NCT07673406

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Jan 2022Jan 2028

Study Start

First participant enrolled

January 1, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2026

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Expected
Last Updated

June 29, 2026

Status Verified

June 1, 2026

Enrollment Period

4.4 years

First QC Date

June 23, 2026

Last Update Submit

June 23, 2026

Conditions

Rectal ProlapsePelvic Organ Prolapse (POP)

Keywords

Rectal prolapseFull-thickness rectal prolapseWells rectopexyRectosacrouteropexyPelvic organ prolapseAnorectal manometryDefecographyPelvic Floor Distress

Outcome Measures

Primary Outcomes (1)

  • Postoperative rectal prolapse recurrence

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

    Up to 24 months after surgery

Secondary Outcomes (1)

  • Postoperative complications

    Up to 24 months after surgery

Study Arms (2)

Arm Title: Modified rectosacrouteropexy

EXPERIMENTAL

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

Procedure: Modified rectosacrouteropexy

Arm Title: Wells rectopexy

ACTIVE COMPARATOR

Participants undergo conventional Wells rectopexy for full-thickness rectal prolapse

Procedure: Wells rectopexy

Interventions

Modified rectosacrouteropexyPROCEDURE

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

Arm Title: Modified rectosacrouteropexy
Wells rectopexyPROCEDURE

Conventional surgical rectopexy procedure for full-thickness rectal prolapse

Arm Title: Wells rectopexy

Eligibility Criteria

Age47 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients with full-thickness rectal prolapse were eligible for this study
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgery, Biochemistry

Baku, AZ1030, Azerbaijan

Location

MeSH Terms

Conditions

Rectal ProlapsePelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Not informed
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc.Prof

Study Record Dates

First Submitted

June 23, 2026

First Posted

June 29, 2026

Study Start

January 1, 2022

Primary Completion

May 15, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

June 29, 2026

Record last verified: 2026-06

Locations

AZ(1)