Transanal vs Transvaginal Rectal Resection for Anterior Rectocele

Cairo University (CU)

Status: Enrolling

Conditions: Rectocele; Female

Treatments: Procedure: Stapled Transvaginal Rectal Resection; Procedure: Stapled Transanal Rectal Resection

Study type: Interventional

Funder types: Other

Identifiers

NCT07375147

MD-133-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

62 participants in 2 patient groups

Stapled Transanal Rectal Resection

Active Comparator group

Description:

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

Treatment:

Procedure: Stapled Transanal Rectal Resection

Stapled Transvaginal Rectal Resection

Experimental group

Description:

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

Treatment:

Procedure: Stapled Transvaginal Rectal Resection