ClinicalTrials.gg
Active, not recruitingNCT07673406RSUPUpdated Jun 29, 2026

RECTOSACROUTEROPEXY vs. WELLS

An interventional study of Modified rectosacrouteropexy and Wells rectopexy in Rectal Prolapse and Pelvic Organ Prolapse (POP), sponsored by Azerbaijan Medical University. Active, not recruiting at 1 site in Azerbaijan. Open to female participants aged 47 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Azerbaijan Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 years 5 months after the study started (first participant enrolled Jan 2022, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
47 Years to 75 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Rectal Prolapse
  • Pelvic Organ Prolapse (POP)

Keywords

  • Rectal prolapse
  • Full-thickness rectal prolapse
  • Wells rectopexy
  • Rectosacrouteropexy
  • Pelvic organ prolapse
  • Anorectal manometry
  • Defecography
  • Pelvic Floor Distress
03

In context

Rectal Prolapse

55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.

This study's enrollment of 36 is below the median of 55 across 34 interventional studies indexed under Rectal Prolapse.

Browse Rectal Prolapse studies →

Lead sponsor

Azerbaijan Medical University is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
47 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Male patients Patients without full-thickness rectal prolapse to surgery or anesthesia Severe uncontrolled medical condition that could interfere with participation or follow-up
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Arm Title: Modified rectosacrouteropexy

    Participants undergo modified rectosacrouteropexy with pelvic peritonization for full-thickness rectal prolapse.

    Procedure: Modified rectosacrouteropexy

  • Active comparator
    Arm Title: Wells rectopexy

    Participants undergo conventional Wells rectopexy for full-thickness rectal prolapse

    Procedure: Wells rectopexy

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

06

What researchers measure

Primary outcomes

  1. Postoperative rectal prolapse recurrence

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

    Time frame: Up to 24 months after surgery

Secondary outcomes

  1. Postoperative complications

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

    Time frame: Up to 24 months after surgery

07

Study locations

1 site
  • Surgery, Biochemistry
    Baku, AZ1030, Azerbaijan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07673406
Lead sponsor
Azerbaijan Medical University
Responsible party
Mahira Amirova (Assoc.Prof, Azerbaijan Medical University) — Principal investigator
First posted
Jun 29, 2026
Start date
Jan 1, 2022
Primary completion
May 15, 2026
Completion
Jan 2028 (estimated)
Last update
Jun 29, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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