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NCT Number: NCT07375147

Transanal vs Transvaginal Rectal Resection for Anterior Rectocele

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.

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Key information

Conditions

Rectocele; Female Digestive System Diseases Gastrointestinal Diseases Hernia Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectocele

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Cairo University

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

Location status: Recruiting

Location contact

Ahmed Mohamed Abdelaal, Lecturer

CONTACT

[email protected]

01118732767

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

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

    Time frame: Up to 6 months postoperatively

    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 )

Secondary outcomes

  1. Operative time

    Time frame: During surgery

    Compare time of operation between both procedure

  2. Hospitalization period

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

    Compare how many days patients stay in hospital in both groups

  3. surgical site infection

    Time frame: Up to 6 months postoperatively

    compare surgical site infection in both groups

  4. Time for wound Healing

    Time frame: Up to 6 months postoperatively

    Time for wound Healing in both groups

  5. Postoperative bleeding

    Time frame: Up to 6 months postoperatively

    Compare Postoperative bleeding in both groups

  6. Postoperative fecal incontinence

    Time frame: Up to 6 months postoperatively

    Compare post postoperative fecal incontinence in both groups

  7. Postoperative urine retention

    Time frame: Within 48 hours postoperatively

    Compare postoperative urine retention in both groups

  8. Pain intensity

    Time frame: At day 1 and day 7 postoperatively

    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})

  9. Sexual Function in both groups

    Time frame: Up to 6 months postoperatively

    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

  10. Postoperative anal stenosis in both groups

    Time frame: Up to 6 months postoperatively

    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

  11. Postoperative rectovaginal fistula in both groups

    Time frame: Up to 6 months postoperatively

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohamed Abdelaal, Lecturer

CONTACT

[email protected]

+201118732767

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 29, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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