Efficacy and Safety of Intra-operative Dual Laparoscopy and Neo-rectoscopy for Bowel Endometriosis: The LUMEN-01 Trial
NCT07523308
· ctgov
recruiting
- Enrollment
- 192
- Start
- 2026-04-13
- Completion
- 2028-05-31
- Last updated
- 2026-05-19
- Has results
- False
- Countries
- China
Conditions
Tagged with
Interventions
-
conventional laparoscopy group
PROCEDURE
Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically.
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intra-operative Dual Laparoscopy and Neo-rectoscopy
PROCEDURE
Underwent localization, observation and resection of bowel lesions using intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR). The surgery for bowel endometriosis was completed laparoscopically.
Eligibility criteria
Inclusion Criteria:
* Premenopausal women aged 18 to 55 years.
* Preoperative pelvic contrast-enhanced MRI and/or transrectal endosonography confirmed bowel endometriosis (BE) lesions involving the muscular layer of the intestinal wall, located in the rectum and/or sigmoid colon. Postoperative pathological diagnosis serves as the gold standard.
* Pre-treatment LARS score \> 20.
* Eligible for laparoscopic surgery.
* Voluntarily participated in this study and signed written informed consent
Exclusion Criteria:
* Pregnancy or lactation.
* Presence of active inflammatory bowel disease, irritable bowel syndrome, or other similar conditions with disease flare-ups within the past 1 year.
* Acute or severe infectious disease within 4 weeks prior to surgery.
* History of malignant tumor, or highly suspected gynecological/gastrointestinal malignancy based on preoperative imaging or tumor marker tests.
* American Society of Anesthesiologists (ASA) physical status classification ≥ Grade Ⅲ, or severe cardiac, pulmonary, hepatic, renal, or coagulation dysfunction that precludes general anesthesia and elective laparoscopic surgery.
* Undergoing robot-assisted laparoscopic surgery or open laparotomy.
* Currently participating in other clinical trials that may affect the outcome assessment of this study.
* Previous participation in other interventional clinical trials that may affect the outcome assessment of this study.
* History of colorectal resection and anastomosis or stoma surgery.
* History of pelvic radiotherapy.
License: public-domain-us
· commercial use OK
· attribution required
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine
Courtesy of ClinicalTrials.gov / U.S. National Library of Medicine