RectoceleNCT07777146
Transverse Perineal Support With STARR for Anterior Rectocele With Excessive Perineal Descent
A study testing STARR Procedure and STARR combined with transverse perineal support procedure in people with Rectocele and Perineal Descent, run by Cairo University at 1 site in Egypt.
Trial summary
This prospective randomized controlled trial will include adult patients with ODS, anterior rectocele ≥3 cm, and excessive perineal descent following failure of conservative treatment. Patients will be randomized 1:1 to STARR alone or STARR combined with transverse perineal support procedure using polypropylene mesh. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectocele, Perineal Descent
- What is being tested?
- STARR Procedure and STARR combined with transverse perineal support procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2026to Jan 2028
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients complaining of obstructed defecation syndrome with anterior rectocele ≥ 3 cm associated with excessive perineal descent with failure of conservative management.
Who cannot join
- Patients with Slow-transit constipation
- Patients with anterior rectocele of < 3 cm
- Patients with complete external rectal prolapse
- Evidence of colorectal carcinoma or Inflammatory bowel disease ( IBD)
- Inability for lifestyle change postoperatively
- Patients with fecal incontinence
- 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
Faculty of medicine, Cairo University
Cairo, Al-Manial, Cairo, Egypt, Egypt, 11451
About this study
Official title: Effect of Adding Transverse Perineal Support to Stapled Transanal Rectal Resection for Anterior Rectocele With Excessive Perineal Descent: A Randomized Controlled Trial
This prospective randomized controlled trial will include adult patients with ODS, anterior rectocele ≥3 cm, and excessive perineal descent following failure of conservative treatment.
Patients will be randomized 1:1 to STARR alone or STARR combined with transverse perineal support procedure using polypropylene mesh. The primary outcome will be Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups. Secondary outcomes will include operative time, postoperative pain, surgical complications, surgical site infection, and sexual function assessed using the PISQ-12. Patients will be followed up twice during the first postoperative week, weekly during the first month, and monthly thereafter.
Read the detailed description
This will be a prospective, randomized controlled trial conducted at Kasr Al-Ainy Hospitals, Cairo University, including adult patients of either sex with obstructed defecation syndrome (ODS) associated with rectocele, and excessive perineal descent. Eligible patients must have anterior rectocele ≥3 cm, excessive perineal descent, and failure of conservative treatment. Patients with Slow-transit constipation, anterior rectocele of < 3 cm, complete external rectal prolapse, evidence of colorectal carcinoma or Inflammatory bowel disease ( IBD), Patients with fecal incontinence, Inability for lifestyle change postoperatively, or previous surgeries for anterior rectocele will be excluded.
Following informed written consent, Eligible participants will be randomized in a 1:1 ratio using computer-generated randomization, with allocation concealment through sequentially numbered, opaque, sealed envelopes.
Patients will be allocated to either Group A (STARR alone) or Group B (STARR combined with transverse perineal support using non-absorbable polypropylene mesh). Postoperative assessment will include operative time, pain using the visual analogue scale, and postoperative complications.
Patients will be followed-up twice weekly in the first postoperative week, weekly during the first month, and monthly thereafter. The primary outcome will be Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups. Secondary outcomes will include operative time, postoperative pain, surgical site infection, sexual function assessed by Pelvic Organ Prolapse/Urinary incontinence sexual questionnaire (PISQ-12), and postoperative complications.
- Conditions
- Rectocele, Perineal Descent
- Being tested
- STARR Procedure, STARR combined with transverse perineal support procedure
- Keywords
- rectocele, Perineal Descent, Transverse Perineal Support
- Medical subject headings
- Rectocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARR ProcedureProcedure or surgery
The STARR procedure will be performed using PPH circular stapler to achieve trans-anal full-thickness resection of the rectocele
STARR combined with transverse perineal support procedureProcedure or surgery
Transverse perineal support procedure will be added to STARR procedure. it will be done using a non-absorbable polypropylene mesh to reinforce the perineal body and correct excessive perineal descent.
| Study group | Role | What they receive |
|---|---|---|
| STARR procedure | Active comparator | STARR will be done using PPH circular stapler to achieve trans-anal full-thickness resection of the rectocele Receives: Procedure: STARR Procedure |
| STARR combined with transverse perineal support procedure | Experimental | Transverse perineal support procedure will be added to the STARR procedure. Transverse perineal support procedure will be done using a non-absorbable polypropylene mesh to reinforce the perineal body and correct excessive perineal descent. Receives: Procedure: STARR combined with transverse perineal support procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups.
Compare Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups. Obstructed Defecation Syndrome score (ODS-S; Renzi score) ranges from 0 to 20. Higher scores indicate a worse outcome (more severe obstructed defecation symptoms )
Measured: Up to 6 months postoperatively
Secondary outcomes (6)
Operative time
Compare time of operation between both procedure
Measured: During surgery
Number of participants with surgical site infection
compare surgical site infection in both groups (surgical site infection: infection at or near a surgical incision within 30 days post-surgery, marked by redness, swelling, or pus.)
Measured: Up to 6 months postoperatively
Postoperative urine retention
Compare incidence of postoperative urine retention in both groups. (Postoperative urinary retention: inability to void spontaneously after surgery with a bladder volume ≥500 mL on bladder ultrasound).
