[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100580759":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":43,"interventions":56,"overallOfficials":33,"centralContacts":66,"locations":72,"responsibleParty":87,"collaborators":33,"id":90,"slug":33,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":33,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":33,"enrollmentInfo":98,"targetDuration":33,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":33,"overallStatus":75,"whyStopped":33,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Gangnam Severance Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Average operative time (in minutes).","The primary outcome is the average operative time (in minutes) from skin incision to skin closure. This measurement will compare surgical efficiency between the assistant-controlled laparoscopic instrumentation group and the full robotic instrumentation group.","At the end of the surgery",[14,18,21,25,29],{"measure":15,"description":16,"timeFrame":17},"Total cost of consumable surgical materials.","The total cost of surgical consumables, including robotic instruments, staplers, clips, and other disposable materials used during the procedure, will be calculated from the surgical expense records.","At the end of the surgery (up to 12 hours)",{"measure":19,"description":16,"timeFrame":20},"Quality of Recovery (QoR-15) scores at 72 hours postoperatively.","72 hours postoperatively",{"measure":22,"description":23,"timeFrame":24},"Time to first flatus and bowel movement.","The time taken for the patient to pass gas and have a bowel movement will be recorded to assess postoperative gastrointestinal recovery.","Up to 1 month after surgery",{"measure":26,"description":27,"timeFrame":28},"Postoperative laboratory markers (e.g., CRP, WBC).","Inflammatory markers, including C-reactive protein (CRP) and white blood cell (WBC) counts, will be measured from blood samples to evaluate the patient's inflammatory response.","Up to 5 days after surgery",{"measure":30,"description":31,"timeFrame":32},"Incidence of postoperative complications.","The incidence of postoperative complications, including infections, bleeding, anastomotic leakage, and other surgical site issues, will be recorded and classified according to the Clavien-Dindo classification.","Within 30 days postoperatively",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":33,"timePerspective":33,"maskingInfo":39},"RANDOMIZED","PARALLEL","Single Blind Randomized controlled","TREATMENT",{"masking":40,"maskingDescription":33,"whoMasked":41},"SINGLE",[42],"OUTCOMES_ASSESSOR",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"Assistant-Controlled Group","EXPERIMENTAL","The assistant performs vascular clipping using articulating Hemolock clip appliers or Challenger® clip appliers and performs the gastrointestinal anastomosis with an Echelon stapling system.",[49],"Procedure: Arm I (Assistant-Controlled Laparoscopic Instrumentation)",{"label":51,"type":52,"description":53,"interventionNames":54},"Full Robotic Group","ACTIVE_COMPARATOR","The surgeon performs vascular clipping using the robotic arm with Hemolock or Hemoclip appliers and performs anastomosis using a SureForm stapler.",[55],"Procedure: Arm II (Assistant-Controlled Laparoscopic Instrumentation)",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":33},"PROCEDURE","Arm I (Assistant-Controlled Laparoscopic Instrumentation)","In this group, robotic distal gastrectomy is performed with assistant-controlled laparoscopic instrumentation. The assistant conducts vascular clipping using articulating Hemolock clip appliers (Livsmed) or Challenger® clip appliers (B.Braun). For gastrointestinal anastomosis, the assistant operates an Echelon stapling system (Johnson \\& Johnson) via the assistant port. The surgeon controls the robotic console for all other surgical steps. This method utilizes a hybrid approach, combining robotic precision with laparoscopic efficiency.",[45],{"type":58,"name":63,"description":64,"armGroupLabels":65,"otherNames":33},"Arm II (Assistant-Controlled Laparoscopic Instrumentation)","In this group, all surgical steps, including vascular clipping and anastomosis, are performed using the robotic system. The surgeon utilizes the Da Vinci Xi system and switches robotic instruments as needed. Vascular clipping is performed with robotic Hemolock or Hemoclip appliers, and anastomosis is conducted using the SureForm robotic stapler. This fully robotic technique eliminates laparoscopic assistance and utilizes only robotic arms for the entire procedure.\n\nBoth groups follow the same postoperative care protocols, including standardized pain management and recovery assessments.",[51],[67],{"name":68,"role":69,"phone":70,"phoneExt":33,"email":71},"In Gyu Kwon","CONTACT","82-2-2019-4601","gsirb@yuhs.ac",[73],{"facility":74,"status":75,"city":76,"state":33,"zip":33,"country":77,"countryCode":33,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"GangnamSeveranceHospital","RECRUITING","Seoul","South Korea",{"type":79,"coordinates":80},"Point",[81,82],126.9784,37.566,{"lat":82,"lon":81},[85],{"name":86,"role":69,"phone":33,"phoneExt":33,"email":33},"InGyu Kwon",{"type":88,"investigatorFullName":68,"investigatorTitle":89,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Assistant Professor","100580759",false,"NCT06841484","Comparison of Full Robotic Instrumentation and Assistant-Controlled Laparoscopic Instrumentation in Robotic Distal Gastrectomy","Clinical Outcomes of Full Robotic Instrumentation Versus Assistant Controlled Laparoscopic Instrumentatin in Robotic Distal Gastrectomy: Randomized Pilot Study","Inclusion Criteria:\n\n1. Patients with histologically confirmed gastric adenocarcinoma prior to surgery.\n2. Patients who have undergone a complete (R0) resection.\n3. Patients with an ASA (American Society of Anesthesiologists) score of 3 or below.\n4. Patients undergoing robotic radical distal gastrectomy.\n\nExclusion Criteria:\n\n1. Patients under 19 years of age.\n2. Patients who have received preoperative chemotherapy or radiotherapy.\n3. Patients diagnosed with stage IV gastric cancer due to distant metastasis.\n4. Patients diagnosed with malignancies other than gastric cancer.\n5. Patients scheduled to undergo total gastrectomy.\n6. Patients requiring total omentectomy.","ALL","20 Years",{"count":99,"type":100},36,"ESTIMATED","INTERVENTIONAL",[103],"NA","This pilot study aims to provide valuable insights into the optimal surgical approach for robotic distal gastrectomy. By comparing full robotic procedures with assistant-controlled techniques, the results may guide future practice, enhancing surgical efficiency, reducing costs, and improving patient outcomes.",[106],"Gastric Cancer","2025-02-21",{"date":109,"type":110},"2025-02-24","ACTUAL",{"date":112,"type":110},"2025-02-01",{"date":114,"type":100},"2026-03-31",{"name":5,"class":6},1]