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

Not Applicable

Completed

• Conditions: Obstructive Defecation Syndrome; Rectocele
• Interventions: Procedure: laparoscopic ventral mesh rectopexy

• Registration Number: NCT05894226
• Lead Sponsor: Mansoura University

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.

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 Timeline

• Study Start: 2021-03-01
• Primary Completion: 2022-02-01
• Study Completion: 2022-08-30
• Study First Submitted: 2023-05-26
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-06
• Last Update Submitted: 2023-06-06
• Study First Posted: 2023-06-08
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
laparoscopic ventral mesh rectopexy arm	laparoscopic ventral mesh rectopexy	those who were underwent laparoscopic ventral mesh rectopexy for rectocele.

Primary Outcome Measures

Name	Time	Method
changes in the Wexner constipation score	6 months	improvement in constipation, if the score is decreasing this means improving

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ahmad; 🇪🇬 Mansoura, Egypt