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

NCT07777146 | Not Yet Recruiting

• 1 other identifier: MD-168-2026
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rectocele; Perineal Descent; Transverse Perineal Support

Outcome Measures

Primary Outcomes (1)

• 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 )

  Up to 6 months postoperatively

Secondary Outcomes (6)

• Operative time

  During surgery

• Number of participants with surgical site infection

  Up to 6 months postoperatively

• Postoperative urine retention

  Within 48 hours postoperatively

• Pain intensity

  Up to 6 months postoperatively

• Sexual Function in both groups

  Up to 6 months postoperatively

Study Arms (2)

STARR procedure

ACTIVE COMPARATOR

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

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.

Procedure: STARR combined with transverse perineal support procedure

Interventions

STARR Procedure PROCEDURE

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

STARR procedure

STARR combined with transverse perineal support procedure 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.

STARR combined with transverse perineal support procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients complaining of obstructed defecation syndrome with anterior rectocele ≥ 3 cm associated with excessive perineal descent with failure of conservative management.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of medicine, Cairo University

Cairo, Al-Manial, Cairo, Egypt, Egypt, 11451, Egypt

Location

MeSH Terms

Conditions

Rectocele

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Haitham M.Azmy Basiouny, MD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed Mohamed Abdelaal, Lecturer

CONTACT

+201118732767; drabdelaal90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 18, 2026
• First Posted: August 20, 2026
• Study Start: September 2, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)