Rectal ProlapseRSUPNCT07673406
RECTOSACROUTEROPEXY vs. WELLS
A study testing Modified rectosacrouteropexy and Wells rectopexy in people with Rectal Prolapse and Pelvic Organ Prolapse (POP), run by Azerbaijan Medical University at 1 site in Azerbaijan.
Trial 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… Read more about this study
- Who is it for?
- Ages 47 to 75 years, women only
- Conditions the study is for
- Rectal Prolapse, Pelvic Organ Prolapse (POP)
- What is being tested?
- Modified rectosacrouteropexy and Wells rectopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAzerbaijan
- Study dates
- 1 Jan 2022to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 47 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Efficacy of Surgical Methods When Using Prolene Mesh for Pelvic Organ Prolapse in Women
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:
- Does modified rectosacrouteropexy with pelvic peritonization improve postoperative anatomical outcomes compared with conventional Wells rectopexy?
- 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.
- Conditions
- Rectal Prolapse, Pelvic Organ Prolapse (POP)
- Being tested
- Modified rectosacrouteropexy, Wells rectopexy
- Keywords
- Rectal prolapse, Full-thickness rectal prolapse, Wells rectopexy, Rectosacrouteropexy, Pelvic organ prolapse, Anorectal manometry, Defecography, Pelvic Floor Distress
- Medical subject headings
- Rectal Prolapse, Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified rectosacrouteropexyProcedure or surgery
Surgical treatment for full-thickness rectal prolapse using modified rectosacrouteropexy with pelvic peritonization.
Wells rectopexyProcedure or surgery
Conventional surgical rectopexy procedure for full-thickness rectal prolapse
| Study group | Role | What they receive |
|---|---|---|
| Arm Title: Modified rectosacrouteropexy | Experimental | Participants undergo modified rectosacrouteropexy with pelvic peritonization for full-thickness rectal prolapse. Receives: Procedure: Modified rectosacrouteropexy |
| Arm Title: Wells rectopexy | Active comparator | Participants undergo conventional Wells rectopexy for full-thickness rectal prolapse Receives: Procedure: Wells rectopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative rectal prolapse recurrence
Recurrence of full-thickness rectal prolapse after surgery, assessed during postoperative follow-up
Measured: Up to 24 months after surgery
Secondary outcomes (1)
Postoperative complications
Occurrence of postoperative complications, including constipation, fistula formation, and mesh-related complications.
Measured: Up to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Jan 2022
- Primary completion15 May 2026
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azerbaijan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahira Amirova, Azerbaijan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673406
- Sponsor's protocol ID
- AMU-2026-STUDY-01
- Other IDs
- 29/11/2019 Protocol N10
- Acronym
- RSUP
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Efficacy of Surgical Methods When Using Prolene Mesh for Pelvic Organ Prolapse in Women
- ClinicalTrials.gov ID
- NCT07673406
- Acronym / sponsor ID
- RSUP / AMU-2026-STUDY-01
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Azerbaijan Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 May 2026 (actual)
- Study completion
- Jan 2028 (estimated)
- First posted
- 29 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does modified rectosacrouteropexy with pelvic peritonization improve postoperative anatomical outcomes compared with conventional Wells rectopexy?
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Title: Modified rectosacrouteropexy | Experimental | Procedure: Modified rectosacrouteropexyParticipants undergo modified rectosacrouteropexy with pelvic peritonization for full-thickness rectal prolapse. |
| Arm Title: Wells rectopexy | Active comparator | Procedure: Wells rectopexyParticipants undergo conventional Wells rectopexy for full-thickness rectal prolapse |
Who may qualify
- Ages
- 47 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified rectosacrouteropexySurgical treatment for full-thickness rectal prolapse using modified rectosacrouteropexy with pelvic peritonization. | Procedure or surgery | Arm Title: Modified rectosacrouteropexy |
| Wells rectopexyConventional surgical rectopexy procedure for full-thickness rectal prolapse | Procedure or surgery | Arm Title: Wells rectopexy |
Primary outcome
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
1 secondary outcome
Postoperative complications
Time frame: Up to 24 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified rectosacrouteropexy and Wells rectopexy in people with Rectal Prolapse and Pelvic Organ Prolapse (POP), run by Azerbaijan Medical University at 1 site in Azerbaijan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Azerbaijan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative rectal prolapse recurrence (time frame: Up to 24 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.