Rectocele; FemaleNCT07375147
Transanal vs Transvaginal Rectal Resection for Anterior Rectocele
A study testing Stapled Transanal Rectal Resection and Stapled Transvaginal Rectal Resection in people with Rectocele; Female, run by Cairo University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectocele; Female
- What is being tested?
- Stapled Transanal Rectal Resection and Stapled Transvaginal Rectal Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jun 2025to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult female patients complaining of obstructed defecation syndrome with anterior rectocele ≥ 3 cm on straining with failure of conservative management.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of medicine, Cairo University
Cairo, Al-Manial, Cairo, Egypt, 11451
Ahmed Mohamed Abdelaal, Lecturer, 01118732767, drabdelaal90@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectocele; Female
- Being tested
- Stapled Transanal Rectal Resection, Stapled Transvaginal Rectal Resection
- Keywords
- Rectocele, Obstructed defecation, Stapled Transanal Rectal Resection, Stapled Transvaginal Rectal Resection
- Medical subject headings
- Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stapled Transanal Rectal ResectionProcedure or surgery
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 ResectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Stapled Transanal Rectal Resection | Active comparator | Patients in this group will be conducted to Stapled Transanal rectal resection for the anterior rectocele Receives: Procedure: Stapled Transanal Rectal Resection |
| Stapled Transvaginal Rectal Resection | Experimental | patients in this group will be conducted to stapled transvaginal rectal resection for the anterior rectocele Receives: Procedure: Stapled Transvaginal Rectal Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 )
Measured: Up to 6 months postoperatively
Secondary outcomes (11)
Operative time
Compare time of operation between both procedure
Measured: During surgery
Hospitalization period
Compare how many days patients stay in hospital in both groups
Measured: 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
Measured: Up to 6 months postoperatively
Time for wound Healing
Time for wound Healing in both groups
Measured: Up to 6 months postoperatively
Postoperative bleeding
Compare Postoperative bleeding in both groups
Measured: Up to 6 months postoperatively
Postoperative fecal incontinence
Compare post postoperative fecal incontinence in both groups
Measured: Up to 6 months postoperatively
Postoperative urine retention
Compare postoperative urine retention in both groups
Measured: 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})
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start14 Jun 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectocele; FemaleStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Abdelaal, Cairo University
- Investigators
- Mohamed Tamer, lecteurer, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375147
- Sponsor's protocol ID
- MD-133-2025
- Status last verified
- Jun 2025
- First submitted
- 12 Jan 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Transanal Versus Transvaginal Rectal Resection for Anterior Rectocele: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07375147
- Acronym / sponsor ID
- MD-133-2025
- Conditions
- Rectocele; Female
- Keywords
- Rectocele, Obstructed defecation, Stapled Transanal Rectal Resection, Stapled Transvaginal Rectal Resection
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 14 Jun 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stapled Transanal Rectal Resection | Active comparator | Procedure: Stapled Transanal Rectal ResectionPatients in this group will be conducted to Stapled Transanal rectal resection for the anterior rectocele |
| Stapled Transvaginal Rectal Resection | Experimental | Procedure: Stapled Transvaginal Rectal Resectionpatients in this group will be conducted to stapled transvaginal rectal resection for the anterior rectocele |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult female patients complaining of obstructed defecation syndrome with anterior rectocele ≥ 3 cm on straining with failure of conservative management.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stapled Transanal Rectal ResectionPatients 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. | Procedure or surgery | Stapled Transanal Rectal Resection |
| Stapled Transvaginal Rectal ResectionThe 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. | Procedure or surgery | Stapled Transvaginal Rectal Resection |
Primary outcome
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 )
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. 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
Related trials for Rectocele; Female
Enrolling by invitationObservational study
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Vaginal Vault Prolapse, Uterine Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Tamer, lecteurer study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stapled Transanal Rectal Resection and Stapled Transvaginal Rectal Resection in people with Rectocele; Female, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Mohamed Abdelaal, Lecturer (+201118732767, drabdelaal90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in obstructed defecation symptoms in both groups using Cleveland Clinic Constipation (CCC) score (time frame: Up to 6 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026; AzTrials last refreshed its copy on 6 Nov 2026.