Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair for Anterior Rectocele.

NCT06633172 | Completed

• 1 other identifier: 11111
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effect of laparoscopic ventral mesh rectopexy versus trans vaginal repair in management of anterior rectocele in females regarding functional outcomes.

Conditions

Rectocele; Anterior Rectocele

Keywords

transvaginal repair; ventral mesh rectopexy; laparoscopic

Outcome Measures

Primary Outcomes (1)

• Improvement of constipation

  The primary outcome of the study was the absolute decline in constipation score(Cleveland clinic constipation score). This score is composed of 8 questions. Score ranges from 0 to 32. The lowest score is 0 which means no constipation, while the highest is 32 which means worsening of the constipation. So, the decline in the score means improving of the constipation.

  6 month to 1 year

Secondary Outcomes (1)

• improvement of sexual function

  6 month to 1 year

Study Arms (2)

laparoscopic ventral mesh rectopexy

ACTIVE COMPARATOR

performing laparoscopic ventral mesh rectopexy for group of patients to find out its efficacy

Procedure: laparoscopic ventral mesh rectopexy

Trans vaginal repair

ACTIVE COMPARATOR

performing trans vaginal repair for the 2nd group to find out its efficacy.

Procedure: Trans vaginal repair

Interventions

laparoscopic ventral mesh rectopexy PROCEDURE

performing ventral mesh rectopexy via laparoscopic surgery to correct the anterior rectocele.

Also known as: VMR, ventral mesh rectopexy

laparoscopic ventral mesh rectopexy

Trans vaginal repair PROCEDURE

performing repair of the rectocele through the recto vaginal septum repair.

Also known as: TVR

Trans vaginal repair

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female patients aged between 30 and 60 years, presented with symptomatic rectocele with failed conservative treatments.
• anterior rectocele larger than 3 cm in size with retention of the contrast in the rectocele on defecography.
• excessive straining, sense of incomplete evacuation, the need for digital manipulation during defecation, or dyspareunia.

You may not qualify if:

• significant urinary manifestations due to anterior vaginal wall prolapse.
• patients with recurrent rectocele
• complete external rectal prolapse
• isolated anismus
• connective tissue disease
• patients with slow-transit constipation
• fecal incontinence (FI), or abnormal thyroid function.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura university

Al Mansurah, Dakahlia Governorate, 35516, Egypt

Location

Related Publications (1)

• Sanad A, Sakr A, Elfeki H, Omar W, Thabet W, Fouda E, Abdallah E, Elbaz SA. Outcomes of laparoscopic ventral mesh rectopexy versus trans-vaginal repair in management of anterior rectocele, a randomized controlled trial. Tech Coloproctol. 2025 May 27;29(1):125. doi: 10.1007/s10151-025-03145-z.

  PMID: 40423835 DERIVED

MeSH Terms

Conditions

Rectocele

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmad Sakr, Phd

  Mansoura University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 4, 2024
• First Posted: October 9, 2024
• Study Start: April 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: April 30, 2023
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

EG (1)