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

Sponsor
Obstetrics & Gynecology Hospital of Fudan University
Study ID
NCT07523308
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

First listed
Apr 13, 2026
Start date
Apr 13, 2026
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

The improvement rate of the Low Anterior Resection Syndrome (LARS) score grade at 6 months after bowel surgery. [ Time Frame: baseline, and 6 months after bowel surgery ]

Central Contacts

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