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NCT05747027 · ClinicalTrials.gov registry record · NA

Prospective Randomized Controlled Trial of Obstructed Defecation Surgery

A NA study, sponsored by Endeavor Health.

Terminated
Registry status
NA
Development phase
15
Enrollment target

NCT05747027: Clinical Trial NA study, sponsored by Endeavor Health.

NCT05747027 is a NA study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05747027, a NA study, was terminated before completion, sponsored by Endeavor Health.

TERMINATED
Registry status
NA
Development phase
15 participants
Enrollment target

Study Summary

Obstructive defecatory syndrome (ODS) or inability to completely empty bowel is characterized by a combination of straining, incomplete evacuation, and the use of digital manipulation with bowel movement. This is a common condition with estimated incidence of 15-20% in the adult female population. Laparoscopic abdominal ventral rectopexy is an established surgical technique aimed at restoring rectal support in women with this condition. It is the most common surgery used nowadays to treat ODS. Transvaginal sacrospinous rectopexy, is an innovative procedure which has been shown to be safe and effective in the treatment of stool entrapment. Currently it is unknown whether one of the procedures mentioned is superior to the other regarding surgical outcomes and patient experience. The purpose of this research is to compare the outcomes of these two procedures considering their efficacy to improve symptoms. During the study, participants will be randomized to undergo one of two procedures for treatment of inability to completely empty their bowel and/or rectal prolapse: 1) laparoscopic abdominal ventral rectopexy; 2) transvaginal sacrospinous rectopexy. Following the procedure, participants will be asked to return to the office for a follow-up visit 2-weeks, 2-, 12- and 24-months after the surgery. During each follow-up visit participants will undergo symptom evaluation, pelvic exam and transvaginal pelvic ultrasound to evaluate surgical success.

Primary Outcome

The degree of rectal hypermobility measured via ultrasound (i.e. compression ratio).

Interventions

  • PROCEDURE Laparoscopic abdominal ventral rectopexy
  • PROCEDURE Transvaginal sacrospinous rectopexy

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2024-05-16
Est. Completion 2025-05-30
Phase NA
Endeavor Health

94 total trials

Why NCT05747027 stopped before completion

NCT05747027 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Laparoscopic abdominal ventral rectopexy is the first listed.

NCT05747027 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05747027 about?

NCT05747027 is a clinical study titled "Prospective Randomized Controlled Trial of Obstructed Defecation Surgery". Obstructive defecatory syndrome (ODS) or inability to completely empty bowel is characterized by a combination of straining, incomplete evacuation, and the use of digital manipulation with bowel movement. This is a common condition with estimated incidence of 15-20% in the adult female population. ...

What is the current status of trial NCT05747027?

This trial is currently terminated. It is a NA study. The enrollment target is 15 participants. The study started on 2024-05-16. Estimated completion is 2025-05-30.

What interventions are being tested in trial NCT05747027?

The interventions under investigation include: Laparoscopic abdominal ventral rectopexy (PROCEDURE), Transvaginal sacrospinous rectopexy (PROCEDURE).

Who is sponsoring clinical trial NCT05747027?

This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05747027's enrollment target sits among peer trials

15 1881st of 2000 higher than 92 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05747027, the US trial registry maintained by the National Library of Medicine. NCT05747027 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.