[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100477290":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":24,"centralContacts":24,"locations":27,"responsibleParty":47,"collaborators":24,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":24,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":24,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":24,"overallStatus":30,"whyStopped":24,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Shanghai Minimally Invasive Surgery Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NOSES VIIIA","EXPERIMENTAL","totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction",[13],"Procedure: NOSES VIIIA",{"label":15,"type":16,"description":17,"interventionNames":18},"laparoscopic surgery with mini-laparotomy","ACTIVE_COMPARATOR","laparoscopic right hemicolectomy with trans-abdominal extraction from a mini-laparotomy",[19],"Procedure: laparoscopic surgery with mini-laparotomy",[21,25],{"type":22,"name":9,"description":11,"armGroupLabels":23,"otherNames":24},"PROCEDURE",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":26,"otherNames":24},[15],[28],{"facility":29,"status":30,"city":31,"state":24,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Ruijin Hospital","RECRUITING","Shanghai","200025","China","CN",{"type":36,"coordinates":37},"Point",[38,39],121.45806,31.22222,{"lat":39,"lon":38},[42],{"name":43,"role":44,"phone":45,"phoneExt":24,"email":46},"Zhenghao Cai","CONTACT","+862164458887","c3z2h1@alumni.sjtu.edu.cn",{"type":48,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Cai Zhenghao","Dr.","100477290","transvaginal-noses-versus-conventional-laparoscopic-surgery-for-right-hemicolectomy-100477290",false,"NCT05495048","Transvaginal NOSES Versus Conventional Laparoscopic Surgery for Right Hemicolectomy","Transvaginal Natural Orifice Specimen Extraction Surgery Versus Conventional Laparoscopic Surgery With Mini-laparotomy in Right Hemicolectomy for Colon Cancer: a Randomised, Controlled, Phase 3, Non-inferiority Trial (NOSES VIIIA Trial)","Inclusion Criteria:\n\n* volunteer to participate and the informed consent signed;\n* 18-75 years;\n* female who have given birth;\n* pathologically confirmed adenocarcinoma\u002Fhigh-grade intraepithelial neoplasia by preoperative colonoscopy and biopsy;\n* preoperative CT or MRI indicates that the tumor diameter is no more than 5.0 cm;\n* preoperative staging cT1-3NanyM0\n* body mass index \\\u003C30 kg\u002Fm2;\n* willing to undergo laparoscopic right hemicolectomy\n\nExclusion Criteria:\n\n* contraindications for laparoscopic surgery;\n* emergency surgery due to acute intestinal obstruction, perforation or bleeding;\n* distant metastasis;\n* multiple colorectal cancer;\n* has received preoperative chemoradiotherapy;\n* with a history of other malignant tumors;\n* unwilling to sign the informed consent or receive follow-up according to the study protocol.","FEMALE","18 Years","75 Years",{"count":62,"type":63},356,"ESTIMATED","INTERVENTIONAL",[66],"NA","It is controversial that totally laparoscopic right hemicolectomy with transvaginal natural orifice specimen extraction (NOSES VIIIA) can provide non-inferior oncological outcomes compared to conventional laparoscopic surgery with mini-laparotomy in the treatment of right colon cancer. We aim to carry out a multicenter, open-lable, parallel, non-inferiority, phase III, randomized controlled clinical trial, which enrolls 356 female patients with cT1-3NxM0 right colon adenocarcinoma. They are randomly assigned to the experimental group (NOSES VIIIA) or the control group (laparoscopic surgery with mini-laparotomy) in a 1:1 ratio. Perioperative indicators, pathological results, quality of life and cosmetic evaluation will be compared between the two groups. Then, a three-year follow-up of these patients will provide evidence for long-term oncological outcomes of NOSES VIIIA.",[69],"Colon Cancer","2024-02-22",{"date":72,"type":73},"2024-02-26","ACTUAL",{"date":75,"type":73},"2023-07-01",{"date":77,"type":63},"2028-12-31",{"name":5,"class":6},1]