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Actively Recruiting

Phase Not Applicable
Age: 18Years - 55Years
FEMALE
ID07523308

Comparing Intra-operative Dual Laparoscopy and Neo-rectoscopy to Conventional Laparoscopic Surgery for Bowel Endometriosis in Women Aged 18 to 55

Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2026-05-19

192

Participants Needed

3

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are comparing two surgical methods for bowel endometriosis BE intra-operative dual laparoscopy and neo-rectoscopy IDLnR versus conventional laparoscopy CL. This prospective, multicenter, randomized controlled trial aims to assess differences in bowel function improvement six months after surgery. The study also evaluates safety and efficacy measures to support optimized treatment strategies for complete lesion removal and better long-term quality of life for patients with intestinal endometriosis. Participants will undergo either the novel IDLnR procedure, which combines laparoscopic exploration with intra-operative neo-rectoscopy for precise lesion localization and resection, or the conventional laparoscopic surgery focusing on lesion removal alone. Both surgical approaches are completed laparoscopically. The study compares the two groups for bowel function, pain relief, gastrointestinal function, quality of life, and postoperative complications. During the study, patients will be followed at baseline and multiple intervals up to 12 months postoperatively. Assessments include the Low Anterior Resection Syndrome LARS score, Colorectal Anal Distress Inventory-8, Wexner constipation score, Gastrointestinal Quality of Life Index, Endometriosis Health Profile-30, and pain levels. Safety will be monitored through complication rates within 30 days, antibiotic use, and hospital stay duration. This comprehensive follow-up helps evaluate the clinical value of IDLnR compared to conventional laparoscopy.

CONDITIONS

Brief Title

Efficacy and Safety of Intra-operative Dual Laparoscopy and Neo-rectoscopy for Bowel Endometriosis: The LUMEN-01 Trial

Research Team

X

Xiaofang Yi, MD

K

Kai-kai Chang, MD

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