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

NCT07523308 | Not Yet Recruiting

• 2 other identifiers: OBGynFudanU-2026-LUMEN 01SHDC12025134
• Study Type: interventional
• Target: 192
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Bowel Endometriosis; Endometriosis; Intestinal Endometriosis

Keywords

Bowel Endometriosis; Intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR); Efficacy; Safety; LARS

Outcome Measures

Primary Outcomes (1)

• 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: 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 and often require prof

  baseline, and 6 months after bowel surgery

Secondary Outcomes (11)

• 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 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

Study Arms (2)

CL group

ACTIVE COMPARATOR

Participants in this group will undergo standard laparoscopic surgery for the localization, observation, and resection of bowel endometriosis lesions.

Procedure: conventional laparoscopy group

IDLnR group

EXPERIMENTAL

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

Interventions

conventional laparoscopy group PROCEDURE

Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically.

CL group

intra-operative Dual Laparoscopy and Neo-rectoscopy PROCEDURE

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.

IDLnR group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Gender Eligibility Description: Given the pathological characteristics of endometriosis, which arises from the ectopic growth of endometrial tissue and is closely associated with the female reproductive system, participation in this study is based on biological sex (individuals assigned female at birth, AFAB), which is a necessary premise for the occurrence of endometriosis. Therefore, eligibility to participate in the study (based on biological sex) is limited by gender identity to a certain extent. Eligible self-identified genders include all self-identified genders (e.g., cisgender women, transgender men, non-binary individuals), provided that the participants were assigned female at birth (AFAB) and have a confirmed diagnosis of bowel endometriosis. There is no exclusion of any self-identified gender as long as the core criterion of being assigned female at birth (the biological basis for endometriosis) is met.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Obstetrics & Gynecology Hospital of Fudan University: lead

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Model Details: 1. Study Design: a multicenter, open-label, parallel-group randomized controlled trial (RCT) conducted by three tertiary medical centers. Eligible patients will be randomly assigned in a 1:1 ratio to receive either the double-scope group (Intra-operative Dual Laparoscopy and Neo-rectoscopy, IDLnR) technique or conventional laparoscopy (CL). The primary endpoint is the rate of improvement in the Low Anterior Resection Syndrome (LARS) score category at 6 months after intestinal surgery. 2. Case Grouping Control group: Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically. Intervention group: 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.

Study Record Dates

• First Submitted: April 4, 2026
• First Posted: April 13, 2026
• Study Start: April 25, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04