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

NCT ID: NCT05894226

Last Updated: 2023-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-01
• Study Completion Date: 2022-08-30

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.

Conditions

Rectocele; Obstructive Defecation Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

laparoscopic ventral mesh rectopexy arm

those who were underwent laparoscopic ventral mesh rectopexy for rectocele.

Group Type: EXPERIMENTAL

laparoscopic ventral mesh rectopexy

Intervention Type: PROCEDURE

patients are treated by laparoscopic ventral mesh rectopexy for anterior rectocele

Interventions

laparoscopic ventral mesh rectopexy

patients are treated by laparoscopic ventral mesh rectopexy for anterior rectocele

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Ahmad Sakr

consultant and lecturer of general surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ahmad

Al Mansurah, , Egypt

Countries

Egypt

Other Identifiers

2233

Identifier Type: -

Identifier Source: org_study_id