Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-25 @ 9:41 PM
Study NCT ID:
NCT07232251
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Intraoperative Warming Methods on Hematologic Inflammatory Indices in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'In this prospective, randomized, controlled trial, patients will be equally assigned to four groups:\n\nControl Group (standard blanket + passive blanket)\n\nIV Warmer Group (standard care + intravenous fluid warmer)\n\nExternal Warmer Group (standard care + external warmer)\n\nCombined Warmer Group (standard care + intravenous fluid warmer + external warmer)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-04-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-14', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Core Body Temperature', 'timeFrame': 'Intraoperative, measured continuously and recorded at the end of surgery (1 time point)', 'description': 'Core body temperature will be continuously monitored via esophageal probe throughout laparoscopic cholecystectomy. The primary outcome is the mean core temperature at the end of surgery, comparing the four intraoperative warming strategies (Control, IV warming, External warming, Combined IV + External warming).'}], 'secondaryOutcomes': [{'measure': 'Systemic Immune-Inflammation Index (SII)', 'timeFrame': 'Preoperative baseline, postoperative 1 hour, and postoperative 24 hours', 'description': 'SII will be calculated using neutrophil, lymphocyte, and platelet counts from complete blood counts to assess systemic inflammatory response.'}, {'measure': 'Neutrophil-to-Lymphocyte Ratio (NLR)', 'timeFrame': 'Preoperative baseline, postoperative 1 hour, and postoperative 24 hours', 'description': 'NLR will be calculated from complete blood counts to evaluate the balance between acute inflammation and immune function.'}, {'measure': 'Platelet-to-Lymphocyte Ratio (PLR)', 'timeFrame': 'Preoperative baseline, postoperative 1 hour, and postoperative 24 hours', 'description': 'PLR will be calculated from platelet and lymphocyte counts to assess postoperative inflammatory and thrombotic response.'}, {'measure': 'Lymphocyte-to-Monocyte Ratio (LMR)', 'timeFrame': 'Preoperative baseline, postoperative 1 hour, and postoperative 24 hours', 'description': 'LMR will be calculated from lymphocyte and monocyte counts to evaluate immune regulation and inflammatory balance after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['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'], 'conditions': ['Inflammatory Response', 'Perioperative Hypothermia', 'Laparoscopic Cholecystectomy', 'Surgical Stress Response']}, 'referencesModule': {'references': [{'pmid': '36681771', 'type': 'RESULT', 'citation': 'Wang J, Bi Y, Ma J, He Y, Liu B. Association of Preoperative Neutrophil-to-Lymphocyte Ratio with Postoperative Acute Kidney Injury and Mortality Following Major Noncardiac Surgeries. World J Surg. 2023 Apr;47(4):948-961. doi: 10.1007/s00268-022-06878-2. Epub 2023 Jan 21.'}, {'pmid': '36030214', 'type': 'RESULT', 'citation': 'Jiao Y, Zhang X, Liu M, Sun Y, Ma Z, Gu X, Gu W, Zhu W. Systemic immune-inflammation index within the first postoperative hour as a predictor of severe postoperative complications in upper abdominal surgery: a retrospective single-center study. BMC Gastroenterol. 2022 Aug 27;22(1):403. doi: 10.1186/s12876-022-02482-9.'}, {'pmid': '31289589', 'type': 'RESULT', 'citation': 'Gao Y, Guo W, Cai S, Zhang F, Shao F, Zhang G, Liu T, Tan F, Li N, Xue Q, Gao S, He J. Systemic immune-inflammation index (SII) is useful to predict survival outcomes in patients with surgically resected esophageal squamous cell carcinoma. J Cancer. 2019 Jun 2;10(14):3188-3196. doi: 10.7150/jca.30281. eCollection 2019.'}, {'pmid': '32799802', 'type': 'RESULT', 'citation': 'Xu H, Wang Z, Guan X, Lu Y, Malone DC, Salmon JW, Ma A, Tang W. Safety of intraoperative hypothermia for patients: meta-analyses of randomized controlled trials and observational studies. BMC Anesthesiol. 2020 Aug 15;20(1):202. doi: 10.1186/s12871-020-01065-z.'}, {'pmid': '40595941', 'type': 'RESULT', 'citation': 'Zheng W, Huang B, Bao L, Wang J, Jin J. Comparing warming strategies to reduce hypothermia and shivering in elderly abdominal or pelvic surgery patients: a network meta-analysis. Sci Rep. 2025 Jul 1;15(1):22356. doi: 10.1038/s41598-025-04644-7.'