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NCT Number: NCT07777146

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

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 Altomare Obstructed Defecation Syndrome (ODS) 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.

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Key information

Conditions

Rectocele Digestive System Diseases Gastrointestinal Diseases Hernia Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Perineal Descent Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of medicine, Cairo University

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

About this study

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 Altomare Obstructed Defecation Syndrome (ODS) 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

STARR Procedure

Procedure

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

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.

Primary outcomes

  1. Change in Altomare Obstructed Defecation Syndrome (ODS) score in both groups.

    Time frame: Up to 6 months postoperatively

    Compare Change in Altomare Obstructed Defecation Syndrome (ODS) score in both groups. Altomare Obstructed Defecation Syndrome (ODS) score ranges from 0 to 31. Higher scores indicate a worse outcome (more severe obstructed defecation symptoms )

Secondary outcomes

  1. Operative time

    Time frame: During surgery

    Compare time of operation between both procedure

  2. Number of participants with surgical site infection

    Time frame: Up to 6 months postoperatively

    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.)

  3. Postoperative urine retention

    Time frame: Within 48 hours postoperatively

    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).

  4. Pain intensity

    Time frame: Up to 6 months postoperatively

    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})

  5. Sexual Function in both groups

    Time frame: Up to 6 months postoperatively

    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

  6. Hospitalization period

    Time frame: From date of hospital admission until date of hospital discharge, assessed up to 10 days after surgery

    Compare how many days patients stay in hospital in both groups

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed Mohamed Abdelaal, Lecturer

CONTACT

[email protected]

+201118732767

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Adding Transverse Perineal Support to Stapled Transanal Rectal Resection for Anterior Rectocele With Excessive Perineal Descent: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 20, 2026
Registry last updated
Aug 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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