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

Study acronym: WARM-CHOL
StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Trial completed
    • Primary completion date changed from estimate of Oct 15, 2026 to Oct 7, 2026
    • Study completion date changed from estimate of Oct 17, 2026 to Oct 8, 2026
    • Site details revised
  2. Primary completion pushed from Apr 1, 2026 to Oct 15, 2026 Show 6 more changesShow less
    • Recruitment opened
    • Study completion pushed from Apr 2, 2026 to Oct 17, 2026
    • Eligibility criteria expanded, about 14 words
    • Study description revised
    • Site details revised
    • Publications: details revised at 10 of 10 entries
  3. Study description expanded, about 8 words
    • Study title shortened, about 4 words
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT07232251
Lead Sponsor Ataturk University
Conditions
(from sponsor)		 Inflammatory Response, Perioperative Hypothermia, Laparoscopic Cholecystectomy, Surgical Stress Response
Enrollment 128 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov