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

Официальное название

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)

Обзор

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 BE surgical patients to IDLnR or CL groups, then compare the above primary and secondary endpoints to evaluate IDLnR's clinical value. Participants will undergo either IDLnR or CL surgery for BE lesions, and be followed up to assess bowel function, quality of life, pain, and safety outcomes as specified. This study will fill evidence gaps for IDLnR in BE surgery, support its standardized application, optimize BE treatment strategies, and aim for complete lesion resection, preserved intestinal function, and improved long-term patient quality of life.

Подробное описание

1\. Objective Primary Objective: To evaluate the improvement in bowel function at 6 months postoperatively between the double-scope group (Intra-operative Dual Laparoscopy and Neo-rectoscopy, IDLnR) and the conventional laparoscopy group (CL) in patients with intestinal endometriosis.

Secondary Objectives:

1. To evaluate the incidence of complications and severe complications within 30 days postoperatively in both groups, including anastomotic leakage, intestinal injury, intestinal bleeding, etc. 2. To evaluate changes in postoperative pain relief, gastrointestinal function, and quality of life between the two groups.

Вмешательства

• Процедура conventional laparoscopy group
  Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically.
• Процедура intra-operative Dual Laparoscopy and Neo-rectoscopy
  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.

Первичные конечные точки

• The improvement rate of the Low Anterior Resection Syndrome (LARS) score grade at 6 months after bowel surgery. [Срок оценки: baseline, and 6 months after bowel surgery]

Вторичные конечные точки (11)

• LARS cure rate (LARS grade improved to no LARS at 12 months postoperatively) [Срок оценки: baseline, and 12 months postoperatively]
• LARS improvement rate (decrease in LARS grade at 3 and 12 months postoperatively) [Срок оценки: baseline, 3 and 12 months postoperatively]
• Change in LARS score (changes from baseline at 3, 6, and 12 months postoperatively) [Срок оценки: baseline, 3, 6, and 12 months postoperatively]
• Change in Colorectal Anal Distress Inventory-8 (CRADI-8) score (change from baseline at 6 months postoperatively) [Срок оценки: baseline, and 6 months postoperatively]
• Change in Wexner constipation score (change from baseline at 12 months postoperatively) [Срок оценки: baseline, 12 months postoperatively]
• Change in Gastrointestinal Quality of Life Index (GIQLI) score (changes from baseline at 6 and 12 months postoperatively). [Срок оценки: baseline, 6 and 12 months postoperatively]
• Change in Endometriosis Health Profile-30 (EHP-30) score (changes from baseline at 6 and 12 months postoperatively) [Срок оценки: baseline, 6 and 12 months postoperatively]
• Proportion of patients with ≥ 50% reduction in Visual Analogue Scale (VAS) score at 6 months postoperatively compared with baseline. [Срок оценки: baseline, and 6 months postoperatively]
• Incidence of severe complications within 30 days postoperatively [Срок оценки: within 30 days postoperatively]
• Antibiotic Use Intensity within 7 days postoperatively [Срок оценки: 0-7 days postoperatively]
• Proportion of patients with postoperative hospital stay > 7 days [Срок оценки: 30 days postoperatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• International Peace Maternity and Child Health Hospital — Шанхай
• Obstetrics and Gynecology Hospital of Fudan University — Шанхай
• Shanghai First Maternity and Infant Hospital — Шанхай

Идентификаторы

NCT: NCT07523308 · OBGynFudanU-2026-LUMEN 01 · SHDC12025134

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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