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LUMEN-01
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Shanghai Shenkang Hospital Development Center
interventional
192
1 country
3
Study Start
April 13, 2026
Actual (reported)Primary Completion
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 4, 2026
Actual (reported)April 13, 2026
Actual (reported)April 13, 2026
Actual (reported)November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
baseline, and 6 months after bowel surgery
LARS cure rate (LARS grade improved to no LARS at 12 months postoperatively)
Participants in this group will undergo standard laparoscopic surgery for the localization, observation, and resection of bowel endometriosis lesions.
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.
Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically.
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.
International Peace Maternity and Child Health Hospital
Shanghai, Shanghai Municipality, 200030, China
Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 201101, China
Xiaofang Yi
Obstetrics & Gynecology Hospital of Fudan University
First Submitted
April 4, 2026
baseline, and 12 months postoperatively
LARS improvement rate (decrease in LARS grade at 3 and 12 months postoperatively)
baseline, 3 and 12 months postoperatively
Change in LARS score (changes from baseline at 3, 6, and 12 months postoperatively)
baseline, 3, 6, and 12 months postoperatively
Change in Colorectal Anal Distress Inventory-8 (CRADI-8) score (change from baseline at 6 months postoperatively)
baseline, and 6 months postoperatively
Change in Wexner constipation score (change from baseline at 12 months postoperatively)
baseline, 12 months postoperatively
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 201101, China
First Posted
April 13, 2026
Study Start
April 13, 2026
Actual (reported)Primary Completion
November 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
May 19, 2026
Record last verified: 2026-05
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Source: ClinicalTrials.gov.
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