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Keeping warm during surgery may reduce inflammation, study hopes

NCT ID NCT07232251

Knowledge-focused Sponsor: Ataturk University Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests different ways to keep patients warm during laparoscopic gallbladder removal. 128 adults will be randomly assigned to receive no active warming, a warming blanket, warmed IV fluids, or both. Researchers will measure body temperature and blood markers of inflammation before and after surgery to see which method works best.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Forced-air warming blanket and intravenous fluid warmer
What this could lead to
If successful, this could identify the best way to keep patients warm during gallbladder surgery, potentially reducing inflammation and speeding recovery.
What could go wrong
This is a small, early-stage study focused on lab markers, not patient outcomes. The results may not apply to other surgeries or lead to clear clinical benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 128 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Apr 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

inflammatory disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Inflammatory response Laparoscopic cholecystectomy Perioperative hypothermia Surgical stress response

How to take part

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  1. The places running it

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  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Ataturk University

    Erzurum, 25000, Turkey (Türkiye)

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