The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.

Recruiting

• Conditions: Surgical Site Infection; Perioperative Complication
• Interventions: Other: Prevention hypothermia

• Registration Number: NCT06035627
• Lead Sponsor: Cumhuriyet University

Brief Summary

There are conflicting results in the literature explaining the relationship between surgical site infection (SSI) and inadvertent perioperative hypothermia (IPH). Although it is thought that the risk of IPH is lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts as to whether there is a relationship between IPH and SSI in laparoscopic surgery patients. A randomized controlled study will be planned in the future to examine the effect of IPH on SSI in patients who will undergo laparoscopic cholecystectomies. The study will be conducted in the general surgery clinic and operating room of a university hospital. It will be completed with a total of 100 patients, 50 of whom will be in the case group, and 50 will be in the control group.

Detailed Description

Objective: This study was conducted to examine the effect of inadvertent perioperative hypothermia (IPH) on Surgical Site Infection (SSI) in patients undergoing laparoscopic cholecystectomy.

Summary of Background Data: There are conflicting results in the literature explaining the relationship between SSI and IPH. Although the risk of IPH is thought to be lower in laparoscopic surgery types due to the short duration of the surgical procedure, these conflicting results raise doubts about the existence of a relationship between IPH and SSI in laparoscopic surgery patients.

Methods: This study will be a quasi-experimental and randomized controlled study in the future. The study will be conducted with patients who will have undergone laparoscopic cholecystectomy in the general surgery clinic and operating room of a university hospital. The study will be completed with a total of 100 patients, 50 in the case group, and 50 in the control group. During the study, preoperative, intraoperative, and postoperative body temperatures, as well as biomarkers of the patients, will be monitored using a form developed by the researchers. Additionally, patients will be followed up postoperatively to evaluate the potential impact of IPH on SSI.

Study Timeline

• Study Start: 2023-05-15
• Study First Submitted: 2023-08-28
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-11
• Last Update Submitted: 2023-09-11
• Study First Posted: 2023-09-13
• Last Update Posted: 2023-09-13
• Primary Completion: 2024-05-15
• Study Completion: 2024-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experimental group	Prevention hypothermia	The population of the study consisted of patients who were being treated in the general surgery clinic of the hospital, who met the sampling criteria, who were to undergo laparoscopic cholecystectomy, and who agreed to participate in the study. The sample size of the study was determined by the G\*Power 3.1.9.7 program. In the power analysis, when α =0.05, β=0.10, and 1-β =0.90, the sample size was determined as 50 people per group and a total of 100 people.

Primary Outcome Measures

Name	Time	Method
Prevention of inadvertent perioperative hypothermia	September 15, 2022- September 15, 2023	This study aims to evaluate whether inadvertent perioperative hypothermia has an effect on surgical site infection. For this, applications to prevent hypothermia will be applied to the patients in the experimental group

Secondary Outcome Measures

Name	Time	Method
Following surgical site infection	16 September 16, 2023 - October 25, 2023	After the applications for preventing hypothermia in the experimental group and the patients in the experimental and control groups will be examined for surgical site infection.

Trial Locations

Locations (2)

Sivas Cumhuriyet University; 🇹🇷 Sivas, Turkey

Cumhuriyet University; 🇹🇷 Sivas, Suşehri, Turkey