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

Bowel EndometriosisEndometriosisIntestinal Endometriosis

Tagged with

endometriosis

Interventions

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

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