TERMINATED

Prospective Randomized Controlled Trial of Obstructed Defecation Surgery

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Conditions

Obstructed DefecationPelvic Organ ProlapseRectopexyTransvaginal rectopexyLaparoscopic ventral rectopexy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-05-16
Study Completion:2025-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT05747027

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Female, between the age of 18 and 80
  2. 2. OD symptoms as indicated by an affirmative response to either questions 7, 8 or 14 of the Pelvic Floor Distress Inventory (PFDI):
  3. 1. Do you feel you need to strain too hard to have a bowel movement?
  4. 2. Do you feel you have not completely emptied your bowels at the end of a bowel movement?
  5. 3. Does part of your bowel ever pass through the rectum and bulge outside during or after a bowel movement?
  6. 3. Rectal hypermobility defined as a compression ratio greater than 50% according to ultrasound
  7. 4. Patient planning on undergoing surgery for the repair of pelvic organ prolapse within the next 12 months
  8. 5. Patient who is not pregnant and does not intend to become pregnant in the next 2 years
  9. 6. Available for 24-months of follow-up
  10. 7. Stated willingness to comply with all study procedures and availability for the duration of the study
  11. 8. Able to complete study assessments, per clinician judgment
  12. 9. Able and willing to provide independent written informed consent
  13. 10. Stable cardiovascular and respiratory status to meet candidacy in vaginal or laparoscopic surgeries
  1. 1. Contraindication to abdominal and transvaginal rectopexy in the opinion of the treating surgeon
  2. 2. History of previous surgery that included any type of surgery for rectal prolapse
  3. 3. Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT program
  4. 4. Previous adverse reaction to synthetic mesh
  5. 5. Current cytotoxic chemotherapy or current or history of pelvic radiation therapy within 12 months
  6. 6. History of two inpatient hospitalizations for medical comorbidities in the previous 12 months

Contacts and Locations

Principal Investigator

Ghazaleh Rostami Nia, MD
PRINCIPAL_INVESTIGATOR
Endeavor Health

Study Locations (Sites)

Endeavor Health
Skokie, Illinois, 60076
United States
Weill Cornell Medicine
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: Endeavor Health

  • Ghazaleh Rostami Nia, MD, PRINCIPAL_INVESTIGATOR, Endeavor Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-16
Study Completion Date2025-05-30

Study Record Updates

Study Start Date2024-05-16
Study Completion Date2025-05-30

Terms related to this study

Keywords Provided by Researchers

  • Rectopexy
  • Transvaginal rectopexy
  • Laparoscopic ventral rectopexy

Additional Relevant MeSH Terms

  • Obstructed Defecation
  • Pelvic Organ Prolapse