 sites

Centre Hospitalier Universitaire de Nîmes
Nîmes, Gard 30029, France
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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01257659
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Responsible party: Sponsor
First posted: Dec 10, 2010
Start date: Sep 2011
Primary completion: May 2015
Completion: May 2015
Last update: Nov 2, 2015

Study contacts

Renaud de Tayrac, MD PhD

principal investigator · Centre Hospitalier Universitaire de Nīmes

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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