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

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)

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.

Study Overview

• Status: Recruiting
• Conditions: Endometriosis; Bowel Endometriosis; Intestinal Endometriosis
• Intervention / Treatment: Procedure: conventional laparoscopy group; Procedure: intra-operative Dual Laparoscopy and Neo-rectoscopy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 192
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaofang Yi, MD; Phone Number: +86 21 33189900; Email: yix@fudan.edu.cn
• Study Contact Backup: Name: Kai-kai Chang, MD; Phone Number: +86 1522169387 +86 21 33189900; Email: changkk@fudan.edu.cn

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200030
      • Not yet recruiting
      • International Peace Maternity and Child Health Hospital
      • Contact: Feng Sun, MD; Phone Number: +86 13585621594; Email: sunfeng0711@126.com
      • Contact: Jing Ouyang, MD; Email: ouyangjing126@126.com
    • Shanghai, Shanghai Municipality, China, 201101
      • Recruiting
      • Obstetrics and Gynecology Hospital of Fudan University
    • Shanghai, Shanghai Municipality, China, 201101
      • Not yet recruiting
      • Shanghai First Maternity and Infant Hospital
      • Contact: Shuangdi Li, MD; Phone Number: +86 15921664530; Email: lishuangdi21@126.com
      • Contact: Yu Li, Master; Phone Number: +86 18049920519; Email: liyu19831221@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CL group; Participants in this group will undergo standard laparoscopic surgery for the localization, observation, and resection of bowel endometriosis lesions.	Procedure: conventional laparoscopy group; Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically.
Experimental: 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.	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The improvement rate of the Low Anterior Resection Syndrome (LARS) score grade at 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: No LARS: score 0-20; normal bowel function with no significant defecation-related distress and no impact on daily life or social activities.; 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.; 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.	baseline, and 6 months after bowel surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LARS cure rate (LARS grade improved to no LARS at 12 months postoperatively)	The LARS cure rate is defined as the proportion of patients whose LARS grade improves to the "No LARS" category (with a LARS score of 0-20) at 12 months postoperatively. Specifically, it refers to the percentage of patients who achieve normal bowel function, with no significant defecation-related distress and no impact on daily life or social activities, as evaluated by the LARS questionnaire at the 12-month follow-up.	baseline, and 12 months postoperatively
LARS improvement rate (decrease in LARS grade at 3 and 12 months postoperatively)	The LARS improvement rate is defined as the proportion of patients who experience a decrease in LARS grade at 3 and 12 months postoperatively. Specifically, it refers to patients whose LARS grade is reduced from their preoperative grade (e.g., from Major LARS to Minor LARS, from Major LARS to No LARS, or from Minor LARS to No LARS) as evaluated by the LARS questionnaire at the 3-month and 12-month postoperative follow-ups.	baseline, 3 and 12 months postoperatively
Incidence of severe complications within 30 days postoperatively	The incidence of severe complications within 30 days postoperatively refers to the proportion of patients who experience severe complications within 30 days after surgery. These severe complications include intestinal perforation, intestinal anastomotic leakage/fistula, and intestinal bleeding, which are defined as events with a Clavien-Dindo classification of ≥ Grade III. Specifically, it refers to the percentage of patients who develop any of the aforementioned severe complications within 30 days after surgery, where the complications meet the criteria of Clavien-Dindo classification ≥ Grade III.	within 30 days postoperatively
Antibiotic Use Intensity within 7 days postoperatively	Definition and scope: Only therapeutic antibiotics initiated or continued postoperatively due to fever are included. The study period is defined as postoperative days 0-7. Calculation of therapeutic antibiotic DDDs: Total DDDs = Σ (Total consumption of each antibiotic in g / WHO-DDD value of that antibiotic in g). Total consumption of each antibiotic (g) = Single dose (g) × Times per day × Duration of therapy (days).	0-7 days postoperatively
Proportion of patients with postoperative hospital stay > 7 days	The proportion of patients with postoperative hospital stay > 7 days is defined as the percentage of patients whose length of hospital stay after surgery exceeds 7 days. Specifically, it refers to the proportion of participants whose total hospital stay from the time of surgery to discharge is longer than 7 days, reflecting the proportion of patients with prolonged postoperative hospitalization.	30 days postoperatively
