Intra-operative dual laparoscopy and neo-rectoscopy (IDLnR) versus conventional laparoscopy for bowel endometriosis
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)
NA · Obstetrics & Gynecology Hospital of Fudan University · NCT07523308
We will test whether adding intra-operative dual laparoscopy and neo-rectoscopy (IDLnR) to surgery for women with bowel endometriosis improves bowel function six months after the operation compared with conventional laparoscopy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 192 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Obstetrics & Gynecology Hospital of Fudan University (other) |
| Locations | 3 sites (Shanghai, Shanghai Municipality and 2 other locations) |
| Trial ID | NCT07523308 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter, randomized controlled trial enrolling premenopausal women with MRI or transrectal endosonography-confirmed bowel endometriosis of the rectum or sigmoid and a pre-treatment LARS score over 20. Participants are randomized to receive either intra-operative dual laparoscopy and neo-rectoscopy (IDLnR) or conventional laparoscopy (CL) during their bowel endometriosis surgery. The primary outcome is change in postoperative bowel function at six months, and secondary outcomes include 30-day complications, various symptom and quality-of-life scores (LARS cure/improvement rate, CRADI-8, Wexner, GIQLI, EHP-30, VAS), antibiotic use intensity, and length of hospital stay. Postoperative pathological diagnosis is used as the gold standard and outcomes are compared between the two groups.
Who should consider this trial
Good fit: Premenopausal women aged 18–55 with imaging-confirmed bowel endometriosis involving the muscular layer of the rectum or sigmoid, a pre-treatment LARS score >20, and who are eligible for laparoscopic surgery and able to give informed consent.
Not a fit: Pregnant or lactating women, patients with recent inflammatory bowel disease or active gastrointestinal infections, those with suspected malignancy, or patients with ASA physical status ≥III are excluded and unlikely to benefit from this surgical approach.
Why it matters
Potential benefit: If successful, IDLnR could improve bowel function six months after surgery and reduce complication-related setbacks for women undergoing surgery for bowel endometriosis.
How similar studies have performed: Dual-scope intraoperative techniques have shown promise in some colorectal surgical settings, but randomized evidence specifically testing IDLnR for bowel endometriosis is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Pregnancy or lactation. * Presence of active inflammatory bowel disease, irritable bowel syndrome, or other similar conditions with disease flare-ups within the past 1 year. * Acute or severe infectious disease within 4 weeks prior to surgery. * 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. * Undergoing robot-assisted laparoscopic surgery or open laparotomy. * Currently participating in other clinical trials that may affect the outcome assessment of this study. * Previous participation in other interventional clinical trials that may affect the outcome assessment of this study. * History of colorectal resection and anastomosis or stoma surgery. * History of pelvic radiotherapy.
Where this trial is running
Shanghai, Shanghai Municipality and 2 other locations
- International Peace Maternity and Child Health Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
- Obstetrics and Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
- Shanghai First Maternity and Infant Hospital — Shanghai, Shanghai Municipality, China (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Xiaofang Yi — Obstetrics & Gynecology Hospital of Fudan University
- Study coordinator: Xiaofang Yi, MD
- Email: yix@fudan.edu.cn
- Phone: +86 21 33189900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bowel Endometriosis, Endometriosis, Intestinal Endometriosis, Intra-operative Dual Laparoscopy and Neo-rectoscopy, Efficacy, Safety, LARS