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OpenTrials
Active, Not Recruiting

NCT Number: NCT07673406

RECTOSACROUTEROPEXY vs. WELLS

The goal of this clinical trial was to compare two surgical techniques in female patients with full-thickness rectal prolapse. The main questions it aimed to answer were:

1. Does modified rectosacrouteropexy with pelvic peritonization improve postoperative anatomical outcomes compared with conventional Wells rectopexy? 2. Does modified rectosacrouteropexy with pelvic peritonization improve postoperative functional outcomes compared with conventional Wells rectopexy?

Researchers compared modified rectosacrouteropexy with pelvic peritonization with conventional Wells rectopexy to assess postoperative recurrence, complications, anorectal manometry, defecography findings, and pelvic floor symptom scores. Participants underwent one of the assigned surgical procedures and were followed after surgery with clinical assessment and pelvic floor function testing.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rectal Prolapse Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Pelvic Organ Prolapse (POP) Prolapse Rectal Diseases

Age range

47 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Surgery, Biochemistry

Baku, AZ1030, Azerbaijan

About this study

This is a prospective randomized comparative study conducted at Azerbaijan Medical University. Female patients with full-thickness rectal prolapse are assigned to modified rectosacrouteropexy with pelvic peritonization or conventional Wells rectopexy. Participants are followed for postoperative anatomical and functional outcomes, including recurrence, complications, anorectal manometry findings, defecography findings, and pelvic floor symptom scores.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patients with full-thickness rectal prolapse Patients scheduled for surgical treatment with modified rectosacrouteropexy with pelvic peritonization Ability to complete postoperative follow-up assessments

Exclusion criteria

  • Male patients Patients without full-thickness rectal prolapse Contraindication to surgery or anesthesia Severe uncontrolled medical condition that could interfere with participation or follow-up

Treatment and study plan

Modified rectosacrouteropexy

Procedure

Surgical treatment for full-thickness rectal prolapse using modified rectosacrouteropexy with pelvic peritonization.

Wells rectopexy

Procedure

Conventional surgical rectopexy procedure for full-thickness rectal prolapse

Primary outcomes

  1. Postoperative rectal prolapse recurrence

    Time frame: Up to 24 months after surgery

    Recurrence of full-thickness rectal prolapse after surgery, assessed during postoperative follow-up

Secondary outcomes

  1. Postoperative complications

    Time frame: Up to 24 months after surgery

    Occurrence of postoperative complications, including constipation, fistula formation, and mesh-related complications.

Sponsors and collaborators

Lead sponsor

Azerbaijan Medical University

Other

Registry information

Official study title

A Study of the Efficacy of Surgical Methods When Using Prolene Mesh for Pelvic Organ Prolapse in Women

Acronym: RSUP

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Jun 29, 2026
Registry last updated
Jun 29, 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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