}, {'pmid': '39736577', 'type': 'RESULT', 'citation': 'Ji N, Wang J, Li X, Shang Y. Strategies for perioperative hypothermia management: advances in warming techniques and clinical implications: a narrative review. BMC Surg. 2024 Dec 30;24(1):425. doi: 10.1186/s12893-024-02729-0.'}, {'type': 'RESULT', 'citation': 'McSwain J. Perioperative hypothermia: Causes, consequences and treatment. World Journal of Anesthesiology. 11/27 2015;4:58. doi:10.5313/wja.v4.i3.58'}, {'pmid': '34444504', 'type': 'RESULT', 'citation': 'Rauch S, Miller C, Brauer A, Wallner B, Bock M, Paal P. Perioperative Hypothermia-A Narrative Review. Int J Environ Res Public Health. 2021 Aug 19;18(16):8749. doi: 10.3390/ijerph18168749.'}, {'pmid': '19137808', 'type': 'RESULT', 'citation': 'Reynolds L, Beckmann J, Kurz A. Perioperative complications of hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):645-57. doi: 10.1016/j.bpa.2008.07.005.'}, {'pmid': '30459033', 'type': 'RESULT', 'citation': 'Ruetzler K, Kurz A. Consequences of perioperative hypothermia. Handb Clin Neurol. 2018;157:687-697. doi: 10.1016/B978-0-444-64074-1.00041-0.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Unintended perioperative hypothermia (core temperature \\<36°C) commonly occurs during laparoscopic surgeries due to anesthesia-induced thermoregulatory impairment, pneumoperitoneum, and cold ambient conditions. Even mild decreases in body temperature can impair coagulation, delay drug metabolism, and alter immune function. Maintaining normothermia is therefore critical for improving surgical outcomes.\n\nWhile both forced-air warming systems and fluid warming devices are routinely used, limited data exist comparing their individual and combined effects on postoperative inflammatory responses. Hematologic inflammatory indices such as NLR, PLR, and SII provide cost-effective and reproducible markers that reflect systemic inflammation and immune balance.\n\nThis prospective, randomized, controlled, parallel-group study will be conducted at Atatürk University Faculty of Medicine, Department of Anesthesiology and Reanimation.\n\nEligible participants are adult patients (aged 18-65 years, ASA I-II) scheduled for elective laparoscopic cholecystectomy under general anesthesia. Patients with infection, chronic inflammatory disease, hematologic disorder, or those converted to open surgery will be excluded.\n\nParticipants will be randomly assigned to one of four groups:\n\nGroup C (Control): No active warming; standard passive insulation only.\n\nGroup FAW (Forced-Air Warming): Forced-air warming blanket applied from induction until the end of surgery.\n\nGroup FW (Fluid Warming): Intravenous fluids administered through a warming device.\n\nGroup CF (Combined Warming): Both forced-air warming and fluid warming used together.\n\nStandardized anesthesia induction and maintenance protocols will be followed for all patients. Core temperature will be continuously monitored via nasopharyngeal probe. Temperature, hemodynamic parameters, and perioperative variables will be recorded at fixed intervals.\n\nBlood samples will be obtained at two time points - preoperatively and at 24 hours postoperatively - for complete blood count analysis. The inflammatory indices (NLR, PLR, SII) will be calculated and compared among groups.\n\nPrimary Outcome:\n\nPostoperative change in hematologic inflammatory indices \\[(neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII)\\].\n\nSecondary Outcomes:\n\nIntraoperative temperature maintenance, recovery characteristics, and hypothermia-related adverse events.\n\nStatistical analyses will be performed using SPSS. Continuous variables will be expressed as mean ± SD or median (IQR) and analyzed using ANOVA or Kruskal-Wallis test, as appropriate. Categorical data will be compared using Chi-square or Fisher's exact test. A p-value \\<0.05 will be considered statistically significant.\n\nThis study seeks to clarify whether intraoperative thermal management strategies influence the systemic inflammatory response, potentially guiding clinicians toward the most effective warming method to enhance recovery and minimize postoperative complications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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 (\\<36.0 °C).\n* Operation duration \\<60 minutes or \\>180 minutes.\n* Endocrine/metabolic disorders affecting body temperature (e.g., moderate-severe thyroid dysfunction, pheochromocytoma, severe dysautonomia, malnutrition).