Clinical trial NCT06035627: The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.
Official title: Uncontrolled Inadvertent Perioperative Hypothermia as a Risk Factor for Surgical Site Infection in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Site Infection
Perioperative Complication
Keywords: inadvertent perioperative hypothermia
surgical site infection
laparoscopic cholecystectomies
perioperative nursing
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: laparoscopic cholecystectomy patients who met the inclusion and exclusion criteria

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.

Eligibility 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.

Primary outcomes:
measure: Prevention of inadvertent perioperative hypothermia
timeFrame: September 15, 2022- September 15, 2023
Secondary outcomes:
measure: Following surgical site infection
timeFrame: 16 September 16, 2023 - October 25, 2023
Other outcomes:
Locations:
city: Sivas
country: Turkey
facility: Cumhuriyet University
state: Suşehri
city: Sivas
country: Turkey
facility: Sivas Cumhuriyet University
Study officials:
affiliation: corresponding researcher
name: Pınar YILMAZ EKER, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
citation: 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.