Comparing two surgical procedures for obstructed defecation
Prospective Randomized Controlled Trial Comparing Transvaginal Rectopexy and Ventral Mesh Rectopexy for Obstructed Defecation in Pelvic Organ Prolapse (PROD Trial)
This study tests which of two surgical options works better for women with obstructed defecation syndrome to help improve their bowel function and relieve symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Endeavor Health Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Skokie, Illinois and 1 other locations) |
| Trial ID | NCT05747027 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the outcomes of two surgical techniques, laparoscopic abdominal ventral rectopexy and transvaginal sacrospinous rectopexy, for treating obstructed defecation syndrome in women. Participants will be randomized to receive one of the two procedures, which are designed to restore rectal support and improve bowel function. The study will evaluate the efficacy of each procedure in alleviating symptoms associated with obstructed defecation. The trial will also assess patient experiences and surgical outcomes over a follow-up period of 24 months.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 80 who experience symptoms of obstructed defecation and have rectal hypermobility.
Not a fit: Patients who are pregnant or planning to become pregnant within the next two years will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide women with obstructed defecation a more effective surgical option to improve their bowel function and quality of life.
How similar studies have performed: While laparoscopic abdominal ventral rectopexy is an established technique, the comparison with transvaginal sacrospinous rectopexy is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 14 of the Pelvic Floor Distress Inventory (PFDI): 1. Do you feel you need to strain too hard to have a bowel movement? 2. Do you feel you have not completely emptied your bowels at the end of a bowel movement? 3. Does part of your bowel ever pass through the rectum and bulge outside during or after a bowel movement? 3. Rectal hypermobility defined as a compression ratio greater than 50% according to ultrasound 4. Patient planning on undergoing surgery for the repair of pelvic organ prolapse within the next 12 months 5. Patient who is not pregnant and does not intend to become pregnant in the next 2 years 6. Available for 24-months of follow-up 7. Stated willingness to comply with all study procedures and availability for the duration of the study 8. Able to complete study assessments, per clinician judgment 9. Able and willing to provide independent written informed consent 10. Stable cardiovascular and respiratory status to meet candidacy in vaginal or laparoscopic surgeries Exclusion Criteria: 1. Contraindication to abdominal and transvaginal rectopexy in the opinion of the treating 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 PMT program 4. Previous adverse reaction to synthetic mesh 5. Current cytotoxic chemotherapy or current or history of pelvic radiation therapy within 12 months 6. History of two inpatient hospitalizations for medical comorbidities in the previous 12 months
Where this trial is running
Skokie, Illinois and 1 other locations
- Endeavor Health — Skokie, Illinois, United States (Recruiting)
- Weill Cornell Medicine — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Ghazaleh Rostami Nia, MD — Endeavor Health
- Study coordinator: Jungeun (Camilla) Lee, MS
- Email: JLee5@northshore.org
- Phone: 847-570-4729
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.