[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610797":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":48,"centralContacts":53,"locations":64,"responsibleParty":79,"collaborators":58,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":58,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":105,"overallStatus":117,"whyStopped":58,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Ataturk University","OTHER",[8,13,19,24],{"label":9,"type":6,"description":10,"interventionNames":11},"Control Group","Patients receive standard intraoperative warming with 38 °C set active warming blanket. Surgical field outside the blanket is covered with passive drapes. No additional warming interventions are applied. (standart care)",[12],"Device: Standard Active Warming Blanket",{"label":14,"type":15,"description":16,"interventionNames":17},"Intravenous Warmer Group","ACTIVE_COMPARATOR","All standard procedures performed in the control group are followed. Additionally, all intravenous fluids administered during the operation are warmed to 38°C with a fluid warmer.",[12,18],"Device: Intravenous Warmer Group",{"label":20,"type":15,"description":21,"interventionNames":22},"External Warmer Group","All standard approaches used in the control group are performed. Additionally, a special drape is placed over the upper extremities and thorax, which is connected to a 3M Bair Hugger 700 Series device and warmed to 38°C.",[12,23],"Device: External Warmer Group",{"label":25,"type":15,"description":26,"interventionNames":27},"Combined Warming Group (Intravenous + External)","All standard approaches used in the control group are performed. Additionally, intravenous fluids are warmed and an external heating device is applied to the upper extremity\u002Fthorax.",[12,18,23],[29,36,42],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Standard Active Warming Blanket","An active blanket set at 38°C is used to maintain the patient's body temperature throughout the operation. Body areas outside the surgical field are covered with passive drapes. No supplemental heating is used.",[25,9,20,14],[35],"MEDWARM W-300\u002FA 150-MS\u002FA 96116-K4656",{"type":30,"name":14,"description":37,"armGroupLabels":38,"otherNames":39},"All intravenous fluids administered during the operation are administered via a fluid warming device at 38°C. All standard practices continue in the control group.",[25,14],[40,41],"IV Fluid Warmer","Portable Flotherm QW3 Fluid And Blood Warmer",{"type":30,"name":20,"description":43,"armGroupLabels":44,"otherNames":45},"A special drape is placed over the upper extremities and thorax, and the patient is connected to an external warm air device at 38°C throughout the operation. All standard practices continue in the control group.",[25,20],[46,47],"External Forced-Air Warming Device","3M Bair Hugger 700 Series",[49],{"name":50,"affiliation":51,"role":52},"Erkan Cem Çelik, doctor","Ataturk University Department of Anesthesiology and Reanimation","PRINCIPAL_INVESTIGATOR",[54,60],{"name":55,"role":56,"phone":57,"phoneExt":58,"email":59},"Erkan Cem Çelik, Doctor","CONTACT","+90-505-344-21-81",null,"drerkancem@yahoo.com",{"name":61,"role":56,"phone":62,"phoneExt":58,"email":63},"Mehmet Akif Yılmaz, assistant doctor","+90-534-653-35-39","mehmetakifyilmaz025@gmail.com",[65],{"facility":5,"status":58,"city":66,"state":58,"zip":67,"country":68,"countryCode":58,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Erzurum","25000","Turkey (Türkiye)",{"type":70,"coordinates":71},"Point",[72,73],41.27694,39.90861,{"lat":73,"lon":72},[76,77],{"name":50,"role":56,"phone":57,"phoneExt":58,"email":59},{"name":78,"role":56,"phone":62,"phoneExt":58,"email":63},"Mehmet Akif yılmaz, assistant doctor",{"type":52,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":58,"oldOrganization":58},"Erkan Cem ÇELİK","Principal Investigator","100610797","effects-of-intraoperative-warming-methods-on-hematologic-inflammatory-indices-in-laparoscopic-cholecystectomy-100610797",false,"NCT07232251","Effects of Intraoperative Warming Methods on Hematologic Inflammatory Indices in Laparoscopic Cholecystectomy","Evaluation of the Effects of Different Intraoperative Warming Techniques on Core Body Temperature and Hematologic Inflammatory Indices (SII, NLR, PLR, LMR) in Patients Undergoing Laparoscopic Cholecystectomy: A Prospective Randomized Controlled Study","WARM-CHOL","Inclusion Criteria:\n\n* Patients scheduled for elective laparoscopic cholecystectomy.