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

Centre Hospitalier Universitaire de Nīmes

Status: Terminated

Conditions: Rectocele

Treatments: Procedure: STARR rectocele repair; Procedure: Elevate mesh rectocele repair

Study type: Interventional

Funder types: Other

Identifiers

NCT01257659

2010-A00665-34 (Other Identifier)

PHRC-I/2010/RdeT-01

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 2 patient groups

STARR arm

Experimental group

Description:

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

Treatment:

Procedure: STARR rectocele repair

Elevate arm

Active Comparator group

Description:

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

Treatment:

Procedure: Elevate mesh rectocele repair