NCT01257659

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2010

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

3.7 years

First QC Date

December 9, 2010

Last Update Submit

October 30, 2015

Conditions

Rectocele

Keywords

RectoceleTrans anal STARR resectionTransvaginal repair

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (25)

  • presence/absence of prolapse recurrence

    6 weeks

  • Frequency of laxative use

    6 weeks

  • Intervention time (min)

    1 day

  • Questionnaire PFDI 20

    6 weeks

  • Questionnaire PFIQ 7

    6 weeks

  • +20 more secondary outcomes

Study Arms (2)

STARR arm

EXPERIMENTAL

In this group of patients, the STARR transanal stapling system is used to treat the rectocele.

Procedure: STARR rectocele repair

Elevate arm

ACTIVE COMPARATOR

In this group of patients, a posterior Elevate mesh is placed transvaginally to treat the rectocele.

Procedure: Elevate mesh rectocele repair

Interventions

STARR rectocele repairPROCEDURE

The STARR transanal stapling system is used to repair a rectocele.

STARR arm
Elevate mesh rectocele repairPROCEDURE

A posterior Elevate mesh is placed transvaginally to repair a rectocele.

Elevate arm

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centre Hospitalier Universitaire de Nîmes

Nîmes, Gard, 30029, France

Location

Hôpital de la Conception

Marseille, France

Location

Clinique Beau Soleil

Montpellier, France

Location

Clinique Adassa

Strasbourg, France

Location

Hôpital Paule de Viguier, CHU de Toulouse

Toulouse, France

Location

Hôpital Purpan, CHU de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Rectocele

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Renaud de Tayrac, MD PhD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2010

First Posted

December 10, 2010

Study Start

September 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 2, 2015

Record last verified: 2015-10

Locations

FR(6)