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

Recruiting N/A Interventional Study
Bowel Endometriosis Endometriosis Intestinal Endometriosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 55
Sex
Female
Study type
Interventional
Purpose
Treatment
Participants needed
192 (estimated)
Sponsor
Obstetrics & Gynecology Hospital of Fudan University · Other
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About This Trial
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 g…
Trial Locations
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Eligibility 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 path…
Contacts

Xiaofang Yi, MD

+86 21 33189900

yix@fudan.edu.cn

CONTACT

Kai-kai Chang, MD

+86 21 33189900

changkk@fudan.edu.cn

CONTACT