Transanal vs Transvaginal Rectal Resection for Anterior Rectocele

NCT07375147 | Recruiting

• 1 other identifier: MD-133-2025
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Female patients presenting with obstructed defecation syndrome due to anterior rectocele will be screened according to inclusion and exclusion criteria. Eligible patients will undergo clinical assessment and appropriate investigations including defecography. After informed consent, patients will be randomized into two groups: Stapled Transanal rectal resection or Stapled Transvaginal rectal resection. Improvement in obstructed defecation symptoms and postoperative complications will be compared between the two groups.

Conditions

Rectocele; Female

Keywords

Rectocele; Obstructed defecation; Stapled Transanal Rectal Resection; Stapled Transvaginal Rectal Resection

Outcome Measures

Primary Outcomes (1)

• Improvement in obstructed defecation symptoms in both groups using Cleveland Clinic Constipation (CCC) score

  Compare Improvement in obstructed defecation symptoms in both groups using Cleveland Clinic Constipation (CCC) score. CCC score ranges from 0 to 30. Higher scores indicate a worse outcome (more severe obstructed defecation symptoms )

  Up to 6 months postoperatively

Secondary Outcomes (11)

• Operative time

  During surgery

• Hospitalization period

  From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery

• surgical site infection

  Up to 6 months postoperatively

• Time for wound Healing

  Up to 6 months postoperatively

• Postoperative bleeding

  Up to 6 months postoperatively

Study Arms (2)

Stapled Transanal Rectal Resection

ACTIVE COMPARATOR

Patients in this group will be conducted to Stapled Transanal rectal resection for the anterior rectocele

Procedure: Stapled Transanal Rectal Resection

Stapled Transvaginal Rectal Resection

EXPERIMENTAL

patients in this group will be conducted to stapled transvaginal rectal resection for the anterior rectocele

Procedure: Stapled Transvaginal Rectal Resection

Interventions

Stapled Transanal Rectal Resection PROCEDURE

Patients were placed in the lithotomy position. Using the trans-anal approach, rectocele was done using PPH circular staplers. A circular anal dilator (CAD) was inserted into the anus and sutured into position. Three full-thickness prolene 2/0 sutures were positioned at the anterior, left anterior lateral, and right anterior lateral locations, approximately 4 cm above the dentate line. At the posterior aspect, a tongue depressor was placed into the CAD groove to protect the posterior rectal wall. After insertion of the Procedure for Prolapse and Hemorrhoids stapler (PPH stapler) into the rectum with its head open past the proximal suture, PPH stapler was progressively closed. Per vaginal examination was done To make sure the stapler did not include the vagina. The stapler was then fired to complete the anterior rectal resection.

Stapled Transanal Rectal Resection

Stapled Transvaginal Rectal Resection PROCEDURE

The patient in the lithotomy position. Anal dilatation was performed. A transverse incision was made in the mucocutaneous border of the vaginal introitus; the posterior vaginal wall was dissected and separated from the anterior rectal wall up to the posterior fornix. Dissection was extended laterally to the maximum length of the rectocele. Two Babcock clamps were applied longitudinally to the rectocele, and the stapler was fired to divide the rectocele. Partial thickness stitches were applied over the staple line using vicryl 2/0 suture to reinforce the staple line.

Stapled Transvaginal Rectal Resection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult female patients complaining of obstructed defecation syndrome with anterior rectocele ≥ 3 cm on straining with failure of conservative management.

You may not qualify if:

• Patients with Slow-transit constipation
• Patients with rectocele of \< 3 cm on straining
• Patients with complete external rectal prolapse
• Evidence of colorectal carcinoma or Inflammatory bowel disease ( IBD)
• Previous rectal surgeries
• Inability for lifestyle change postoperatively
• Previous surgeries for anterior rectocele

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, Al-Manial, Cairo, Egypt, 11451, Egypt

RECRUITING

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

• Mohamed Tamer, lecteurer

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Mohamed Abdelaal, Lecturer

CONTACT

+201118732767; drabdelaal90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 29, 2026
• Study Start: June 14, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 29, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)