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

RecruitingNAAges 18 Years - 55 YearsFemaleObstetrics & Gynecology Hospital of Fudan Univers…
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In plain words

What the trial is, and whether it could suit you

The goal of this prospective, multicenter, randomized controlled trial is to compare the clinical efficacy and safety of intra-operative dual laparoscopy and neo-rectoscopy (IDLnR) versus conventional laparoscopy (CL) in patients with bowel endometriosis (BE) undergoing surgery. The primary objective is to assess differences in postoperative bowel function improvement at 6 months between the two groups. The main questions it aims to answer are: Is there a significant difference in postoperative bowel function (primary endpoint) at 6 months postoperatively between IDLnR and CL groups? Do the two groups differ in secondary outcomes, including efficacy indicators (LARS score/cure rate/improvement rate, CRADI-8, Wexner score, GIQLI, EHP-30, VAS pain reduction) and safety indicators (30-day severe complications, antibiotic use intensity, hospital stay \>7 days)? Researchers will randomize B

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • conventional laparoscopy group
  • intra-operative Dual Laparoscopy and Neo-rectoscopy
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Where

3 sites
International Peace Maternity and Child Health Hospital
Shanghai, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, China
Shanghai First Maternity and Infant Hospital
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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