Efficacy and Safety of Intra-operative Dual Laparoscopy and Neo-rectoscopy for Bowel Endometriosis: The LUMEN-01 Trial
Recruiting · NCT07523308 · Interventional (participants receive a specific treatment) · Lead sponsor: Obstetrics & Gynecology Hospital of Fudan University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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 it is running
3 locations listed.
- International Peace Maternity and Child Health Hospital - Shanghai, Shanghai Municipality, China
- Obstetrics and Gynecology Hospital of Fudan University - Shanghai, Shanghai Municipality, China
- Shanghai First Maternity and Infant Hospital - Shanghai, Shanghai Municipality, China