\n* ASA (American Society of Anesthesiologists) physical status I-III.\n* Age between 18 and 65 years.\n* Willingness and ability to provide written informed consent.\n\nExclusion Criteria:\n\n* ASA IV-V patients.\n* Emergency surgery requirement.\n* Preoperative fever (\\>38.0 °C) or hypothermia (\\\u003C36.0 °C).\n* Operation duration \\\u003C60 minutes or \\>180 minutes.\n* Endocrine\u002Fmetabolic disorders affecting body temperature (e.g., moderate-severe thyroid dysfunction, pheochromocytoma, severe dysautonomia, malnutrition).\n* Active infection\u002Fsepsis or systemic infection within past 2 weeks.\n* Chronic immunosuppressive therapy (e.g., ≥10 mg\u002Fday prednisolone equivalent ≥2 weeks or biological agents in the past month).\n* Hematologic disorders (e.g., leukemia, aplastic anemia, myeloproliferative disorders) or abnormal blood counts (platelet \\\u003C100 ×10⁹\u002FL, leukocyte \\\u003C3 ×10⁹\u002FL).\n* Active malignancy or ongoing chemotherapy\u002Fradiotherapy in last 3 months.\n* Severe organ failure (Child-Pugh C liver, eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or dialysis, NYHA III-IV heart failure, GOLD III-IV COPD).\n* Coagulopathy or uncontrolled antithrombotic therapy.\n* Pregnancy or lactation.\n* Conversion from laparoscopic to open surgery.\n* Non-adherence to assigned warming protocol.\n* Inability to place esophageal temperature probe or unreliable temperature monitoring.\n* Intraoperative hemodynamic instability requiring prolonged vasopressor support or blood transfusion.\n* Missing or incomplete preoperative or postoperative CBC preventing calculation of inflammatory indices.\n* Withdrawal of consent or loss to follow-up.","ALL","18 Years","65 Years",{"count":94,"type":95},128,"ESTIMATED","INTERVENTIONAL",[98],"NA","Perioperative hypothermia is a frequent and preventable complication that may cause adverse outcomes such as increased blood loss, impaired coagulation, and delayed recovery. Various active warming techniques are used to maintain normothermia during anesthesia; however, their comparative effects on systemic inflammatory responses remain unclear.\n\nThis randomized controlled clinical trial aims to evaluate the effects of different intraoperative warming methods on hematologic inflammatory indices - including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII) - in patients undergoing elective laparoscopic cholecystectomy under general anesthesia.\n\nA total of eligible adult patients will be randomly assigned into four groups according to the intraoperative warming method applied:\n\nControl Group: No active warming applied.\n\nForced-Air Warming (FAW) Group: Warming blanket system used throughout surgery.\n\nFluid Warming (FW) Group: Intravenous fluids warmed to maintain normothermia.\n\nCombined Warming (FAW + FW) Group: Both forced-air and fluid warming applied simultaneously.\n\nCore body temperature and perioperative data will be recorded. Venous blood samples will be obtained preoperatively and 24 hours postoperatively to calculate inflammatory indices.\n\nThe primary objective is to determine whether active intraoperative warming techniques modulate postoperative inflammatory markers compared to no warming. Secondary outcomes include intraoperative temperature trends, recovery times, and the incidence of hypothermia-related complications.\n\nThe results are expected to identify the most effective warming strategy to minimize inflammation and optimize postoperative recovery in laparoscopic procedures.",[101,102,103,104],"Inflammatory Response","Perioperative Hypothermia","Laparoscopic Cholecystectomy","Surgical Stress Response",[106,107,108,109,110,111,112,113,114,115,116],"Intraoperative warming","Forced-air warming","Combined warming","Hypothermia prevention","Fluid warming","Hematologic inflammatory indices","Neutrophil-to-lymphocyte ratio (NLR)","Platelet-to-lymphocyte ratio (PLR)","Systemic immune-inflammation index (SII)","Laparoscopic surgery","Cholecystectomy","NOT_YET_RECRUITING","2025-11-17",{"date":120,"type":121},"2025-11-19","ACTUAL",{"date":123,"type":95},"2025-12-01",{"date":125,"type":95},"2026-04-02",{"name":5,"class":6},1]