Actively Recruiting
Efficacy and Safety of Intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR) Versus Conventional Laparoscopic Surgery for Bowel Endometriosis: A Multicenter, Open-Label, Randomized Controlled Trial (LUMEN-01)
Led by Obstetrics & Gynecology Hospital of Fudan University · Updated on 2026-05-19
192
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Premenopausal women aged 18 to 55 years
- Confirmed bowel endometriosis lesions involving the muscular layer of the rectum and/or sigmoid colon by preoperative MRI and/or transrectal endosonography
- Pre-treatment Low Anterior Resection Syndrome (LARS) score greater than 20
- Eligible for laparoscopic surgery
- Voluntarily signed informed consent to participate in the study
You will not qualify if you...
- Pregnancy or breastfeeding
- Active inflammatory bowel disease, irritable bowel syndrome, or similar conditions with flare-ups within the past year
- Acute or severe infectious disease within 4 weeks before surgery
- History or suspicion of malignant tumors based on imaging or tumor marker tests
- American Society of Anesthesiologists (ASA) classification Grade III or higher, or severe organ dysfunction preventing general anesthesia and laparoscopic surgery
- Undergoing robot-assisted laparoscopic surgery or open laparotomy
- Participation in other clinical trials that could affect study outcomes
- Previous participation in interventional clinical trials affecting this study
- History of colorectal resection, anastomosis, or stoma surgery
- History of pelvic radiotherapy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and 30 days postoperatively
Participants undergo laparoscopic surgery to localize, observe, and resect bowel endometriosis lesions using either conventional laparoscopy or intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR). Postoperative monitoring for complications occurs within 30 days after surgery.
Approximately 1 surgery day and multiple visits within 30 days postoperatively
Duration - Up to 12 months postoperatively
Participants are followed to assess bowel function, pain relief, gastrointestinal function, quality of life, and other health outcomes up to 12 months after surgery.
Visits at 3, 6, and 12 months after surgery
Trial Site Locations
Total: 3 locations
1
International Peace Maternity and Child Health Hospital
Shanghai, Shanghai Municipality, China, 200030
Not Yet Recruiting
2
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201101
Actively Recruiting
3
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, China, 201101
Not Yet Recruiting
Research Team
X
Xiaofang Yi, MD
K
Kai-kai Chang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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