Transanal versus Transvaginal rectal resection for anterior rectocele
Outcomes of Transanal Versus Transvaginal Rectal Resection for Anterior Rectocele: A Randomized Controlled Trial
This project will test two surgical techniques—stapled transanal and stapled transvaginal rectal resection—to see which better relieves obstructed defecation in women with anterior rectocele.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo, Al-Manial, Cairo, Egypt) |
| Trial ID | NCT07375147 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial enrolls adult women with obstructed defecation due to an anterior rectocele of at least 3 cm who have failed conservative treatment. After consent and preoperative workup including defecography and anorectal examination, participants are randomized 1:1 to receive either stapled transanal rectal resection or stapled transvaginal rectal resection performed by experienced colorectal surgeons. The primary outcome is change in obstructed defecation symptoms measured by the Cleveland Clinic Constipation (CCC) score, with secondary outcomes including operative time, postoperative pain, continence status, complications, and length of hospital stay. Outcomes and complication rates will be compared between the two groups over the postoperative follow-up period.
Who should consider this trial
Good fit: Adult women with symptomatic obstructed defecation due to an anterior rectocele ≥3 cm on straining who have failed conservative management and meet other eligibility criteria are ideal candidates.
Not a fit: Patients with slow-transit constipation, rectocele <3 cm, complete external rectal prolapse, inflammatory bowel disease, colorectal cancer, prior rectal or rectocele surgery, or inability to follow postoperative recommendations are unlikely to benefit from these procedures in this trial.
Why it matters
Potential benefit: If one technique proves superior, patients could gain better symptom relief, fewer complications, and faster recovery after surgery.
How similar studies have performed: Both stapled transanal (STARR) and transvaginal repairs have been used in prior cohorts and some trials with symptom improvement reported, but direct randomized comparisons remain limited and results have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Cairo, Al-Manial, Cairo, Egypt
- Faculty of medicine, Cairo University — Cairo, Al-Manial, Cairo, Egypt, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmed Mohamed Abdelaal, Lecturer
- Email: drabdelaal90@gmail.com
- Phone: +201118732767
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.