Laparoscopic Ventral Mesh Rectopexy Combined With or Without Stapled Trans-anal Rectal Resection for Obstructed Defecation Syndrome

Launched by RENMIN HOSPITAL OF WUHAN UNIVERSITY · Feb 18, 2017

Keywords

ClinConnect Summary

This clinical trial is studying two surgical approaches to help women with a condition called obstructed defecation syndrome (ODS), which makes it difficult to have bowel movements. The trial compares laparoscopic ventral mesh rectopexy (a minimally invasive surgery that helps to support the rectum) alone versus this surgery combined with another procedure called stapled trans-anal rectal resection, which removes part of the rectum. The goal is to see which method provides better results for patients in terms of how well they can have bowel movements and how their anatomy looks after the surgery.

To participate in this trial, women aged 65 to 75 who have been experiencing symptoms of ODS for at least a year may be eligible. They should have a significant score indicating their ODS severity and have tried medical treatments for at least six months without success. Participants can expect to undergo one of the two surgical procedures being studied, and their progress will be monitored to determine the effectiveness of each approach. It's important to note that there are specific health conditions that might exclude someone from participating, such as certain types of constipation or previous surgeries in the area.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Patients affected by obstructed defecation with a minimum ODS score of 10
• • External rectal prolapse or high-grade internal rectal prolapse
• • Often experience excessive straining, sense of incomplete evacuation, and/or prolonged time for complete evacuation when attempting a bowel movement
• • Have experienced ODS symptoms for at least 12 months prior to enrollment
• • Failure of at least 6 months of medical therapy
• • American Society of Anesthesiologists (ASA) score of no more than 3
• Exclusion Criteria:
• • Slow transit constipation
• • Anismus resistant to conventional treatment
• • No demonstrable pelvic anatomical problem
• • Previous rectal or anal surgery
• • Recto-vaginal fistula
• • Pregnancy
• • Previous pelvic radiotherapy
• • Severe proctitis or significant rectal fibrosis
• • Evidence of colorectal neoplasia, carcinoma, or inflammatory bowel disease
• • Perineal infection
• • High-grade endometriosis
• • Morbid obesity
• • A hostile abdomen
• • Psychological instability