Change in LARS score (changes from baseline at 3, 6, and 12 months postoperatively)	The change in LARS score is defined as the difference in LARS scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 3, 6, and 12 months postoperatively. Specifically, it refers to the numerical change in LARS scores obtained from the LARS questionnaire, reflecting the degree of change in bowel function-related symptoms from the patient's preoperative state to each follow-up time point (3, 6, and 12 months after surgery). Minimum score: 0 Maximum score: 42 Interpretation: Higher scores indicate worse intestinal and defecatory function; lower scores indicate better function.	baseline, 3, 6, and 12 months postoperatively
Change in Colorectal Anal Distress Inventory-8 (CRADI-8) score (change from baseline at 6 months postoperatively)	The change in Colorectal Anal Distress Inventory-8 (CRADI-8) score is defined as the difference in CRADI-8 scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 6 months postoperatively. Specifically, it refers to the numerical change in CRADI-8 scores obtained from the CRADI-8 questionnaire, reflecting the degree of change in colorectal and anal distress symptoms from the patient's preoperative state to the 6-month postoperative follow-up. Minimum score: 0 Maximum score: 100 Interpretation: Higher scores indicate more severe colorectal-anal distress symptoms; lower scores indicate milder symptoms.	baseline, and 6 months postoperatively
Change in Wexner constipation score (change from baseline at 12 months postoperatively)	The change in Wexner constipation score is defined as the difference in Wexner constipation scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 12 months postoperatively. Specifically, it refers to the numerical change in Wexner constipation scores obtained from the relevant assessment tool, reflecting the degree of change in constipation-related symptoms from the patient's preoperative state to the 12-month postoperative follow-up. Minimum score: 0 Maximum score: 30 Interpretation: Higher scores indicate more severe constipation symptoms; lower scores indicate milder constipation.	baseline, 12 months postoperatively
Change in Gastrointestinal Quality of Life Index (GIQLI) score (changes from baseline at 6 and 12 months postoperatively).	The change in Gastrointestinal Quality of Life Index (GIQLI) score is defined as the difference in GIQLI scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 6 and 12 months postoperatively. Specifically, it refers to the numerical change in GIQLI scores obtained from the GIQLI questionnaire, reflecting the degree of change in gastrointestinal-related quality of life from the patient's preoperative state to the 6-month and 12-month postoperative follow-ups. Minimum score: 0 Maximum score: 144 Interpretation: Higher scores indicate better gastrointestinal quality of life; lower scores indicate poorer quality of life.	baseline, 6 and 12 months postoperatively
Change in Endometriosis Health Profile-30 (EHP-30) score (changes from baseline at 6 and 12 months postoperatively)	The change in Endometriosis Health Profile-30 (EHP-30) score is defined as the difference in EHP-30 scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 6 and 12 months postoperatively. Specifically, it refers to the numerical change in EHP-30 scores obtained from the EHP-30 questionnaire, reflecting the degree of change in endometriosis-related health status from the patient's preoperative state to the 6-month and 12-month postoperative follow-ups. Minimum score: 0 Maximum score: 100 Interpretation: Higher scores indicate worse symptoms and poorer health-related quality of life; lower scores indicate better health status.	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.	The proportion of patients with a ≥ 50% reduction in Visual Analogue Scale (VAS) score at 6 months postoperatively compared with baseline is defined as the percentage of patients whose VAS score decreases by 50% or more at the 6-month postoperative follow-up relative to their preoperative (baseline) VAS score. It reflects the proportion of patients with significant improvement in pain-related symptoms. Minimum score: 0 Maximum score: 10 Interpretation: Higher scores indicate more severe pain; lower scores indicate milder or no pain.	baseline, and 6 months postoperatively

Collaborators and Investigators

• Sponsor: Obstetrics & Gynecology Hospital of Fudan University
• Investigators: Principal Investigator: Xiaofang Yi, Obstetrics & Gynecology Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): April 13, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 4, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 16, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Safety; Efficacy; LARS; Bowel Endometriosis; Intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: OBGynFudanU-2026-LUMEN 01; SHDC12025134 (Other Grant/Funding Number: Shanghai Shenkang Hospital Development Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No