An interventional study of STARR Procedure and STARR combined with transverse perineal support procedure in Rectocele and Perineal Descent, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
50 studies on the registry are indexed under Rectocele; 9 are open to participants now.
This study's planned enrollment of 64 is close to the median of 62 across 37 interventional studies indexed under Rectocele.
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Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
STARR will be done using PPH circular stapler to achieve trans-anal full-thickness resection of the rectocele
Procedure: STARR Procedure
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.
Procedure: STARR combined with transverse perineal support procedure
The STARR procedure will be performed using PPH circular stapler to achieve trans-anal full-thickness resection of the rectocele
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.
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 )
Time frame: Up to 6 months postoperatively
Operative time
Compare time of operation between both procedure
Time frame: 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.)
Time frame: 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).
Time frame: 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})
Time frame: 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
Time frame: Up to 6 months postoperatively
Hospitalization period
Compare how many days patients stay in hospital in both groups
Time frame: From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery
Plan to share: 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
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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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