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Not Yet Recruiting NCT07777146

Transverse Perineal Support With STARR for Anterior Rectocele With Excessive Perineal Descent

Conditions: Rectocele, Perineal Descent

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 64
Sponsor: Cairo University

Location: Faculty of medicine, Cairo University Cairo Al-Manial, Cairo, Egypt, Egypt

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. 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.

Eligibility Criteria

Inclusion Criteria: * Adult patients complaining of obstructed defecation syndrome with anterior rectocele ≥ 3 cm associated with excessive perineal descent with failure of conservative management. Exclusion Criteria: * 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07777146). StuddyBuddy aggregates publicly available trial information.