[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562816":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":19,"centralContacts":20,"locations":26,"responsibleParty":45,"collaborators":19,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":49,"sex":55,"minAge":56,"maxAge":19,"enrollmentInfo":57,"targetDuration":19,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":29,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University Hospital, Clermont-Ferrand","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"Totale hysterectomy with indocyanine green and fluorescence intensity analysis","Patient scheduled to undergo total hysterectomy through a surgically accessible laparoscopic procedure.\n\nThe difference from standard care is that during the intraoperative period, at the end of the procedure, the patient will receive a diluted bolus of indocyanine green. The collected images will be analyzed using the TRACKER software in order to assess intraoperative vascularization of the area (fluorescence intensity value different from 0).",[12],"Diagnostic Test: indocyanine green injected intravenously",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DIAGNOSTIC_TEST","indocyanine green injected intravenously","During the procedure, after performing the hysterectomy, indocyanine green will be injected intravenously into the patient. A fluorescence video of the vaginal cuff will be recorded. The fluorescence of the recorded images will be analyzed by fluorescence analysis software to obtain an objective value of fluorescence.",[9],null,[21],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Lise Laclautre","CONTACT","+33 4 73 75 11 95","promo_interne_drci@chu-clermontferrand.fr",[27],{"facility":28,"status":29,"city":30,"state":19,"zip":19,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"CHU Clermont-Ferrand","RECRUITING","Clermont-Ferrand","France","FR",{"type":34,"coordinates":35},"Point",[36,37],3.08682,45.77969,{"lat":37,"lon":36},[40,42],{"name":22,"role":23,"phone":41,"phoneExt":19,"email":25},"04 73 75 11 95",{"name":43,"role":44,"phone":19,"phoneExt":19,"email":19},"Pauline CHAUVET","PRINCIPAL_INVESTIGATOR",{"type":46,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100562816","study-of-the-vascularization-of-the-vaginal-slice-after-total-laparoscopic-hysterectomy-using-indocyanine-green-injection-100562816",false,"NCT06608082","Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection.","Study of the Vascularization of the Vaginal Slice After Total Laparoscopic Hysterectomy, Using Indocyanine Green Injection. Prospective Feasibility Study","HYSTINDO","Inclusion Criteria:\n\n* Adult patient\n* Patient scheduled to undergo total hysterectomy through a surgically accessible laparoscopic procedure.\n* Patiente capable of providing informed consent to participate in the study.\n* Patiente covered by the Social Security system.\n\nExclusion Criteria:\n\n* Protected patient, under guardianship, curatorship or legal protection.\n* Patient's refusal or inadequate understanding of the French language.\n* Known allergy to iodine.\n* Ongoing pregnancy and breastfeeding.\n* Procedure requiring the use of indocyanine green.","FEMALE","18 Years",{"count":58,"type":59},90,"ESTIMATED","INTERVENTIONAL",[62],"NA","Hysterectomy is one of the most common surgical procedures in gynecology, especially by laparoscopy. Post-operative complications of hysterectomy are numerous and their causes are poorly understood.\n\nIndocyanine green is a fluorescent dye that, when exposed to infrared light, makes it possible to visualize the vascularization by fluorescence.\n\nThe project consists in studying the vascularization of the vaginal cuff after total laparoscopic hysterectomy using the injection of indocyanine green. This is a prospective feasibility study.\n\nDuring the procedure, after performing the hysterectomy, indocyanine green will be injected intravenously into the patient. A fluorescence video of the vaginal cuff will be recorded. The fluorescence of the recorded images will be analyzed by fluorescence analysis software to obtain an objective value of fluorescence. The fluorescence values will be compared to the occurrence or absence of postoperative complications.\n\nThis is the first study using this imaging technique combined with indocyanine green in this surgery. This study will employ a novel objective sequential fluorescence analysis software that has already proven its effectiveness in digestive surgery. The sequential measurement of the change in fluorescence intensity visualized in the images of laparoscopy will enable the production of vaginal perfusion graphs using a video modeling tool such as the TRACKER software. This software measures the evolution of green levels in a region of interest, from which a time-fluorescence curve can be obtained. The presence of fluorescence will be defined by a fluorescence intensity value of Fmax-Fmin on the graph.",[65,66,67],"Hysterectomy","Vascularization","Complication of Surgical Procedure",[69,70,71,72,73],"indocyanine green","laparoscopic hysterectomy","Post-operative complications of hysterectomy","TRACKER software","imaging technique","2024-09-20",{"date":76,"type":77},"2024-09-23","ACTUAL",{"date":79,"type":59},"2024-09-21",{"date":81,"type":59},"2025-11-30",{"name":5,"class":6},1]