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

Rectocele Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05894226
• Other study ID #: 2233
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: June 2023
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 30, 2022
• Est. primary completion date: February 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Defecation Syndrome
• Rectocele

Intervention

Procedure:
• laparoscopic ventral mesh rectopexy
patients are treated by laparoscopic ventral mesh rectopexy for anterior rectocele

Locations

Country	Name	City	State
Egypt	Ahmad	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in the Wexner constipation score	improvement in constipation, if the score is decreasing this means improving	6 months
Secondary	sexual function changes	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.	6 months