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

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• Endometriosis 899

Keywords

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

Study arms

• Active comparator
  CL group

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

  Procedure: conventional laparoscopy group

• 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.

  Procedure: intra-operative Dual Laparoscopy and Neo-rectoscopy

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.

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.

   Time frame: baseline, and 6 months after bowel surgery

Secondary outcomes

1. LARS cure rate (LARS grade improved to no LARS at 12 months postoperatively)

   The LARS cure rate is defined as the proportion of patients whose LARS grade improves to the "No LARS" category (with a LARS score of 0-20) at 12 months postoperatively. Specifically, it refers to the percentage of patients who achieve normal bowel function, with no significant defecation-related distress and no impact on daily life or social activities, as evaluated by the LARS questionnaire at the 12-month follow-up.

   Time frame: baseline, and 12 months postoperatively

2. LARS improvement rate (decrease in LARS grade at 3 and 12 months postoperatively)

   The LARS improvement rate is defined as the proportion of patients who experience a decrease in LARS grade at 3 and 12 months postoperatively. Specifically, it refers to patients whose LARS grade is reduced from their preoperative grade (e.g., from Major LARS to Minor LARS, from Major LARS to No LARS, or from Minor LARS to No LARS) as evaluated by the LARS questionnaire at the 3-month and 12-month postoperative follow-ups.

   Time frame: baseline, 3 and 12 months postoperatively

3. Change in LARS score (changes from baseline at 3, 6, and 12 months postoperatively)

   The change in LARS score is defined as the difference in LARS scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 3, 6, and 12 months postoperatively. Specifically, it refers to the numerical change in LARS scores obtained from the LARS questionnaire, reflecting the degree of change in bowel function-related symptoms from the patient's preoperative state to each follow-up time point (3, 6, and 12 months after surgery). Minimum score: 0 Maximum score: 42 Interpretation: Higher scores indicate worse intestinal and defecatory function; lower scores indicate better function.

   Time frame: baseline, 3, 6, and 12 months postoperatively

4. Change in Colorectal Anal Distress Inventory-8 (CRADI-8) score (change from baseline at 6 months postoperatively)

   The change in Colorectal Anal Distress Inventory-8 (CRADI-8) score is defined as the difference in CRADI-8 scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 6 months postoperatively. Specifically, it refers to the numerical change in CRADI-8 scores obtained from the CRADI-8 questionnaire, reflecting the degree of change in colorectal and anal distress symptoms from the patient's preoperative state to the 6-month postoperative follow-up. Minimum score: 0 Maximum score: 100 Interpretation: Higher scores indicate more severe colorectal-anal distress symptoms; lower scores indicate milder symptoms.

   Time frame: baseline, and 6 months postoperatively

5. Change in Wexner constipation score (change from baseline at 12 months postoperatively)

   The change in Wexner constipation score is defined as the difference in Wexner constipation scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 12 months postoperatively. Specifically, it refers to the numerical change in Wexner constipation scores obtained from the relevant assessment tool, reflecting the degree of change in constipation-related symptoms from the patient's preoperative state to the 12-month postoperative follow-up. Minimum score: 0 Maximum score: 30 Interpretation: Higher scores indicate more severe constipation symptoms; lower scores indicate milder constipation.

   Time frame: baseline, 12 months postoperatively

6. Change in Gastrointestinal Quality of Life Index (GIQLI) score (changes from baseline at 6 and 12 months postoperatively).

   The change in Gastrointestinal Quality of Life Index (GIQLI) score is defined as the difference in GIQLI scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 6 and 12 months postoperatively. Specifically, it refers to the numerical change in GIQLI scores obtained from the GIQLI questionnaire, reflecting the degree of change in gastrointestinal-related quality of life from the patient's preoperative state to the 6-month and 12-month postoperative follow-ups. Minimum score: 0 Maximum score: 144 Interpretation: Higher scores indicate better gastrointestinal quality of life; lower scores indicate poorer quality of life.

   Time frame: baseline, 6 and 12 months postoperatively

7. Change in Endometriosis Health Profile-30 (EHP-30) score (changes from baseline at 6 and 12 months postoperatively)

   The change in Endometriosis Health Profile-30 (EHP-30) score is defined as the difference in EHP-30 scores between the postoperative follow-up and the baseline (preoperative) assessment, evaluated at 6 and 12 months postoperatively. Specifically, it refers to the numerical change in EHP-30 scores obtained from the EHP-30 questionnaire, reflecting the degree of change in endometriosis-related health status from the patient's preoperative state to the 6-month and 12-month postoperative follow-ups. Minimum score: 0 Maximum score: 100 Interpretation: Higher scores indicate worse symptoms and poorer health-related quality of life; lower scores indicate better health status.

   Time frame: baseline, 6 and 12 months postoperatively

8. Proportion of patients with ≥ 50% reduction in Visual Analogue Scale (VAS) score at 6 months postoperatively compared with baseline.

   The proportion of patients with a ≥ 50% reduction in Visual Analogue Scale (VAS) score at 6 months postoperatively compared with baseline is defined as the percentage of patients whose VAS score decreases by 50% or more at the 6-month postoperative follow-up relative to their preoperative (baseline) VAS score. It reflects the proportion of patients with significant improvement in pain-related symptoms. Minimum score: 0 Maximum score: 10 Interpretation: Higher scores indicate more severe pain; lower scores indicate milder or no pain.

   Time frame: baseline, and 6 months postoperatively

9. Incidence of severe complications within 30 days postoperatively

   The incidence of severe complications within 30 days postoperatively refers to the proportion of patients who experience severe complications within 30 days after surgery. These severe complications include intestinal perforation, intestinal anastomotic leakage/fistula, and intestinal bleeding, which are defined as events with a Clavien-Dindo classification of ≥ Grade III. Specifically, it refers to the percentage of patients who develop any of the aforementioned severe complications within 30 days after surgery, where the complications meet the criteria of Clavien-Dindo classification ≥ Grade III.

   Time frame: within 30 days postoperatively

10. Antibiotic Use Intensity within 7 days postoperatively

    Definition and scope: Only therapeutic antibiotics initiated or continued postoperatively due to fever are included. The study period is defined as postoperative days 0-7. Calculation of therapeutic antibiotic DDDs: Total DDDs = Σ (Total consumption of each antibiotic in g / WHO-DDD value of that antibiotic in g). Total consumption of each antibiotic (g) = Single dose (g) × Times per day × Duration of therapy (days).

    Time frame: 0-7 days postoperatively

11. Proportion of patients with postoperative hospital stay > 7 days

    The proportion of patients with postoperative hospital stay \> 7 days is defined as the percentage of patients whose length of hospital stay after surgery exceeds 7 days. Specifically, it refers to the proportion of participants whose total hospital stay from the time of surgery to discharge is longer than 7 days, reflecting the proportion of patients with prolonged postoperative hospitalization.

    Time frame: 30 days postoperatively

Study documents

• Protocol and statistical analysis plan · Apr 13, 2026
• Informed consent form · Feb 28, 2026

Documents are hosted by the registry — open the source record to download them.