Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele

Sponsor

Mansoura University (Other)

Overall Status

Completed

CT.gov ID

NCT05894226

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The ideal surgical strategy for treating complex rectocele remains a topic for debate, with the transanal, transperineal, and transvaginal approach and the abdominal approach being at conflict with one another. While the transvaginal repair is more popular among gynecologists, the trans abdominal approach has become increasingly common among colorectal surgeons, in part due to the rising demand for minimally invasive surgery.

Condition or Disease	Intervention/Treatment	Phase
Rectocele Obstructive Defecation Syndrome	Procedure: laparoscopic ventral mesh rectopexy	N/A

Detailed Description

For the treatment of rectoceles and ODS in general, the laparoscopic method has recently come to light as a promising alternative.

Laparoscopic ventral mesh rectopexy (LVMR) was originally described for the management of rectal prolapse. However, It was also recommended with encouraging results for the treatment of large symptomatic rectocele.

The present study aims to evaluate the safety and efficacy of LVMR for complex rectocele.

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Functional and Sexual Outcomes After Laparoscopic Ventral Mesh Rectopexy for Complex Rectocele

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Feb 1, 2022

Actual Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: laparoscopic ventral mesh rectopexy arm those who were underwent laparoscopic ventral mesh rectopexy for rectocele.	Procedure: laparoscopic ventral mesh rectopexy patients are treated by laparoscopic ventral mesh rectopexy for anterior rectocele

Arm

Intervention/Treatment

Experimental: laparoscopic ventral mesh rectopexy arm

those who were underwent laparoscopic ventral mesh rectopexy for rectocele.

Procedure: laparoscopic ventral mesh rectopexy

patients are treated by laparoscopic ventral mesh rectopexy for anterior rectocele

Outcome Measures

Primary Outcome Measures

changes in the Wexner constipation score [6 months]
improvement in constipation, if the score is decreasing this means improving

Secondary Outcome Measures

sexual function changes [6 months]
changes in the sexual function score post operative (Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire score(PISQ-12). The lower the score the better the function.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

multiparous female patients.
aged between 30 and 60 years
who were diagnosed with complex anterior rectocele- more than 3cm after failed medical treatment- with history of either vaginal delivery or caesarian section.
complex rectocele was one having any of the following features: size > 3 cm in diameter, associated enterocoele or internal rectal prolapse

Exclusion Criteria:

paradoxical contraction of puborectalis muscle (anismus),
complete external rectal prolapse
fecal incontinence
other benign anal conditions
those who are unfit for surgery due to associated severe co-morbidities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ahmad	Mansoura		Egypt

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmad Sakr, consultant and lecturer of general surgery, Mansoura University

ClinicalTrials.gov Identifier:

NCT05894226

Other Study ID Numbers:

2233

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ahmad Sakr, consultant and lecturer of general surgery, Mansoura University

Anterior rectocele

laparoscopic ventral mesh rectopexy

Additional relevant MeSH terms:

Rectocele

Study Results

No Results Posted as of Jun 8, 2023