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

Laparoscopic Ventral Mesh Rectopexy Versus Trans-vaginal Repair in Management of Anterior Rectocele; a Randomized Controlled Trial.

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.

Study Overview

• Status: Completed
• Conditions: Rectocele; Anterior Rectocele
• Intervention / Treatment: Procedure: laparoscopic ventral mesh rectopexy; Procedure: Trans vaginal repair

Detailed Description

Rectocele is the protrusion of the anterior wall of the rectum into the vaginal lumen through the rectovaginal fascia and posterior vaginal wall. Symptomatic rectocele affects postmenopausal women and causes obstructed defecation Significant rectal emptying difficulties, straining at defecation, manually assisted defecation, the need for perineal or vaginal digitation, and local symptoms such as vaginal bulging and pelvic heaviness in 30-70% of cases have been described as symptoms of rectocele .

Constipation can be managed with dietary measures, laxatives, and biofeedback training , which can be beneficial for patients with modest symptoms. Surgical treatment is recommended if conservative treatment fails to alleviate symptoms . However, some patients may be left with constipation, fecal incontinence, incomplete bowel evacuation, or sexual dysfunction despite the correction of the anatomical defect. The selection of patients for surgical intervention for symptomatic rectocele remains a matter of debate.

There is still a controversy between abdominal approaches and the transanal, transperineal, and transvaginal approaches as the optimal surgical approach to treat complex rectocele. While the latter is preferred by gynecologists, the former has increased in popularity among colorectal surgeons, aided in part by the growing interest in minimally invasive surgery.

This study aimed to evaluate the outcome of LVMR in comparison with TVR of anterior rectocele regarding the improvement in constipation score and sexual-related quality of life, surgical outcomes and postoperative complications.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35516
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: laparoscopic ventral mesh rectopexy; performing laparoscopic ventral mesh rectopexy for group of patients to find out its efficacy	Procedure: laparoscopic ventral mesh rectopexy; performing ventral mesh rectopexy via laparoscopic surgery to correct the anterior rectocele.; Other Names: VMR; ventral mesh rectopexy
Active Comparator: Trans vaginal repair; performing trans vaginal repair for the 2nd group to find out its efficacy.	Procedure: Trans vaginal repair; performing repair of the rectocele through the recto vaginal septum repair.; Other Names: TVR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement of sexual function	improvement in sexual function in the form of Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire(PISQ- 12). PISQ-12 score is composed of 3 domains with total score of 48. It ranges from 0 to 48. The higher the score, the better the sexual outcome. Other 2ry outcomes include: Operative time in minutes, time of wound healing in days and the postoperative complication in both groups.	6 month to 1 year

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Ahmad Sakr, Phd, Mansoura University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): April 30, 2023

Study Registration Dates

• First Submitted: October 4, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Estimated): October 9, 2024

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic; ventral mesh rectopexy; transvaginal repair
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Hernia; Rectocele
• Other Study ID Numbers: 11111 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No