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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)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
International Peace Maternity and Child Health Hospital
NOT_YET_RECRUITING
Shanghai
Obstetrics and Gynecology Hospital of Fudan University
RECRUITING
Shanghai
Shanghai First Maternity and Infant Hospital
NOT_YET_RECRUITING
Shanghai
Contact Information
Primary
Xiaofang Yi, MD
yix@fudan.edu.cn
+86 21 33189900
Backup
Kai-kai Chang, MD
changkk@fudan.edu.cn
+86 21 33189900
Time Frame
Start Date: 2026-04-13
Estimated Completion Date: 2028-05-31
Participants
Target number of participants: 192
Treatments
Active_comparator: CL group
Participants in this group will undergo standard laparoscopic surgery for the localization, observation, and resection of bowel endometriosis lesions.
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.
Related Therapeutic Areas
Sponsors
Leads: Obstetrics & Gynecology Hospital of Fudan University

This content was sourced from clinicaltrials.gov