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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 192
- 试验地点
- 3
- 主要终点
- The improvement rate of the Low Anterior Resection Syndrome (LARS) score grade at 6 months after bowel surgery.
研究概览
简要总结
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.
详细描述
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:
- To evaluate the incidence of complications and severe complications within 30 days postoperatively in both groups, including anastomotic leakage, intestinal injury, intestinal bleeding, etc.
- To evaluate changes in postoperative pain relief, gastrointestinal function, and quality of life between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the nature of surgical intervention, blinding of surgeons and patients was not feasible. However, outcome assessors and data analysts remained blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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 >
- •Eligible for laparoscopic surgery.
- •Voluntarily participated in this study and signed written informed consent
排除标准
- •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.
研究组 & 干预措施
CL group
Participants in this group will undergo standard laparoscopic surgery for the localization, observation, and resection of bowel endometriosis lesions.
干预措施: conventional laparoscopy group (Procedure)
IDLnR group
The experimental group receives the novel IDLnR technique. The procedure begins with conventional laparoscopic exploration, followed by intra-operative neo-rectoscopy to check for mucosal involvement and identify lesion locations. After dual visualization, precise resection of bowel lesions is performed laparoscopically.
干预措施: intra-operative Dual Laparoscopy and Neo-rectoscopy (Procedure)
结局指标
主要结局
The improvement rate of the Low Anterior Resection Syndrome (LARS) score grade at 6 months after bowel surgery.
时间窗: baseline, and 6 months after bowel surgery
Improvement was defined as a change in LARS grade at 6 months postoperatively from severe LARS to mild LARS or no LARS, or from mild LARS to no LARS. The LARS score was obtained using the LARS questionnaire. The definitions of each LARS grade are as follows: 1. No LARS: score 0-20; normal bowel function with no significant defecation-related distress and no impact on daily life or social activities. 2. Minor LARS: score 21-29; presence of symptoms such as flatus or fecal incontinence, increased stool frequency, or urgency, but mild in severity. These symptoms are largely controllable through dietary modification and bowel habit adjustment, with limited impact on quality of life. 3. Major LARS: score 30-42; severe symptoms including frequent fecal incontinence, intractable severe urgency, and cluster defecation, which significantly interfere with daily activities, social life, and psychological status.
次要结局
- LARS cure rate (LARS grade improved to no LARS at 12 months postoperatively)(baseline, and 12 months postoperatively)
- LARS improvement rate (decrease in LARS grade at 3 and 12 months postoperatively)(baseline, 3 and 12 months postoperatively)
- Change in Gastrointestinal Quality of Life Index (GIQLI) score (changes from baseline at 6 and 12 months postoperatively).(baseline, 6 and 12 months postoperatively)
- Incidence of severe complications within 30 days postoperatively(within 30 days postoperatively)
- Antibiotic Use Intensity within 7 days postoperatively(0-7 days postoperatively)
- Proportion of patients with postoperative hospital stay > 7 days(30 days postoperatively)
- Change in LARS score (changes from baseline at 3, 6, and 12 months postoperatively)(baseline, 3, 6, and 12 months postoperatively)
- Change in Colorectal Anal Distress Inventory-8 (CRADI-8) score (change from baseline at 6 months postoperatively)(baseline, and 6 months postoperatively)
- Change in Wexner constipation score (change from baseline at 12 months postoperatively)(baseline, 12 months postoperatively)
- Change in Endometriosis Health Profile-30 (EHP-30) score (changes from baseline at 6 and 12 months postoperatively)(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.(baseline, and 6 months postoperatively)
研究者
Xiaofang Yi
Chief Physician
Obstetrics & Gynecology Hospital of Fudan University