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

NCT07777146 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-08-26

No results posted yet for this study

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.

Conditions

  • Rectocele
  • Perineal Descent

Interventions

PROCEDURE

STARR Procedure

The STARR procedure will be performed using PPH circular stapler to achieve trans-anal full-thickness resection of the rectocele

PROCEDURE

STARR combined with transverse perineal support procedure

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Haitham M.Azmy Basiouny, MD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-02
Primary Completion
2028-01-31
Completion
2028-01-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777146 on ClinicalTrials.gov