Transanal vs Transvaginal Rectal Resection for Anterior Rectocele

Official title

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

Overview

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.

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.

Interventions

• 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
• 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 ov

Primary outcome measures

• Improvement in obstructed defecation symptoms in both groups using Cleveland Clinic Constipation (CCC) score [Time frame: Up to 6 months postoperatively]

Secondary outcome measures (11)

• Operative time [Time frame: During surgery]
• Hospitalization period [Time frame: From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery]
• surgical site infection [Time frame: Up to 6 months postoperatively]
• Time for wound Healing [Time frame: Up to 6 months postoperatively]
• Postoperative bleeding [Time frame: Up to 6 months postoperatively]
• Postoperative fecal incontinence [Time frame: Up to 6 months postoperatively]
• Postoperative urine retention [Time frame: Within 48 hours postoperatively]
• Pain intensity [Time frame: At day 1 and day 7 postoperatively]
• Sexual Function in both groups [Time frame: Up to 6 months postoperatively]
• Postoperative anal stenosis in both groups [Time frame: Up to 6 months postoperatively]
• Postoperative rectovaginal fistula in both groups [Time frame: Up to 6 months postoperatively]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of medicine, Cairo University — Cairo

Identifiers

NCT: NCT07375147 · MD-133-2025

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