Prospective Randomized Controlled Trial of Obstructed Defecation Surgery

Last updated: March 21, 2025
Sponsor: Endeavor Health
Overall Status: Active - Recruiting

Phase

N/A

Condition

Genitourinary Prolapse

Treatment

Transvaginal sacrospinous rectopexy

Laparoscopic abdominal ventral rectopexy

Clinical Study ID

NCT05747027
EH22-284
  • Ages 18-80
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female, between the age of 18 and 80

  2. OD symptoms as indicated by an affirmative response to either questions 7, 8 or 14of the Pelvic Floor Distress Inventory (PFDI):

  3. Do you feel you need to strain too hard to have a bowel movement?

  4. Do you feel you have not completely emptied your bowels at the end of a bowelmovement?

  5. Does part of your bowel ever pass through the rectum and bulge outside duringor after a bowel movement?

  6. Rectal hypermobility defined as a compression ratio greater than 50% according toultrasound

  7. Patient planning on undergoing surgery for the repair of pelvic organ prolapsewithin the next 12 months

  8. Patient who is not pregnant and does not intend to become pregnant in the next 2years

  9. Available for 24-months of follow-up

  10. Stated willingness to comply with all study procedures and availability for theduration of the study

  11. Able to complete study assessments, per clinician judgment

  12. Able and willing to provide independent written informed consent

  13. Stable cardiovascular and respiratory status to meet candidacy in vaginal orlaparoscopic surgeries

Exclusion

Exclusion Criteria:

  1. Contraindication to abdominal and transvaginal rectopexy in the opinion of thetreating surgeon

  2. History of previous surgery that included any type of surgery for rectal prolapse

  3. Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMTprogram

  4. Previous adverse reaction to synthetic mesh

  5. Current cytotoxic chemotherapy or current or history of pelvic radiation therapywithin 12 months

  6. History of two inpatient hospitalizations for medical comorbidities in the previous 12 months

Study Design

Total Participants: 120
Treatment Group(s): 2
Primary Treatment: Transvaginal sacrospinous rectopexy
Phase:
Study Start date:
May 16, 2024
Estimated Completion Date:
February 29, 2028

Connect with a study center

  • Endeavor Health

    Skokie, Illinois 60076
    United States

    Active - Recruiting

  • Weill Cornell Medicine

    New York, New York 10065
    United States

    Active - Recruiting

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