NCT07523308

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

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: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 192 (estimated)
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University · Academic / Other
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Bowel Endometriosis
• Endometriosis
• Intestinal Endometriosis

Interventions

Type	Name	Description
PROCEDURE	conventional laparoscopy group	Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed 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.

Timeline

• Start date: 2026-04-25
• Primary completion: 2027-11-30
• Completion: 2028-05-31
• First posted: 2026-04-13
• Last updated: 2026-04-13