protocolSection identificationModule nctId: NCT06348719, orgStudyIdInfo id: 35RC21_9732_ROBOT-ECO-GYN, briefTitle: Medico-economic Evaluation of Robot-assisted Laparoscopy Compared With Conventional Laparoscopy in Hysterectomy for Endometrial Cancer., acronym: ROBOT-ECO-GYN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2027-10, completionDateStruct date: 2027-10, studyFirstPostDateStruct date: 2024-04-05, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Rennes University Hospital, class: OTHER, descriptionModule briefSummary: 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.Since 2010 and the arrival of robotic surgery in gynaecology, the robot-assisted laparoscopic approach has gradually been used for endometrial cancer Hysterectomy.Several studies have suggested that the cost and effectiveness of laparoscopy may vary according to the age and body mass index of the patient.The 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.The 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., conditionsModule conditions: Hysterectomies for Low- or Intermediate-risk Endometrial Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: As part of this project, we are proposing an original approach by combining a randomized controlled trial with a prospective observational cohort and a retrospective cohort.This research will therefore consist of 3 complementary studies :A multicenter, parallel-group, open-label, randomized controlled superiority trial (ratio 1:1) comparing two groups:* Group 1: laparoscopic robot-assisted hysterectomy* Group 2: conventional laparoscopic hysterectomy A prospective cohort based on the randomized controlled trial A retrospective cohort, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 1680, type: ESTIMATED, armsInterventionsModule interventions name: Robot-assisted laparoscopy, interventions name: conventional laparoscopy, interventions name: Prospective cohort study, interventions name: Retrospective cohort study, interventions name: information and consent, interventions name: randomization, interventions name: Collection of socio-demographic, clinical, biological, imaging and histopathological data, treatment decision, recurrence, interventions name: Surgical data collection, interventions name: Biological data collection, interventions name: Collection of histological data from the surgical specimen, interventions name: Phone calls, interventions name: Pain assessment, interventions name: Collect of data on non-reimbursed transport, interventions name: Collect of everyday help, interventions name: Collection of the business resumption date, interventions name: SF36 questionnaire, interventions name: Questionnaire EQ5D-5L, interventions name: FIGO Stadium, interventions name: Collection of treatments (analgesics and anticoagulants up to J42, complication-related treatments, etc.), interventions name: Collection of adjuvant treatments, interventions name: Recording of any complications, emergency room visits/unscheduled consultations, additional work stoppages to the initial one, interventions name: Collection of data, outcomesModule primaryOutcomes measure: Cost-utility ratio expressed in terms of costs / QALY, secondaryOutcomes measure: Operating time, secondaryOutcomes measure: Conversion rate, secondaryOutcomes measure: Rate and nature of intraoperative complications, secondaryOutcomes measure: Post-operative complication rate and nature at D42 (Clavien-Dindo classification), secondaryOutcomes measure: Post-operative complication rate and nature at M6 (Clavien-Dindo classification), secondaryOutcomes measure: Volume of intraoperative blood loss, secondaryOutcomes measure: Number of RBC, FFP, PC transfused during hospital stay, secondaryOutcomes measure: Visual analogue scale (VAS) of pain 6h after surgery, secondaryOutcomes measure: Visual analogue scale (VAS) of pain 24h after surgery, secondaryOutcomes measure: Visual analogue scale (VAS) of pain D3 after surgery, secondaryOutcomes measure: Analgesic consumption at D1 after surgery, secondaryOutcomes measure: Analgesic consumption at D3 after surgery, secondaryOutcomes measure: Analgesic consumption at D7 after surgery, secondaryOutcomes measure: Analgesic consumption at D42 after surgery, secondaryOutcomes measure: EQ-5D-5L at inclusion after surgery, secondaryOutcomes measure: EQ-5D-5L at D1 after surgery, secondaryOutcomes measure: EQ-5D-5L at D3 after surgery, secondaryOutcomes measure: EQ-5D-5L at D7 after surgery, secondaryOutcomes measure: EQ-5D-5L at D14 after surgery, secondaryOutcomes measure: EQ-5D-5L at D21 after surgery, secondaryOutcomes measure: EQ-5D-5L at D42 after