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

Surgical Site Infection Clinical Trial

Official title:

Uncontrolled Inadvertent Perioperative Hypothermia as a Risk Factor for Surgical Site Infection in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06035627
• Other study ID #: PYILMAZEKER
• Status: Recruiting
• Start date: May 15, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: September 2023
• Source: Cumhuriyet University
• Contact: Pinar YILMAZ EKER, Ph.D.
• Phone: +905309468919
• Email: yilmazpinar20[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 15, 2024
• Est. primary completion date: May 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Hypothermia
• Infections
• Perioperative Complication
• Surgical Site Infection
• Surgical Wound Infection

Intervention

Other:
• Prevention hypothermia
Hypothermia was prevented by warming the case group. control group remained stable. As a result, the presence of surgical site infection was followed.

Locations

Country	Name	City	State
Turkey	Cumhuriyet University	Sivas	Susehri
Turkey	Sivas Cumhuriyet University	Sivas

Sponsors (1)

Lead Sponsor	Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Chen HY, Su LJ, Wu HZ, Zou H, Yang R, Zhu YX. Risk factors for inadvertent intraoperative hypothermia in patients undergoing laparoscopic surgery: A prospective cohort study. PLoS One. 2021 Sep 23;16(9):e0257816. doi: 10.1371/journal.pone.0257816. eCollection 2021. — View Citation

Connelly L, Cramer E, DeMott Q, Piperno J, Coyne B, Winfield C, Swanberg M. The Optimal Time and Method for Surgical Prewarming: A Comprehensive Review of the Literature. J Perianesth Nurs. 2017 Jun;32(3):199-209. doi: 10.1016/j.jopan.2015.11.010. Epub 2016 Sep 1. — View Citation

Horn EP, Bein B, Broch O, Iden T, Bohm R, Latz SK, Hocker J. Warming before and after epidural block before general anaesthesia for major abdominal surgery prevents perioperative hypothermia: A randomised controlled trial. Eur J Anaesthesiol. 2016 May;33(5):334-40. doi: 10.1097/EJA.0000000000000369. — View Citation

Ryczek E, White J, Poole RL, Reeves NL, Torkington J, Carolan-Rees G. Normothermic Insufflation to Prevent Perioperative Hypothermia and Improve Quality of Recovery in Elective Colectomy Patients: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 20;8(12):e14533. doi: 10.2196/14533. — View Citation

Scott AV, Stonemetz JL, Wasey JO, Johnson DJ, Rivers RJ, Koch CG, Frank SM. Compliance with Surgical Care Improvement Project for Body Temperature Management (SCIP Inf-10) Is Associated with Improved Clinical Outcomes. Anesthesiology. 2015 Jul;123(1):116-25. doi: 10.1097/ALN.0000000000000681. — View Citation

Sessler DI. Perioperative thermoregulation and heat balance. Lancet. 2016 Jun 25;387(10038):2655-2664. doi: 10.1016/S0140-6736(15)00981-2. Epub 2016 Jan 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of inadvertent perioperative hypothermia	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	September 15, 2022- September 15, 2023
Secondary	Following surgical site infection	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.	16 September 16, 2023 - October 25, 2023