[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hysterectomies-for-low--or-intermediate-risk-endometrial-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hysterectomies-for-low--or-intermediate-risk-endometrial-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},1680,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma","RECRUITING","2025-09-08",{"date":31,"type":32},"2025-09-15","ACTUAL",{"date":34,"type":32},"2024-09-23",{"date":36,"type":21},"2028-03",{"name":38,"class":39},"Rennes University Hospital","OTHER",15]