surgery, secondaryOutcomes measure: EQ-5D-5L at M3 after surgery, secondaryOutcomes measure: EQ-5D-5L at M6 after surgery, secondaryOutcomes measure: SF-36 at baseline after surgery, secondaryOutcomes measure: SF-36 at D3 after surgery, secondaryOutcomes measure: SF-36 at D7 after surgery, secondaryOutcomes measure: SF-36 at D42 after surgery, secondaryOutcomes measure: SF-36 at M6 after surgery, secondaryOutcomes measure: Consumption of care: average length of hospital stay, secondaryOutcomes measure: Consumption of care: average of number of re-hospitalizations,, secondaryOutcomes measure: Consumption of care: average of emergency room visits, secondaryOutcomes measure: Consumption of care: average of number of gynecologist consultations, secondaryOutcomes measure: Consumption of care: quantity of analgesic(s), secondaryOutcomes measure: Consumption of care:, secondaryOutcomes measure: Consumption of care: average of number of work stoppage(s)., secondaryOutcomes measure: Time to initiate adjuvant treatment when indicated, secondaryOutcomes measure: Vital status at 6 months, secondaryOutcomes measure: Gas recovery time, secondaryOutcomes measure: QALYs from a collective perspective at D42, secondaryOutcomes measure: QALYs from a collective perspective at M6., secondaryOutcomes measure: Number of patients who underwent each approach, secondaryOutcomes measure: QALYs and average costs in relation to care consumption of patients included in the prospective cohort and in the randomized controlled trial according to the approach used and subgroups defined by age (<or> to 75 years) and BMI <or> to 30 kg/m2)., secondaryOutcomes measure: Surgical teams' perception of the benefits and limitations of robotic surgery in this indication, as well as perceived barriers and levers to the deployment of robot-assisted surgery in low- or intermediate-risk endometrial cancer., secondaryOutcomes measure: Assessment of the surgeon's physical stress during and at the end of the operation using the Borg scale, secondaryOutcomes measure: Assessment of the surgeon's physical stress during and at the end of the operation using the NASA-TLX, secondaryOutcomes measure: Total annual costs of the foreseeable spread of robot-assisted surgery, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: CHU de Lille, Hôpital Jeanne de Flandre, city: Lille, zip: 59000, country: France, contacts name: Yohan Kerbage, role: CONTACT, geoPoint lat: 50.63297, lon: 3.05858, locations facility: CHU LIMOGES, Hôpital Mère-Enfant, city: Limoges, zip: 87042, country: France, geoPoint lat: 45.83153, lon: 1.25781, locations facility: Hôpital Lariboisière/Hôpital Saint Louis, city: Paris, zip: 75010, country: France, contacts name: Cyrille Huchon, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Cochin, city: Paris, zip: 75014, country: France, contacts name: Bruno Borghese, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Européen Georges Pompidou, city: Paris, zip: 75015, country: France, contacts name: Henri Azaïs, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Bichat, city: Paris, zip: 75018, country: France, contacts name: Martin Koskas, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Tenon AP-HP, city: Paris, zip: 75020, country: France, contacts name: Yohann Dabi, role: CONTACT, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Pitié Salpêtrière, city: Paris, country: France, geoPoint lat: 48.85341, lon: 2.3488, locations facility: Hôpital Lyon Sud - Hospices Civils de Lyon, city: Pierre-Bénite, zip: 69495, country: France, contacts name: Pierre-Adrien Bolze, role: CONTACT, geoPoint lat: 45.7009, lon: 4.82511, locations facility: Hôpital privé des côtes d'Armor, city: Plerin, zip: 22190, country: France, contacts name: Isabelle Jaffré, role: CONTACT, geoPoint lat: 48.54249, lon: -2.77983, locations facility: CHU de Rennes, Hôpital Sud, city: Rennes, zip: 35200, country: France, contacts name: Vincent Lavoue, role: CONTACT, geoPoint lat: 48.11198, lon: -1.67429, locations facility: CHU de Rouen, city: Rouen, zip: 76031, country: France, contacts name: Morgane Perrin, role: CONTACT, geoPoint lat: 49.44313, lon: 1.09932, locations facility: CHU de Saint Etienne, city: Saint Etienne, zip: 42055, country: France, contacts name: Céline Chauleur, role: CONTACT, geoPoint lat: 45.43389, lon: 4.39, locations facility: CHU de Strasbourg - Hôpital de Hautepierre, city: Strasbourg, zip: 67200, country: France, geoPoint lat: 48.58392, lon: 7.74553, locations facility: CHU de Tours - Hôpital Bretonneau, city: Tours, zip: 37044, country: France, contacts name: Lobna OULDAMER, role: CONTACT, geoPoint lat: 47.38333, lon: 0.68333, hasResults: False