NCT07523308Recruiting
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)
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 192 (estimated)
- First submitted
- 4 Apr 2026
- Start date
- 13 Apr 2026
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Diseases
- Endometriosis
- NCT number
- NCT07523308
What you commit to
- Study type: Interventional
- Planned participants: 192
- From 13 Apr 2026 to the primary completion date, 30 Nov 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute or severe infectious disease within 4 weeks prior to surgery.
- Undergoing robot-assisted laparoscopic surgery or open laparotomy.
- Previous participation in other interventional clinical trials that may affect the outcome assessment of this study.
Other illness
- Presence of active inflammatory bowel disease, irritable bowel syndrome, or other similar conditions with disease flare-ups within the past 1 year.
- History of malignant tumor, or highly suspected gynecological/gastrointestinal malignancy based on preoperative imaging or tumor marker tests.
- American Society of Anesthesiologists (ASA) physical status classification ≥ Grade Ⅲ, or severe cardiac, pulmonary, hepatic, renal, or coagulation dysfunction that precludes general anesthesia and elective laparoscopic surgery.
- History of colorectal resection and anastomosis or stoma surgery.
- History of pelvic radiotherapy.
Other
- Pregnancy or lactation.
- Currently participating in other clinical trials that may affect the outcome assessment of this study.
Who the study is looking for
- Premenopausal women aged 18 to 55 years.
- Preoperative pelvic contrast-enhanced MRI and/or transrectal endosonography confirmed bowel endometriosis (BE) lesions involving the muscular layer of the intestinal wall, located in the rectum and/or sigmoid colon. Postoperative pathological diagnosis serves as the gold standard.
- Pre-treatment LARS score \> 20.
- Eligible for laparoscopic surgery.
- Voluntarily participated in this study and signed written informed consent
Age in the registry: 18 years to 55 years · Sex: Female · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| International Peace Maternity and Child Health Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
| Obstetrics and Gynecology Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai First Maternity and Infant Hospital Coordinator of this site? Confirm its status | Shanghai | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.