\n* Active infection/sepsis or systemic infection within past 2 weeks.\n* Chronic immunosuppressive therapy (e.g., ≥10 mg/day 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 \\<100 ×10⁹/L, leukocyte \\<3 ×10⁹/L).\n* Active malignancy or ongoing chemotherapy/radiotherapy in last 3 months.\n* Severe organ failure (Child-Pugh C liver, eGFR \\<30 mL/min/1.73 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.'}, 'identificationModule': {'nctId': 'NCT07232251', 'acronym': 'WARM-CHOL', 'briefTitle': 'Effects of Intraoperative Warming Methods on Hematologic Inflammatory Indices in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'B.30.2.ATA.0.01.00/657'}, 'secondaryIdInfos': [{'id': '2025/2', 'type': 'OTHER', 'domain': 'Atatürk University Clinical Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control Group', 'description': '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)', 'interventionNames': ['Device: Standard Active Warming Blanket']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous Warmer Group', 'description': '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.', 'interventionNames': ['Device: Standard Active Warming Blanket', 'Device: Intravenous Warmer Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'External Warmer Group', 'description': '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.', 'interventionNames': ['Device: Standard Active Warming Blanket', 'Device: External Warmer Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combined Warming Group (Intravenous + External)', 'description': '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/thorax.', 'interventionNames': ['Device: Standard Active Warming Blanket', 'Device: Intravenous Warmer Group', 'Device: External Warmer Group']}], 'interventions': [{'name': 'Standard Active Warming Blanket', 'type': 'DEVICE', 'otherNames': ['MEDWARM W-300/A 150-MS/A 96116-K4656'], 'description': "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.", 'armGroupLabels': ['Combined Warming Group (Intravenous + External)', 'Control Group', 'External Warmer Group', 'Intravenous Warmer Group']}, {'name': 'Intravenous Warmer Group', 'type': 'DEVICE', 'otherNames': ['IV Fluid Warmer', 'Portable Flotherm QW3 Fluid And Blood Warmer'], 'description': '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.', 'armGroupLabels': ['Combined Warming Group (Intravenous + External)', 'Intravenous Warmer Group']}, {'name': 'External Warmer Group', 'type': 'DEVICE', 'otherNames': ['External Forced-Air Warming Device', '3M Bair Hugger 700 Series'], 'description': '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.', 'armGroupLabels': ['Combined Warming Group (Intravenous + External)', 'External Warmer Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Erzurum', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Erkan Cem Çelik, doctor', 'role': 'CONTACT', 'email': 'drerkancem@yahoo.com', 'phone': '+90-505-344-21-81'}, {'name': 'Mehmet Akif yılmaz, assistant doctor', 'role': 'CONTACT', 'email': 'mehmetakifyilmaz025@gmail.com', 'phone': '+90-534-653-35-39'}], 'facility': 'Ataturk University', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'centralContacts': [{'name': 'Erkan Cem Çelik, Doctor', 'role': 'CONTACT', 'email': 'drerkancem@yahoo.com', 'phone': '+90-505-344-21-81'}, {'name': 'Mehmet Akif Yılmaz, assistant doctor', 'role': 'CONTACT', 'email': 'mehmetakifyilmaz025@gmail.com', 'phone': '+90-534-653-35-39'}], 'overallOfficials': [{'name': 'Erkan Cem Çelik, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ataturk University Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data and supporting documents will be available starting 6 months after publication of the primary study results, for a period of 5 years.', 'ipdSharing': 'YES', 'description': 'De-identified participant data (demographics, perioperative temperature, hematologic inflammatory indices) will be made available upon reasonable request to qualified researchers after publication of the primary study results.', 'accessCriteria': 'Qualified researchers affiliated with recognized academic or clinical institutions may request access to the de-identified dataset and supporting documents via email to the corresponding author. Requests will be reviewed for scientific validity and compliance with ethical standards, and data will be shared under a data use agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Erkan Cem ÇELİK', 'investigatorAffiliation': 'Ataturk University'}}}}