Prospective Randomized Controlled Trial of Obstructed Defecation Surgery

Launched by ENDEAVOR HEALTH · Feb 16, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating two different surgical procedures to treat obstructed defecation, a condition where individuals struggle to empty their bowels completely. The two surgeries being compared are laparoscopic abdominal ventral rectopexy, a well-established technique, and transvaginal sacrospinous rectopexy, a newer method. Both surgeries aim to help women who experience symptoms like straining, incomplete bowel movements, or rectal prolapse. Researchers want to find out which procedure is more effective in improving these symptoms and enhancing patients' quality of life.

To participate in the trial, women aged 18 to 80 who have these bowel issues may be eligible if they meet specific criteria, such as experiencing symptoms of obstructed defecation and having rectal hypermobility. Participants will be randomly assigned to one of the two surgical procedures and will return for follow-up visits at 2 weeks, 2 months, 12 months, and 24 months after their surgery. During these visits, they will discuss their symptoms and undergo exams to assess how well the surgery worked. This study is currently recruiting participants, and involvement will help determine the best treatment for women facing these challenging bowel issues.

Gender

FEMALE

Eligibility 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