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

Rectocele Clinical Trial

— RectoVerso  

Official title:

STARR Type Trans-anal Resection Versus Vaginal Rectocele Repair Using a Posterier Elevate Prothesis: a Randomized, Multicentric, Prospective Study on Defecatory Function

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01257659
• Other study ID #: PHRC-I/2010/RdeT-01
• Secondary ID: 2010-A00665-34
• Status: Terminated
• Phase: N/A
• First received: December 9, 2010
• Last updated: October 30, 2015
• Start date: September 2011
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical 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 surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Rectocele

Intervention

Procedure:
• STARR rectocele repair
The STARR transanal stapling system is used to repair a rectocele.
• Elevate mesh rectocele repair
A posterior Elevate mesh is placed transvaginally to repair a rectocele.

Locations

Country	Name	City	State
France	Hôpital de la Conception	Marseille
France	Clinique Beau Soleil	Montpellier
France	Centre Hospitalier Universitaire de Nîmes	Nîmes	Gard
France	Clinique Adassa	Strasbourg
France	Hôpital Paule de Viguier, CHU de Toulouse	Toulouse
France	Hôpital Purpan, CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	presence/absence of prolapse recurrence	presence/absence of prolapse recurrence: determined by prolapse staging	6 weeks	No
Secondary	Frequency of laxative use		6 weeks	No
Secondary	Intervention time (min)		1 day	No
Secondary	Questionnaire PFDI 20		6 weeks	No
Secondary	Questionnaire PFIQ 7		6 weeks	No
Secondary	Questionnaire SF 36		6 weeks	No
Secondary	Questionnaire PISQ-12		6 weeks	No
Secondary	presence/absence of prolapse recurrence	presence/absence of prolapse recurrence: determined by prolapse staging	6 months	No
Secondary	presence/absence of prolapse recurrence	presence/absence of prolapse recurrence: determined by prolapse staging	12 months	No
Secondary	presence/absence of prolapse recurrence	presence/absence of prolapse recurrence: determined by prolapse staging	36 months	No
Secondary	Frequency of laxative use		6 months	No
Secondary	Frequency of laxative use		12 months	No
Secondary	Frequency of laxative use		36 months	No
Secondary	Questionnaire PFDI 20		6 months	No
Secondary	Questionnaire PFDI 20		12 months	No
Secondary	Questionnaire PFDI 20		36 months	No
Secondary	Questionnaire PFIQ 7		6 months	No
Secondary	Questionnaire PFIQ 7		12 months	No
Secondary	Questionnaire PFIQ 7		36 months	No
Secondary	Questionnaire SF 36		6 months	No
Secondary	Questionnaire SF 36		12 months	No
Secondary	Questionnaire SF 36		36 months	No
Secondary	Questionnaire PISQ-12		6 months	No
Secondary	Questionnaire PISQ-12		12 months	No
Secondary	Questionnaire PISQ-12		36 months	No