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RECTOSACROUTEROPEXY vs. WELLS

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07673406
Acronym
RSUP
Enrollment
36
Registered
2026-06-29
Start date
2022-01-01
Completion date
2028-01-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Organ Prolapse (POP), Rectal Prolapse

Keywords

Rectal prolapse, Full-thickness rectal prolapse, Wells rectopexy, Rectosacrouteropexy, Pelvic organ prolapse, Anorectal manometry, Defecography, Pelvic Floor Distress

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREModified rectosacrouteropexy

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

PROCEDUREWells rectopexy

Conventional surgical rectopexy procedure for full-thickness rectal prolapse

Sponsors

Azerbaijan Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Not informed

Eligibility

Sex/Gender
FEMALE
Age
47 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative rectal prolapse recurrenceUp to 24 months after surgeryRecurrence of full-thickness rectal prolapse after surgery, assessed during postoperative follow-up

Secondary

MeasureTime frameDescription
Postoperative complicationsUp to 24 months after surgeryOccurrence of postoperative complications, including constipation, fistula formation, and mesh-related complications.

Countries

Azerbaijan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026