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

NCT06035627 | Unknown

• 1 other identifier: PYILMAZEKER
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgical Site Infection; Perioperative Complication

Keywords

inadvertent perioperative hypothermia; surgical site infection; laparoscopic cholecystectomies; perioperative nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Following surgical site infection

  16 September 16, 2023 - October 25, 2023

Study Arms (2)

Experimental group

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.

Other: Prevention hypothermia

Control group

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.

Interventions

Prevention hypothermia OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

laparoscopic cholecystectomy patients who met the inclusion and exclusion criteria

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cumhuriyet University: lead

Study Sites (2)

Cumhuriyet University

Sivas, Suşehri, 58140, Turkey (Türkiye)

RECRUITING

Sivas Cumhuriyet University

Sivas, 58140, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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.

  PMID: 28527547 BACKGROUND

• 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.

  PMID: 26555870 BACKGROUND

• 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.

  PMID: 25909970 BACKGROUND

• 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.

  PMID: 26775126 BACKGROUND

• 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.

  PMID: 31859685 BACKGROUND

• 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.

  PMID: 34555101 BACKGROUND

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pınar YILMAZ EKER, Ph.D

  corresponding researcher

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pınar YILMAZ EKER, Ph.D.

CONTACT

+905309468919; yilmazpinar20@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst. Prof

Study Record Dates

• First Submitted: August 28, 2023
• First Posted: September 13, 2023
• Study Start: May 15, 2023
• Primary Completion: May 15, 2024
• Study Completion: August 15, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

TU (2)