Impact of low body temperature on infection risk after gallbladder surgery
Uncontrolled Inadvertent Perioperative Hypothermia as a Risk Factor for Surgical Site Infection in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
This study is trying to see if having a low body temperature during gallbladder surgery increases the risk of infections after the operation for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Cumhuriyet University Academic / other |
| Locations | 2 sites (Sivas, Suşehri and 1 other locations) |
| Trial ID | NCT06035627 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between inadvertent perioperative hypothermia (IPH) and surgical site infections (SSI) in patients undergoing laparoscopic cholecystectomy. It will involve monitoring body temperatures and biomarkers of 100 patients, divided into a case group and a control group, to assess the potential impact of IPH on SSI. The study will take place in the general surgery clinic and operating room of a university hospital, with a focus on collecting data preoperatively, intraoperatively, and postoperatively.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who are scheduled for laparoscopic cholecystectomy and have an ASA score of I-II.
Not a fit: Patients who are under 18 or over 65, have an ASA score above III, or require emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights that lead to improved prevention strategies for surgical site infections in laparoscopic surgeries.
How similar studies have performed: While there are conflicting results in existing literature regarding the relationship between IPH and SSI, this study aims to clarify this relationship specifically in laparoscopic surgery, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Being aged 18-65 years old, * Having an ASA score of I-II, * Remaining in the hospital for at least 24 hours in the postoperative period, * Undergoing laparoscopic cholecystectomy Exclusion Criteria: * Being under 18 or over 65, * Having an ASA score above III, * Requiring emergency surgery * Having a neurological, psychiatric, or neuromuscular disease, * Being addicted to alcohol and/or other toxic substances, * Being pregnant or having a suspected pregnancy, * Undergoing open surgery, or being converted to an open procedure during surgery, * Having symptoms of fever * Having an active infection excluding cholecystitis.
Where this trial is running
Sivas, Suşehri and 1 other locations
- Cumhuriyet University — Sivas, Suşehri, Turkey (Recruiting)
- Sivas Cumhuriyet University — Sivas, Turkey (Recruiting)
Study contacts
- Principal investigator: Pınar YILMAZ EKER, Ph.D — corresponding researcher
- Study coordinator: Pınar YILMAZ EKER, Ph.D.
- Email: yilmazpinar20@gmail.com
- Phone: +905309468919
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.