Effects of Intraoperative Warming Methods on Hematologic Inflammatory Indices in Laparoscopic Cholecystectomy (WARM-CHOL)

Ataturk University

Status: Not yet enrolling

Conditions: Laparoscopic Cholecystectomy; Inflammatory Response; Surgical Stress Response; Perioperative Hypothermia

Treatments: Device: Standard Active Warming Blanket; Device: External Warmer Group; Device: Intravenous Warmer Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07232251

B.30.2.ATA.0.01.00/657

2025/2

Details and patient eligibility

About

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.

Full description

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.

While 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.

This prospective, randomized, controlled, parallel-group study will be conducted at Atatürk University Faculty of Medicine, Department of Anesthesiology and Reanimation.

Eligible 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.

Participants will be randomly assigned to one of four groups:

Group C (Control): No active warming; standard passive insulation only.

Group FAW (Forced-Air Warming): Forced-air warming blanket applied from induction until the end of surgery.

Group FW (Fluid Warming): Intravenous fluids administered through a warming device.

Group CF (Combined Warming): Both forced-air warming and fluid warming used together.

Standardized 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.

Blood 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.

Primary Outcome:

Postoperative change in hematologic inflammatory indices [(neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic immune-inflammation index (SII)].

Secondary Outcomes:

Intraoperative temperature maintenance, recovery characteristics, and hypothermia-related adverse events.

Statistical 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.

This 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• Intraoperative hemodynamic instability requiring prolonged vasopressor support or blood transfusion.
• Missing or incomplete preoperative or postoperative CBC preventing calculation of inflammatory indices.
• Withdrawal of consent or loss to follow-up.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 4 patient groups

Control Group

Other 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)

Treatment:

Device: Standard Active Warming Blanket

Intravenous Warmer Group

Active Comparator 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.

Treatment:

Device: Intravenous Warmer Group

Device: Standard Active Warming Blanket

External Warmer Group

Active Comparator 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.

Treatment:

Device: External Warmer Group

Device: Standard Active Warming Blanket

Combined Warming Group (Intravenous + External)

Active Comparator group

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.

Treatment:

Device: Intravenous Warmer Group

Device: External Warmer Group

Device: Standard Active Warming Blanket