Transanal vs Transvaginal Rectal Resection for Anterior Rectocele

May 19, 2026 updated by: Ahmed Mohamed Abdelaal, Cairo University

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
    • Al-Manial, Cairo, Egypt
      • Cairo, Al-Manial, Cairo, Egypt, Egypt, 11451
        • Recruiting
        • Faculty of medicine, Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 )
Up to 6 months postoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: During surgery
Compare time of operation between both procedure
During surgery
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
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
compare surgical site infection in both groups
Up to 6 months postoperatively
Time for wound Healing
Time Frame: Up to 6 months postoperatively
Time for wound Healing in both groups
Up to 6 months postoperatively
Postoperative bleeding
Time Frame: Up to 6 months postoperatively
Compare Postoperative bleeding in both groups
Up to 6 months postoperatively
Postoperative fecal incontinence
Time Frame: Up to 6 months postoperatively
Compare post postoperative fecal incontinence in both groups
Up to 6 months postoperatively
Postoperative urine retention
Time Frame: Within 48 hours postoperatively
Compare postoperative urine retention in both groups
Within 48 hours postoperatively
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})
At day 1 and day 7 postoperatively
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
Up to 6 months postoperatively
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
Up to 6 months postoperatively
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.
Up to 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mohamed Tamer, lecteurer, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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