Prospective Randomized Controlled Trial of Obstructed Defecation Surgery (NCT05747027) | Clinical Trial Compass
TerminatedNot Applicable
Prospective Randomized Controlled Trial of Obstructed Defecation Surgery
Stopped: Due to low recruitment rate
United States15 participantsStarted 2024-05-16
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexFEMALE
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Inclusion criteria
✓. Female, between the age of 18 and 80
✓. OD symptoms as indicated by an affirmative response to either questions 7, 8 or 14 of the Pelvic Floor Distress Inventory (PFDI):
✓. Do you feel you need to strain too hard to have a bowel movement?
✓. Do you feel you have not completely emptied your bowels at the end of a bowel movement?
✓. Does part of your bowel ever pass through the rectum and bulge outside during or after a bowel movement?
✓. Rectal hypermobility defined as a compression ratio greater than 50% according to ultrasound
✓. Patient planning on undergoing surgery for the repair of pelvic organ prolapse within the next 12 months
✓. Patient who is not pregnant and does not intend to become pregnant in the next 2 years
Exclusion criteria
✕. Contraindication to abdominal and transvaginal rectopexy in the opinion of the treating surgeon
What they're measuring
1
Degree of Rectal Hypermobility Measured Via Ultrasound