Transanal vs Transvaginal Rectal Resection for Anterior Rectocele

Outcomes of Transanal Versus Transvaginal Rectal Resection for Anterior Rectocele: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Rectocele; Female
• Intervention / Treatment: Procedure: Stapled Transanal Rectal Resection; Procedure: Stapled Transvaginal Rectal Resection

Detailed Description

This is a randomized controlled trial aims to compare the clinical outcomes of Stapled Transanal versus Stapled Transvaginal rectal resection in female patients with obstructed defecation syndrome (ODS) caused by anterior rectocele.

Female patients presenting to the outpatient colorectal clinic with symptoms of obstructed defecation syndrome will be screened for eligibility according to predefined inclusion and exclusion criteria. All eligible patients will receive a detailed explanation of the study objectives, procedures, potential benefits, and risks. Written informed consent will be obtained prior to enrollment.

A comprehensive preoperative evaluation will be performed for all participants, including detailed medical history, physical and anorectal examination, and appropriate investigations including defecography to confirm the diagnosis and assess the severity of rectocele.

Enrolled patients will be randomly assigned in a 1:1 ratio into one of two intervention groups. Group A will undergo stapled Transanal rectal resection, while Group B will undergo stapled transvaginal rectal resection. All surgical procedures will be performed by experienced colorectal surgeons.

Primary outcome measures will include improvement in obstructed defecation symptoms as assessed by Cleveland Clinic Constipation (CCC) score. Secondary outcomes will include length of hospital stay, operative time, postoperative pain score, postoperative continence state, Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and postoperative complications.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed Mohamed Abdelaal, Lecturer; Phone Number: +201118732767; Email: drabdelaal90@gmail.com

Study Locations

• Egypt
  • Al-Manial, Cairo, Egypt
    • Cairo, Al-Manial, Cairo, Egypt, Egypt, 11451
      • Recruiting
      • Faculty of medicine, Cairo University
      • Contact: Ahmed Mohamed Abdelaal, Lecturer; Phone Number: 01118732767; Email: drabdelaal90@gmail.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stapled Transanal Rectal Resection; Patients in this group will be conducted to Stapled Transanal rectal resection for the anterior rectocele	Procedure: Stapled Transanal Rectal Resection; 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.
Experimental: Stapled Transvaginal Rectal Resection; patients in this group will be conducted to stapled transvaginal rectal resection for the anterior rectocele	Procedure: Stapled Transvaginal Rectal Resection; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	Compare time of operation between both procedure	During surgery
Hospitalization period	Compare how many days patients stay in hospital in both groups	From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery
surgical site infection	compare surgical site infection in both groups	Up to 6 months postoperatively
Time for wound Healing	Time for wound Healing in both groups	Up to 6 months postoperatively
Postoperative bleeding	Compare Postoperative bleeding in both groups	Up to 6 months postoperatively
Postoperative fecal incontinence	Compare post postoperative fecal incontinence in both groups	Up to 6 months postoperatively
Postoperative urine retention	Compare postoperative urine retention in both groups	Within 48 hours postoperatively
Pain intensity	Compare Pain intensity measured using Visual Analogue Scale between both groups (Visual Analogue Scale for Pain: ranges from 0 to 10 . Higher scores indicate a worse outcome {greater pain intensity})	At day 1 and day 7 postoperatively
Sexual Function in both groups	Compare sexual function in both groups using Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ- 12). PISQ-12 score ranges from 0 to 48. Higher scores indicate better sexual function	Up to 6 months postoperatively
Postoperative anal stenosis in both groups	Postoperative anal stenosis will be assessed by digital rectal examination and graded clinically as follows: Mild: anal canal admits a well lubricated index finger.; Moderate: Forceful dilatation required to admit a well lubricated index finger.; Severe: Little finger cannot be admitted without forceful dilatation	Up to 6 months postoperatively
Postoperative rectovaginal fistula in both groups	Postoperative rectovaginal fistula will be assessed using the following methods: History: Passage of flatus or stool from the vagina.; Clinical examination: Digital rectal examination and per vaginal examination to detect induration or fistula opening.; MRI of the pelvis: Performed if fistula is suspected based on history or clinical examination to confirm the diagnosis.	Up to 6 months postoperatively

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Mohamed Tamer, lecteurer, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 21, 2026
• First Posted (Actual): January 29, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Rectocele; Obstructed defecation; Stapled Transanal Rectal Resection; Stapled Transvaginal Rectal Resection
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Hernia; Pathological Conditions, Signs and Symptoms; Rectocele
• Other Study ID Numbers: MD-133-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared because this is a small surgical trial with a limited number of participants, and sharing raw data could lead to identification of participants

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No