Clinical Trial

Effects of Intraoperative Warming Methods on Hematologic Inflammatory Indices in Laparoscopic Cholecystectomy

Study acronym: WARM-CHOL
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Record status
This record was last updated November 19, 2025 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-11-14.
Trial Details
NCT Number NCT07232251
Lead Sponsor Ataturk University
Conditions Inflammatory Response, Perioperative Hypothermia, Laparoscopic Cholecystectomy, Surgical Stress Response
Enrollment 128 participants
Start Date 2025-12-01
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-04-02 (estimated)
Updated on ClinicalTrials.gov 2025-11-19