Last reviewed · How we verify

NCT05747027: PROD

Prospective Randomized Controlled Trial of Obstructed Defecation Surgery

Terminated NA Results posted Last updated 15 July 2025
What this trial tests

NA trial testing Laparoscopic abdominal ventral rectopexy in Obstructed Defecation in 15 participants. Terminated before completion.

Timeline
16 May 2024
Primary endpoint
30 May 2025
30 May 2025

Quick facts

Lead sponsorEndeavor Health
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment15
Start date16 May 2024
Primary completion30 May 2025
Estimated completion30 May 2025
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Endeavor Health — full company profile →

Who can join

Adults 18 to 80, female only, with Obstructed Defecation or Pelvic Organ Prolapse. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other Endeavor Health trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05747027.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing