[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542888":3},{"organization":4,"armGroups":7,"interventions":48,"overallOfficials":54,"centralContacts":135,"locations":142,"responsibleParty":312,"collaborators":54,"id":314,"slug":315,"hasResults":316,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":316,"sex":322,"minAge":323,"maxAge":54,"enrollmentInfo":324,"targetDuration":54,"studyType":327,"phases":328,"briefSummary":330,"conditions":331,"keywords":54,"overallStatus":161,"whyStopped":54,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":342},{"fullName":5,"class":6},"Rennes University Hospital","OTHER",[8,31,37,42],{"label":9,"type":10,"description":11,"interventionNames":12},"Randomized study: Robot-assisted laparoscopy","EXPERIMENTAL","Robot-assisted laparoscopic hysterectomy",[13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30],"Procedure: Robot-assisted laparoscopy","Other: information and consent","Other: randomization","Other: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence","Other: Surgical data collection","Other: Biological data collection","Other: Collection of histological data from the surgical specimen","Other: Phone calls","Other: Pain assessment","Other: Collect of data on non-reimbursed transport","Other: Collect of everyday help","Other: Collection of the business resumption date","Other: SF36 questionnaire","Other: Questionnaire EQ5D-5L","Other: FIGO Stadium","Other: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)","Other: Collection of adjuvant treatments","Other: Recording of any complications, emergency room visits\u002Funscheduled consultations, additional work stoppages to the initial one",{"label":32,"type":33,"description":34,"interventionNames":35},"Randomized study: conventional laparoscopy","ACTIVE_COMPARATOR","Conventional laparoscopic hysterectomy",[36,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30],"Procedure: conventional laparoscopy",{"label":38,"type":6,"description":39,"interventionNames":40},"Prospective cohort study","Prospective cohort study backed by randomized controlled trial (for patients not included in the trial due to surgeon refusal, absence of learning curve criteria for the surgeon or patient refusal, center unable to participate in the randomized study).",[41,14,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30],"Other: Prospective cohort study",{"label":43,"type":6,"description":44,"interventionNames":45},"Retrospective cohort study","a retrospective cohort will be set up to provide an exhaustive overview of the approaches used for endometrial cancer, according to patient characteristics (age and BMI). It will include all patients not included in the randomized controlled trial and in the prospective cohort because the surgeon did not propose it to them, because they did not wish to be followed up for the study for 6 months, or because the surgeon considered that minimally invasive surgery was not indicated; up to a limit of 1000 inclusions.",[46,14,47],"Other: Retrospective cohort study","Other: Collection of data",[49,55,59,62,65,68,72,75,79,83,87,91,95,99,103,107,111,115,119,123,127,131],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"PROCEDURE","Robot-assisted laparoscopy","The experimental procedure corresponds to robot-assisted laparoscopy.",[9],null,{"type":50,"name":56,"description":57,"armGroupLabels":58,"otherNames":54},"conventional laparoscopy","The \"control\" procedure corresponds to conventional laparoscopy.",[32],{"type":6,"name":38,"description":60,"armGroupLabels":61,"otherNames":54},"A prospective cohort of patients will be set up to support the randomized controlled trial. Patients will be offered participation in this cohort if the center is unable to participate in the randomized trial (i.e., does not have a robot, or does not have a laparoscopic column with fluorescence), if the patient refuses randomization in the randomized controlled trial, if the surgeon refuses to randomize the patient, or if the surgeon does not meet the learning curve criteria required for robotic surgery. These patients will be followed in exactly the same way as patients included in the randomized controlled trial, once their consent has been obtained.",[38],{"type":6,"name":43,"description":63,"armGroupLabels":64,"otherNames":54},"Retrospective data collection from the medical records of all patients who underwent hysterectomy for low- or intermediate-risk endometrial cancer during the inclusion period at a participating center and who were not included in the randomized controlled trial or prospective cohort; up to a limit of 1000 inclusions. For this retrospective cohort, only data concerning initial age, BMI, histological type of cancer and surgical approach used will be collected.",[43],{"type":6,"name":66,"description":66,"armGroupLabels":67,"otherNames":54},"information and consent",[38,9,32,43],{"type":6,"name":69,"description":70,"armGroupLabels":71,"otherNames":54},"randomization","Randomization",[9,32],{"type":6,"name":73,"description":73,"armGroupLabels":74,"otherNames":54},"Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence",[38,9,32],{"type":6,"name":76,"description":77,"armGroupLabels":78,"otherNames":54},"Surgical data collection","Surgical data collection at Day 0",[38,9,32],{"type":6,"name":80,"description":81,"armGroupLabels":82,"otherNames":54},"Biological data collection","Biological data collection at Day 1",[38,9,32],{"type":6,"name":84,"description":85,"armGroupLabels":86,"otherNames":54},"Collection of histological data from the surgical specimen","Collection of histological data from the surgical specimen et Day 42",[38,9,32],{"type":6,"name":88,"description":89,"armGroupLabels":90,"otherNames":54},"Phone calls","Phone calls at Day 1, Day 3,Day 7,Day14,Day 21 , Month 3",[38,9,32],{"type":6,"name":92,"description":93,"armGroupLabels":94,"otherNames":54},"Pain assessment","Pain assessment at day 1 , Day 3,Day 7,Day14,Day 21 , Month 3",[38,9,32],{"type":6,"name":96,"description":97,"armGroupLabels":98,"otherNames":54},"Collect of data on non-reimbursed transport","Collect of data on non-reimbursed transport at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6",[38,9,32],{"type":6,"name":100,"description":101,"armGroupLabels":102,"otherNames":54},"Collect of everyday help","Collect of everyday help at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6",[38,9,32],{"type":6,"name":104,"description":105,"armGroupLabels":106,"otherNames":54},"Collection of the business resumption date","Collection of the business resumption date at Day 3,Day 7,Day14,Day 21 , day 42, Month 3, month 6",[38,9,32],{"type":6,"name":108,"description":109,"armGroupLabels":110,"otherNames":54},"SF36 questionnaire","SF36 questionnaire at inclusion, Day 3,Day 7,Day14,Day 21 , day 42, month 6",[38,9,32],{"type":6,"name":112,"description":113,"armGroupLabels":114,"otherNames":54},"Questionnaire EQ5D-5L","Questionnaire EQ5D-5L at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6",[38,9,32],{"type":6,"name":116,"description":117,"armGroupLabels":118,"otherNames":54},"FIGO Stadium","FIGO Stadium at inclusion and Day 42",[38,9,32],{"type":6,"name":120,"description":121,"armGroupLabels":122,"otherNames":54},"Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.)","Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.) at day 1, Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6",[38,9,32],{"type":6,"name":124,"description":125,"armGroupLabels":126,"otherNames":54},"Collection of adjuvant treatments","Collection of adjuvant treatments at month 6",[38,9,32],{"type":6,"name":128,"description":129,"armGroupLabels":130,"otherNames":54},"Recording of any complications, emergency room visits\u002Funscheduled consultations, additional work stoppages to the initial one","Recording of any complications, emergency room visits\u002Funscheduled consultations, additional work stoppages to the initial one at Day 3,Day 7,Day14,Day 21 , day 42, month 3, month 6",[38,9,32],{"type":6,"name":132,"description":133,"armGroupLabels":134,"otherNames":54},"Collection of data","Collection of data on age, baseline, BMI, histological type of cancer and surgical approach used",[43],[136],{"name":137,"role":138,"phone":139,"phoneExt":140,"email":141},"Vincent Lavoué","CONTACT","02 99 26 59.71","+33","Vincent.LAVOUE@chu-rennes.fr",[143,159,172,184,193,202,211,220,228,240,252,264,276,288,300],{"facility":144,"status":145,"city":146,"state":54,"zip":147,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":155,"contacts":156},"CHU de Lille, Hôpital Jeanne de Flandre","NOT_YET_RECRUITING","Lille","59000","France","FR",{"type":151,"coordinates":152},"Point",[153,154],3.05512,50.63391,{"lat":154,"lon":153},[157],{"name":158,"role":138,"phone":54,"phoneExt":54,"email":54},"Yohan Kerbage",{"facility":160,"status":161,"city":162,"state":54,"zip":163,"country":148,"countryCode":149,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"CHU LIMOGES, Hôpital Mère-Enfant","RECRUITING","Limoges","87042",{"type":151,"coordinates":165},[166,167],1.24759,45.83362,{"lat":167,"lon":166},[170],{"name":171,"role":138,"phone":54,"phoneExt":54,"email":54},"Tristan Gauthier",{"facility":173,"status":145,"city":174,"state":54,"zip":175,"country":148,"countryCode":149,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Hôpital Lariboisière\u002FHôpital Saint Louis","Paris","75010",{"type":151,"coordinates":177},[178,179],2.3488,48.85341,{"lat":179,"lon":178},[182],{"name":183,"role":138,"phone":54,"phoneExt":54,"email":54},"Cyrille Huchon",{"facility":185,"status":145,"city":174,"state":54,"zip":186,"country":148,"countryCode":149,"cosmosGeoPoint":187,"geoPoint":189,"contacts":190},"Hôpital Cochin","75014",{"type":151,"coordinates":188},[178,179],{"lat":179,"lon":178},[191],{"name":192,"role":138,"phone":54,"phoneExt":54,"email":54},"Bruno Borghese",{"facility":194,"status":161,"city":174,"state":54,"zip":195,"country":148,"countryCode":149,"cosmosGeoPoint":196,"geoPoint":198,"contacts":199},"Hôpital Européen Georges Pompidou","75015",{"type":151,"coordinates":197},[178,179],{"lat":179,"lon":178},[200],{"name":201,"role":138,"phone":54,"phoneExt":54,"email":54},"Henri Azaïs",{"facility":203,"status":145,"city":174,"state":54,"zip":204,"country":148,"countryCode":149,"cosmosGeoPoint":205,"geoPoint":207,"contacts":208},"Hôpital Bichat","75018",{"type":151,"coordinates":206},[178,179],{"lat":179,"lon":178},[209],{"name":210,"role":138,"phone":54,"phoneExt":54,"email":54},"Martin Koskas",{"facility":212,"status":145,"city":174,"state":54,"zip":213,"country":148,"countryCode":149,"cosmosGeoPoint":214,"geoPoint":216,"contacts":217},"Hôpital Tenon AP-HP","75020",{"type":151,"coordinates":215},[178,179],{"lat":179,"lon":178},[218],{"name":219,"role":138,"phone":54,"phoneExt":54,"email":54},"Yohann Dabi",{"facility":221,"status":145,"city":174,"state":54,"zip":54,"country":148,"countryCode":149,"cosmosGeoPoint":222,"geoPoint":224,"contacts":225},"Hôpital Pitié Salpêtrière",{"type":151,"coordinates":223},[178,179],{"lat":179,"lon":178},[226],{"name":227,"role":138,"phone":54,"phoneExt":54,"email":54},"Geoffroy Canlorbe",{"facility":229,"status":161,"city":230,"state":54,"zip":231,"country":148,"countryCode":149,"cosmosGeoPoint":232,"geoPoint":236,"contacts":237},"Hôpital Lyon Sud - Hospices Civils de Lyon","Pierre-Bénite","69495",{"type":151,"coordinates":233},[234,235],4.82424,45.70359,{"lat":235,"lon":234},[238],{"name":239,"role":138,"phone":54,"phoneExt":54,"email":54},"Pierre-Adrien Bolze",{"facility":241,"status":145,"city":242,"state":54,"zip":243,"country":148,"countryCode":149,"cosmosGeoPoint":244,"geoPoint":248,"contacts":249},"Hôpital privé des côtes d'Armor","Plérin","22190",{"type":151,"coordinates":245},[246,247],-2.76975,48.53451,{"lat":247,"lon":246},[250],{"name":251,"role":138,"phone":54,"phoneExt":54,"email":54},"Isabelle Jaffré",{"facility":253,"status":161,"city":254,"state":54,"zip":255,"country":148,"countryCode":149,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"CHU de Rennes","Rennes","35200",{"type":151,"coordinates":257},[258,259],-1.67431,48.11109,{"lat":259,"lon":258},[262],{"name":263,"role":138,"phone":54,"phoneExt":54,"email":54},"Vincent Lavoue",{"facility":265,"status":161,"city":266,"state":54,"zip":267,"country":148,"countryCode":149,"cosmosGeoPoint":268,"geoPoint":272,"contacts":273},"CHU de Rouen","Rouen","76031",{"type":151,"coordinates":269},[270,271],1.09932,49.44313,{"lat":271,"lon":270},[274],{"name":275,"role":138,"phone":54,"phoneExt":54,"email":54},"Morgane Perrin",{"facility":277,"status":145,"city":278,"state":54,"zip":279,"country":148,"countryCode":149,"cosmosGeoPoint":280,"geoPoint":284,"contacts":285},"CHU de Saint Etienne","Saint-Etienne","42055",{"type":151,"coordinates":281},[282,283],4.39,45.43389,{"lat":283,"lon":282},[286],{"name":287,"role":138,"phone":54,"phoneExt":54,"email":54},"Céline Chauleur",{"facility":289,"status":145,"city":290,"state":54,"zip":291,"country":148,"countryCode":149,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"CHU de Strasbourg - Hôpital de Hautepierre","Strasbourg","67200",{"type":151,"coordinates":293},[294,295],7.74553,48.58392,{"lat":295,"lon":294},[298],{"name":299,"role":138,"phone":54,"phoneExt":54,"email":54},"Cherif Akladios",{"facility":301,"status":145,"city":302,"state":54,"zip":303,"country":148,"countryCode":149,"cosmosGeoPoint":304,"geoPoint":308,"contacts":309},"CHU de Tours - Hôpital Bretonneau","Tours","37044",{"type":151,"coordinates":305},[306,307],0.70398,47.39484,{"lat":307,"lon":306},[310],{"name":311,"role":138,"phone":54,"phoneExt":54,"email":54},"Lobna OULDAMER",{"type":313,"investigatorFullName":54,"investigatorTitle":54,"investigatorAffiliation":54,"oldNameTitle":54,"oldOrganization":54},"SPONSOR","100542888","medico-economic-evaluation-of-robot-assisted-laparoscopy-compared-with-conventional-laparoscopy-in-hysterectomy-for-endometrial-cancer-100542888",false,"NCT06348719","Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer.","Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer: Multicentre Randomised Controlled Trial","ROBOT-ECO-GYN","Randomized Study:\n\nInclusion Criteria:\n\n* Patient with low-risk or intermediate-risk endometrial carcinoma (on pre-operative workup including histology on endometrial biopsy and pelvic and lumbo-aortic MRI) , i.e. patients with endometrioid-type endometrial adenocarcinoma cancer low-grade (grade 1 or 2) and pre-therapeutic FIGO stage I (FIGO classification 2023) on MRI.\n* Indication for minimally invasive STH (laparoscopy) given by the surgeon during the pre-op consultation.\n* Patient accepts the matching of pseudonymized data with the French National Health Data System (SNDS)\n* Major patient.\n* Patient having received information on the protocol and having signed a consent form, thus accepting randomization in the robot-assisted intervention group versus conventional laparoscopy.\n\nNon Inclusion Criteria:\n\n* Patient operated on by a surgeon with less than 30 cases of robotic surgery in the last year and\u002For with less than 50 cases of total robotic experience at the time of patient inclusion.\n* Patient refuses to participate in randomized controlled trial (refuses randomization)\n* The surgeon refuses the patient's participation in the randomized controlled trial (does not wish to randomize the patient).\n* The center does not have a robot\n* The center does not have a laparoscopic column with fluorescence\n* Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty;\n* Patient not affiliated to a French social security scheme\n* Patient participating in another interventional trial or in Jardé off-label research that impacts study data, or in RIPH3 that impacts study data\n* Pregnant or breast-feeding patient\n\nExclusion criteria :\n\n* Minimally invasive procedure contraindicated by pre-operative anesthesia.\n* Patient operated on by a robot other than one of the intuitive robot variants (Si, X and Xi).\n\nProspective cohort:\n\nInclusion Criteria:\n\n* Patient with low-risk or intermediate-risk endometrial carcinoma (on pre-operative workup including histology on endometrial biopsy and pelvic and lumbo-aortic MRI) , i.e. patient with endometrioid-type endometrial adenocarcinoma cancer low-grade (grade 1 or 2) and pre-therapeutic FIGO stage I (FIGO classification 2023) on MRI .\n* Indication for minimally invasive STH (laparoscopy) given by the surgeon during the pre-op consultation.\n* Patient accepts the matching of pseudonymized data with the French National Health Data System (SNDS)\n* Major patient.\n* Patient not included in randomized controlled trial because :\n\n  * Patient refuses to participate in randomized controlled trial (refusing randomization)\n  * The surgeon refuses the patient's participation in the randomized controlled trial (does not wish to randomize the patient)\n  * The center does not have a robot\n  * The center does not have a laparoscopic column with fluorescence\n  * The surgeon does not meet the required learning curve criteria (as a reminder: ≥ 30 cases of robotic surgery in the last year and with total robotic experience ≥ 50 procedures ) at the time of patient inclusion\n* Patient has been informed about the protocol and has signed a consent form.\n\nNon Inclusion Criteria:\n\n* Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty;\n* Patient not affiliated to a French social security scheme\n* Patient participating in another interventional trial or in Jardé off-label research that impacts study data, or in RIPH3 that impacts study data\n* Pregnant or breast-feeding patient\n\nExclusion criteria :\n\n* Minimally invasive procedure contraindicated by pre-operative anesthesia.\n* Patient operated on by a robot other than one of the intuitive robot variants (Si, X and Xi).\n\nRetrospective cohort:\n\nInclusion Criteria:\n\n* Patient with low-risk or intermediate-risk endometrial carcinoma (on pre-operative workup including histology on endometrial biopsy and pelvic and lumbo-aortic MRI) , i.e. patient with endometrioid-type endometrial adenocarcinoma cancer low-grade (grade 1 or 2) and pre-therapeutic FIGO stage I (FIGO classification 2023) on MRI).\n* STH performed during the inclusion period of the randomized controlled trial and\u002For the prospective cohortat a participating center, regardless of the approach used, not included in the randomized controlled trial and in the prospective cohort.\n* Patient not objecting to the collection and use of her data\n* Patient of legal age.\n\nNon Inclusion Criteria:\n\n* Person under legal protection (safeguard of justice, curatorship, guardianship) or person deprived of liberty;\n* Patient not affiliated to a French social security scheme\n\nSurgeons :\n\nInclusion Criteria:\n\n* Surgeon performing hysterectomy on patients included in the randomized study and\u002For prospective cohort\n* Surgeon not objecting to the collection and use of his data\n\nNon- inclusion Criteria:\n\nNone\n\nFirst surgical assistance in the field :\n\nInclusion Criteria:\n\n* First surgical assistance in the field performing hysterectomy on patients included in the randomized study and\u002For prospective cohort\n* First surgical assistance in the field not objecting to the collection and use of his data\n\nNon- inclusion Criteria:\n\nNone","FEMALE","18 Years",{"count":325,"type":326},1680,"ESTIMATED","INTERVENTIONAL",[329],"NA","The standard treatment for endometrial cancer is surgery, as long as the stage of the disease and the patient's condition allow. It consists of hysterectomy (TSH) with bilateral adnexectomy. The recommended surgical approach is the minimally invasive or laparoscopic route, whose oncological safety has been demonstrated by the LAP2 study.\n\nSince 2010 and the arrival of robotic surgery in gynaecology, the robot-assisted laparoscopic approach has gradually been used for endometrial cancer Hysterectomy.\n\nSeveral studies have suggested that the cost and effectiveness of laparoscopy may vary according to the age and body mass index of the patient.\n\nThe investigators therefore hypothesise that robot-assisted laparoscopy may be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France.\n\nThe investigators therefore hypothesise that robot-assisted laparoscopy could be more efficient than conventional laparoscopy for endometrial cancer hysterectomy in the context of an advanced learning curve in France. The investigators will also test the efficiency of the surgical technique as a function of age and Body mass Index.",[332],"Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma","2025-09-08",{"date":335,"type":336},"2025-09-15","ACTUAL",{"date":338,"type":336},"2024-09-23",{"date":340,"type":326},"2028-03",{"name":5,"class":6},15]