Trial studying safety and effects for Bowel Endometriosis
Official title Efficacy and Safety of Intra-operative Dual Laparoscopy and Neo-rectoscopy for Bowel Endometriosis: The LUMEN-01 Trial
ClinicalTrials.gov ID: NCT07523308
What this study is testing
- What it's testing
- The study compares how well each surgery improves bowel function after 6 months and looks at other outcomes like pain, quality of life, and safety.
- Who it's for
- Women who have bowel endometriosis and are scheduled for surgery.
- What's involved
- Participants will be randomly assigned to receive either the new IDLnR surgery or the usual laparoscopy. After surgery, they will have follow‑up visits to check bowel function, pain, and other health measures.
- Time commitment
- The study lasts about 6 months after surgery, with follow‑up visits at 6 months to assess outcomes.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55, women only
You may be able to join if
- 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...
- Pre-treatment LARS score \> 20.
- Eligible for laparoscopic surgery.
- Voluntarily participated in this study and signed written informed consent
You likely can't join if
- 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...
- Undergoing robot-assisted laparoscopic surgery or open laparotomy.
See the full eligibility 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.
- Pre-treatment LARS score \> 20.
- Eligible for laparoscopic surgery.
- Voluntarily participated in this study and signed written informed consent
- 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...
- 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 treatment clinical trials that may affect the outcome assessment of this study.
- History of colorectal resection and anastomosis or stoma surgery.
- History of pelvic radiotherapy.
The study team makes the final eligibility decision.
Where it is enrolling
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.