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: Up to 6 months 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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start2 Sep 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RectoceleStudies 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
- 64 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
- Haitham M.Azmy Basiouny, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777146
- Sponsor's protocol ID
- MD-168-2026
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 26 Aug 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 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Transverse Perineal Support to Stapled Transanal Rectal Resection for Anterior Rectocele With Excessive Perineal Descent: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07777146
- Acronym / sponsor ID
- MD-168-2026
- Conditions
- Rectocele, Perineal Descent
- Keywords
- rectocele, Perineal Descent, Transverse Perineal Support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Sep 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 20 Aug 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.
This prospective randomized controlled trial will include adult patients with ODS, anterior rectocele ≥3 cm, and excessive perineal descent following failure of conservative treatment.
Patients will be randomized 1:1 to STARR alone or STARR combined with transverse perineal support procedure using polypropylene mesh. The primary outcome will be Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups. Secondary outcomes will include operative time, postoperative pain, surgical complications, surgical site infection, and sexual function assessed using the PISQ-12. Patients will be followed up twice during the first postoperative week, weekly during the first month, and monthly thereafter.
Detailed description
This will be a prospective, randomized controlled trial conducted at Kasr Al-Ainy Hospitals, Cairo University, including adult patients of either sex with obstructed defecation syndrome (ODS) associated with rectocele, and excessive perineal descent. Eligible patients must have anterior rectocele ≥3 cm, excessive perineal descent, and failure of conservative treatment. Patients with Slow-transit constipation, anterior rectocele of < 3 cm, complete external rectal prolapse, evidence of colorectal carcinoma or Inflammatory bowel disease ( IBD), Patients with fecal incontinence, Inability for lifestyle change postoperatively, or previous surgeries for anterior rectocele will be excluded.
Following informed written consent, Eligible participants will be randomized in a 1:1 ratio using computer-generated randomization, with allocation concealment through sequentially numbered, opaque, sealed envelopes.
Patients will be allocated to either Group A (STARR alone) or Group B (STARR combined with transverse perineal support using non-absorbable polypropylene mesh). Postoperative assessment will include operative time, pain using the visual analogue scale, and postoperative complications.
Patients will be followed-up twice weekly in the first postoperative week, weekly during the first month, and monthly thereafter. The primary outcome will be Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups. Secondary outcomes will include operative time, postoperative pain, surgical site infection, sexual function assessed by 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 |
|---|---|---|
| STARR procedure | Active comparator | Procedure: STARR ProcedureSTARR will be done using PPH circular stapler to achieve trans-anal full-thickness resection of the rectocele |
| STARR combined with transverse perineal support procedure | Experimental | Procedure: STARR combined with transverse perineal support procedureTransverse perineal support procedure will be added to the STARR procedure. Transverse perineal support procedure will be done using a non-absorbable polypropylene mesh to reinforce the perineal body and correct excessive perineal descent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients complaining of obstructed defecation syndrome with anterior rectocele ≥ 3 cm associated with excessive perineal descent with failure of conservative management.
Key exclusion criteria (7 listed)
- Patients with Slow-transit constipation
- Patients with anterior rectocele of < 3 cm
- Patients with complete external rectal prolapse
- Evidence of colorectal carcinoma or Inflammatory bowel disease ( IBD)
- Inability for lifestyle change postoperatively
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 |
|---|---|---|
| STARR ProcedureThe STARR procedure will be performed using PPH circular stapler to achieve trans-anal full-thickness resection of the rectocele | Procedure or surgery | STARR procedure |
| STARR combined with transverse perineal support procedureTransverse perineal support procedure will be added to STARR procedure. it will be done using a non-absorbable polypropylene mesh to reinforce the perineal body and correct excessive perineal descent. | Procedure or surgery | STARR combined with transverse perineal support procedure |
Primary outcome
Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups.
Time frame: Up to 6 months postoperatively
Compare Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups. Obstructed Defecation Syndrome score (ODS-S; Renzi score) ranges from 0 to 20. Higher scores indicate a worse outcome (more severe obstructed defecation symptoms )
6 secondary outcomes
Operative time
Time frame: During surgery
Number of participants with surgical site infection
Time frame: Up to 6 months postoperatively
Postoperative urine retention
Time frame: Within 48 hours postoperatively
Pain intensity
Time frame: Up to 6 months postoperatively
Sexual Function in both groups
Time frame: Up to 6 months postoperatively
Hospitalization period
Time frame: From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery
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 26 Aug 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
Recruiting
Transanal vs Transvaginal Rectal Resection for Anterior Rectocele
Rectocele; Female
Recruiting
Biological OviTex Versus Synthetic Graft in Robotic Prolapse Surgery
Colorectal Disorders, Prolapse
RecruitingPhase 3
Efficacy of Conservative Treatment of Functional Defecatory Disorders in Females With Pelvic Organ Prolapse
Pelvic Floor Prolapse, Functional Constipation
Enrolling by invitationObservational study
Laparoscopic Pectopexy and Laparoscopic Colporrhaphies in Pelvic Organ Prolapse Treatment
Vaginal Vault Prolapse, Uterine Prolapse
Active, not recruitingPhase 4
Rectocele Repair with or Without Internal Sphincter Botulinum Toxin Injection: a Prospective Randomized Trial
Obstructed Defaecation Syndrome, Anterior Rectocele
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.
Haitham M.Azmy Basiouny, MD 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 STARR Procedure and STARR combined with transverse perineal support procedure in people with Rectocele and Perineal Descent, 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: opening soon, as of the sponsor's last update on 26 Aug 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?
Change in Obstructed Defecation Syndrome score (ODS-S; Renzi score) in both groups. (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 26 Aug 2026.