[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633178":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":89,"collaborators":26,"id":91,"slug":26,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":26,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":70,"whyStopped":26,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Obstetrics & Gynecology Hospital of Fudan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"CL group","ACTIVE_COMPARATOR","Participants in this group will undergo standard laparoscopic surgery for the localization, observation, and resection of bowel endometriosis lesions.",[13],"Procedure: conventional laparoscopy group",{"label":15,"type":16,"description":17,"interventionNames":18},"IDLnR group","EXPERIMENTAL","The experimental group receives the novel IDLnR technique. The procedure begins with conventional laparoscopic exploration, followed by intra-operative neo-rectoscopy to check for mucosal involvement and identify lesion locations. After dual visualization, precise resection of bowel lesions is performed laparoscopically.",[19],"Procedure: intra-operative Dual Laparoscopy and Neo-rectoscopy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","conventional laparoscopy group","Underwent localization, observation and resection of bowel lesions using conventional laparoscopy (CL). The surgery for bowel endometriosis was completed laparoscopically.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"intra-operative Dual Laparoscopy and Neo-rectoscopy","Underwent localization, observation and resection of bowel lesions using intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR). The surgery for bowel endometriosis was completed laparoscopically.",[15],[32],{"name":33,"affiliation":5,"role":34},"Xiaofang Yi","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Xiaofang Yi, MD","CONTACT","+86 21 33189900","yix@fudan.edu.cn",{"name":42,"role":38,"phone":39,"phoneExt":43,"email":44},"Kai-kai Chang, MD","+86 1522169387","changkk@fudan.edu.cn",[46,68,75],{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"International Peace Maternity and Child Health Hospital","NOT_YET_RECRUITING","Shanghai","Shanghai Municipality","200030","China","CN",{"type":55,"coordinates":56},"Point",[57,58],121.45806,31.22222,{"lat":58,"lon":57},[61,65],{"name":62,"role":38,"phone":63,"phoneExt":26,"email":64},"Feng Sun, MD","+86 13585621594","sunfeng0711@126.com",{"name":66,"role":38,"phone":26,"phoneExt":26,"email":67},"Jing Ouyang, MD","ouyangjing126@126.com",{"facility":69,"status":70,"city":49,"state":50,"zip":71,"country":52,"countryCode":53,"cosmosGeoPoint":72,"geoPoint":74,"contacts":26},"Obstetrics and Gynecology Hospital of Fudan University","RECRUITING","201101",{"type":55,"coordinates":73},[57,58],{"lat":58,"lon":57},{"facility":76,"status":48,"city":49,"state":50,"zip":71,"country":52,"countryCode":53,"cosmosGeoPoint":77,"geoPoint":79,"contacts":80},"Shanghai First Maternity and Infant Hospital",{"type":55,"coordinates":78},[57,58],{"lat":58,"lon":57},[81,85],{"name":82,"role":38,"phone":83,"phoneExt":26,"email":84},"Shuangdi Li, MD","+86 15921664530","lishuangdi21@126.com",{"name":86,"role":38,"phone":87,"phoneExt":26,"email":88},"Yu Li, Master","+86 18049920519","liyu19831221@126.com",{"type":34,"investigatorFullName":33,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Chief Physician","100633178",false,"NCT07523308","Efficacy and Safety of Intra-operative Dual Laparoscopy and Neo-rectoscopy for Bowel Endometriosis: The LUMEN-01 Trial","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)","LUMEN-01","Inclusion Criteria:\n\n* Premenopausal women aged 18 to 55 years.\n* Preoperative pelvic contrast-enhanced MRI and\u002For transrectal endosonography confirmed bowel endometriosis (BE) lesions involving the muscular layer of the intestinal wall, located in the rectum and\u002For sigmoid colon. Postoperative pathological diagnosis serves as the gold standard.\n* Pre-treatment LARS score \\> 20.\n* Eligible for laparoscopic surgery.\n* Voluntarily participated in this study and signed written informed consent\n\nExclusion Criteria:\n\n* Pregnancy or lactation.\n* Presence of active inflammatory bowel disease, irritable bowel syndrome, or other similar conditions with disease flare-ups within the past 1 year.\n* Acute or severe infectious disease within 4 weeks prior to surgery.\n* History of malignant tumor, or highly suspected gynecological\u002Fgastrointestinal malignancy based on preoperative imaging or tumor marker tests.\n* 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.\n* Undergoing robot-assisted laparoscopic surgery or open laparotomy.\n* Currently participating in other clinical trials that may affect the outcome assessment of this study.\n* Previous participation in other interventional clinical trials that may affect the outcome assessment of this study.\n* History of colorectal resection and anastomosis or stoma surgery.\n* History of pelvic radiotherapy.","FEMALE","18 Years","55 Years",{"count":102,"type":103},192,"ESTIMATED","INTERVENTIONAL",[106],"NA","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.\n\nThe main questions it aims to answer are:\n\nIs 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\u002Fcure rate\u002Fimprovement 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.\n\nParticipants 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.\n\nThis 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.",[109,110,111],"Bowel Endometriosis","Endometriosis","Intestinal Endometriosis",[109,113,114,115,116],"Intra-operative Dual Laparoscopy and Neo-rectoscopy (IDLnR)","Efficacy","Safety","LARS","2026-05-16",{"date":119,"type":120},"2026-05-19","ACTUAL",{"date":122,"type":120},"2026-04-13",{"date":124,"type":103},"2028-05-31",{"name":5,"class":6},3]