Effects of Intraoperative Warming Methods on Hematologic Inflammatory Indices in Laparoscopic Cholecystectomy
WARM-CHOL
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
2 other identifiers
interventional
128
1 country
1
Brief Summary
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. This 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. A total of eligible adult patients will be randomly assigned into four groups according to the intraoperative warming method applied: Control Group: No active warming applied. Forced-Air Warming (FAW) Group: Warming blanket system used throughout surgery. Fluid Warming (FW) Group: Intravenous fluids warmed to maintain normothermia. Combined Warming (FAW + FW) Group: Both forced-air and fluid warming applied simultaneously. Core body temperature and perioperative data will be recorded. Venous blood samples will be obtained preoperatively and 24 hours postoperatively to calculate inflammatory indices. The 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. The results are expected to identify the most effective warming strategy to minimize inflammation and optimize postoperative recovery in laparoscopic procedures.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 18, 2025
CompletedStudy Start
First participant enrolled
December 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2026
CompletedNovember 19, 2025
November 1, 2025
4 months
November 14, 2025
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative Core Body Temperature
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).
Intraoperative, measured continuously and recorded at the end of surgery (1 time point)
Secondary Outcomes (4)
Systemic Immune-Inflammation Index (SII)
Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Neutrophil-to-Lymphocyte Ratio (NLR)
Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Platelet-to-Lymphocyte Ratio (PLR)
Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Lymphocyte-to-Monocyte Ratio (LMR)
Preoperative baseline, postoperative 1 hour, and postoperative 24 hours
Study Arms (4)
Control Group
OTHERPatients 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)
Intravenous Warmer Group
ACTIVE COMPARATORAll 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.
External Warmer Group
ACTIVE COMPARATORAll 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.
Combined Warming Group (Intravenous + External)
ACTIVE COMPARATORAll 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Patients scheduled for elective laparoscopic cholecystectomy.
- ASA (American Society of Anesthesiologists) physical status I-III.
- Age between 18 and 65 years.
- Willingness and ability to provide written informed consent.
You may not qualify if:
- ASA IV-V patients.
- Emergency surgery requirement.
- Preoperative fever (\>38.0 °C) or hypothermia (\<36.0 °C).
- Operation duration \<60 minutes or \>180 minutes.
- Endocrine/metabolic disorders affecting body temperature (e.g., moderate-severe thyroid dysfunction, pheochromocytoma, severe dysautonomia, malnutrition).
- Active infection/sepsis or systemic infection within past 2 weeks.
- Chronic immunosuppressive therapy (e.g., ≥10 mg/day prednisolone equivalent ≥2 weeks or biological agents in the past month).
- Hematologic disorders (e.g., leukemia, aplastic anemia, myeloproliferative disorders) or abnormal blood counts (platelet \<100 ×10⁹/L, leukocyte \<3 ×10⁹/L).
- Active malignancy or ongoing chemotherapy/radiotherapy in last 3 months.
- 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).
- Coagulopathy or uncontrolled antithrombotic therapy.
- Pregnancy or lactation.
- Conversion from laparoscopic to open surgery.
- Non-adherence to assigned warming protocol.
- Inability to place esophageal temperature probe or unreliable temperature monitoring.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ataturk University
Erzurum, 25000, Turkey (Türkiye)
Related Publications (10)
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: 36681771RESULTJiao 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: 36030214RESULTGao 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: 31289589RESULTXu 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: 32799802RESULTZheng 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: 40595941RESULTJi 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.
PMID: 39736577RESULTMcSwain J. Perioperative hypothermia: Causes, consequences and treatment. World Journal of Anesthesiology. 11/27 2015;4:58. doi:10.5313/wja.v4.i3.58
RESULTRauch 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: 34444504RESULTReynolds 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: 19137808RESULTRuetzler K, Kurz A. Consequences of perioperative hypothermia. Handb Clin Neurol. 2018;157:687-697. doi: 10.1016/B978-0-444-64074-1.00041-0.
PMID: 30459033RESULT
Study Officials
- PRINCIPAL INVESTIGATOR
Erkan Cem Çelik, doctor
Ataturk University Department of Anesthesiology and Reanimation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 18, 2025
Study Start
December 1, 2025
Primary Completion
April 1, 2026
Study Completion
April 2, 2026
Last Updated
November 19, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Data and supporting documents will be available starting 6 months after publication of the primary study results, for a period of 5 years.
- Access Criteria
- 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.
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.