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

NCT ID: NCT06633172

Last Updated: 2024-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2023-04-30

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.

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.

Conditions

Rectocele; Anterior Rectocele

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

laparoscopic ventral mesh rectopexy

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

Group Type: ACTIVE_COMPARATOR

laparoscopic ventral mesh rectopexy

Intervention Type: PROCEDURE

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

Trans vaginal repair

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

Group Type: ACTIVE_COMPARATOR

Trans vaginal repair

Intervention Type: PROCEDURE

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

Interventions

laparoscopic ventral mesh rectopexy

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

Intervention Type: PROCEDURE

Trans vaginal repair

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

Intervention Type: PROCEDURE

Other Intervention Names

VMR; ventral mesh rectopexy; TVR

Eligibility Criteria

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.

• 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

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmad Sakr, Phd

Role: PRINCIPAL_INVESTIGATOR

Mansoura University Hospital

Locations

Mansoura university

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 40423835 (View on PubMed)

Other Identifiers

11111

Identifier Type: -

Identifier Source: org_study_id