protocolSection identificationModule nctId: NCT06362070, orgStudyIdInfo id: COMPAR-G, briefTitle: Comparison of Outcomes of Multiple Platforms for Assisted Robotic - Gastrectomy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-03-30, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-04-12, lastUpdatePostDateStruct date: 2024-04-12, sponsorCollaboratorsModule leadSponsor name: Azienda Ospedaliera Universitaria Integrata Verona, class: OTHER, descriptionModule briefSummary: The object of this exploratory clinical trial is to evaluate intra and post-operative complications in a population that underwent Robotic Gastrectomy, with multiple platforms:* DaVinci;* Hugo;* Versius.This study is divided into two phases: in the first phase, gastrectomy will be performed using both the new platforms (Hugo and Versius) and the standard platform (Da Vinci), to evaluate the feasibility of the surgical procedure. In the second phase, the three platforms will be compared to evaluate any differences in the learning curve for an upper-GI surgeon, expert in laparoscopic surgery but not with robotic one.The questions it aims to answer are:* Are differences (intra-operative, post-operative, oncological, functional, technical, and economic) among the three different platforms observable?* Are there any differences between the three platforms related to the learning curve for surgeons?Participants will be enrolled, after obtaining informed consent, in one of the following cohorts:1. surgery with the daVinci platform;2. surgery with the Hugo platform;3. surgery with the Versius platform., conditionsModule conditions: Gastric Cancer, conditions: Gastrointestinal Cancer, conditions: Neoplasms, conditions: Gastric Diffuse Adenocarcinoma, conditions: Gastric Neoplasm, conditions: Stomach Adenocarcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 75, type: ESTIMATED, armsInterventionsModule interventions name: DaVinci® Surgical System, interventions name: Hugo™ RAS System, interventions name: Versius® Robotic Surgery System, outcomesModule primaryOutcomes measure: Conversion rate to open or laparoscopic approach (Phase 1), primaryOutcomes measure: Number of participants with major intraoperative complications (Phase 1), primaryOutcomes measure: Evaluation of surgical times of the standardized procedures (Phase 2), primaryOutcomes measure: Analysis of video of surgical procedures (Phase 2), secondaryOutcomes measure: Estimated Blood Loss, secondaryOutcomes measure: Overall duration of the surgery, secondaryOutcomes measure: Anesthesia, Lymphadenectomy, Gastrectomy (10 different surgical steps), secondaryOutcomes measure: Number of participants with major postoperative complications, secondaryOutcomes measure: Compliance rate to ERAS protocol, secondaryOutcomes measure: Postoperative hospitalization, secondaryOutcomes measure: Postoperative pain, secondaryOutcomes measure: Re-admission rate to hospitalization, secondaryOutcomes measure: Damage due to positioning, secondaryOutcomes measure: Positive Surgical Margin, secondaryOutcomes measure: Lymph nodes resection, secondaryOutcomes measure: Quality of Life Evaluation, secondaryOutcomes measure: Time taken for platform-related technical steps, secondaryOutcomes measure: Possible malfunction of the platform, secondaryOutcomes measure: Non-Technical Skills Assessment (NTS) demonstrated by members of the surgical team during the intraoperative phase., secondaryOutcomes measure: Procedure-related costs, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: General and Upper GI Unit, status: RECRUITING, city: Verona, zip: 37126, country: Italy, contacts name: Simone SG Giacopuzzi, MD, Prof, role: CONTACT, phone: +39 0458127510, email: simone.giacopuzzi@univr.it, contacts name: Simone Giacopuzzi, MD, Prof, role: PRINCIPAL_INVESTIGATOR, contacts name: Maria Bencivenga, MD, Prof, role: SUB_INVESTIGATOR, geoPoint lat: 45.4299, lon: 10.98444, hasResults: False