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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 is a NA study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 15 participants.
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.
Interventions
- PROCEDURE Laparoscopic abdominal ventral rectopexy
- PROCEDURE Transvaginal sacrospinous rectopexy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2024-05-16 |
| Est. Completion | 2025-05-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05747027
The ClinicalTrials.gov registry entry for NCT05747027 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Laparoscopic abdominal ventral rectopexy is the first listed.
NCT05747027 reports 0 study locations.
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.
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