Intra-operative dual laparoscopy and neo-rectoscopy (IDLnR) versus conventional laparoscopy for bowel endometriosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• Obstetrics and Gynecology Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting
• International Peace Maternity and Child Health Hospital
  Shanghai, Shanghai Municipality, China Not yet 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Comparing different techniques to treat endometriosis

  This study is testing different methods to treat endometriosis, like laser and heat techniques, to see which one works best for relieving pain in women who are already having surgery for the condition.

  Recruiting TriHealth Inc. · Cincinnati, Ohio · NCT06414083

• Postoperative Pain Trajectories After Endometriosis Surgery

  This study tests how pain changes after endometriosis surgery and whether perioperative pain testing can predict who will have ongoing pain.

  Recruiting Centre Hospitalier Universitaire, Amiens · Amiens · NCT07882498

• Imaging endometriosis with a special PET tracer in adult women

  This study tests whether a PET/CT scan using [18F]AlF-FAPI-74 can help detect endometriosis lesions in women who are planning laparoscopy.

  Recruiting Universitaire Ziekenhuizen KU Leuven · Leuven · NCT07876648

• Fiber supplement for digestive symptoms in endometriosis

  A fiber-based supplement is being tested to see if it is safe and helps with gut and vaginal microbiomes and digestive symptoms in women with endometriosis.

  Recruiting LOAM Science · San Francisco, California · NCT07875062

• Stellate ganglion block and dexmedetomidine for better sleep after gynecologic laparoscopy

  The study tests whether giving a preoperative stellate ganglion block plus intraoperative dexmedetomidine improves sleep after laparoscopic gynecologic surgery in women.

  Recruiting The Second People's Hospital of Huai'an · Huai'an, Jiangsu · NCT07860203

• Atypical Endometriosis: Histology, Immunophenotype and Molecular Features

  Researchers will look at how endometriotic tissue that looks atypical under the microscope relates to clinical features and ultrasound findings to better separate benign from potentially atypical lesions.

  Recruiting Casa di Cura Dott. Pederzoli · Peschiera del Garda, Verona · NCT07816133

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.