RecruitingNot ApplicableNCT07523308

Efficacy and Safety of Intra-operative Dual Laparoscopy and Neo-rectoscopy 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)


Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Enrollment

192 participants

Start Date

Apr 13, 2026

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called conventional laparoscopy group and a procedure called intra-operative Dual Laparoscopy and Neo-rectoscopy for people with bowel endometriosis, endometriosis, and other related conditions. The study is currently recruiting participants at 3 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREconventional laparoscopy group

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

PROCEDUREintra-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.


Locations(3)

International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, China

Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai First Maternity and Infant Hospital

Shanghai, Shanghai Municipality, China

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NCT07523308


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