NCT05747027

Prospective Randomized Controlled Trial of Obstructed Defecation Surgery

Prospective Randomized Controlled Trial Comparing Transvaginal Rectopexy and Ventral Mesh Rectopexy for Obstructed Defecation in Pelvic Organ Prolapse (PROD Trial)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Endeavor Health · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructed Defecation
• Pelvic Organ Prolapse

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic abdominal ventral rectopexy	Laparoscopic abdominal ventral rectopexy is an established surgical technique used to restore rectal support in women with obstructive defecatory syndrome (ODS). It is the most common surgery used to treat ODS. It involves a series of small cuts in the abdomen and the use of mesh to hold the rectum in the correct position.
PROCEDURE	Transvaginal sacrospinous rectopexy	Transvaginal sacrospinous rectopexy is an innovative procedure which has shown to be safe and effective in the treatment of stool entrapment. This is a mesh-free and vaginal route procedure.

Timeline

• Start date: 2024-05-16
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2023-02-28
• Last updated: 2025-07-15
• Results posted: 2025-07-15

Locations

2 sites across 1 country: United States