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:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01257659
First received: December 9, 2010
Last updated: August 8, 2014
Last verified: August 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 8, 2014
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
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on October 23, 2014