The Effect of Inadvertent Perioperative Hypothermia on Surgical Site Infection in Laparoscopic Choleistectomy.
NCT ID: NCT06035627
Last Updated: 2023-09-13
Study Results
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Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2023-05-15
2024-08-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
Yes
Sponsors
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Cumhuriyet University
OTHER
Responsible Party
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Pınar YILMAZ EKER
Asst. Prof
Principal Investigators
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Pınar YILMAZ EKER, Ph.D
Role: PRINCIPAL_INVESTIGATOR
corresponding researcher
Locations
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Cumhuriyet University
Sivas, Suşehri, Turkey (Türkiye)
Sivas Cumhuriyet University
Sivas, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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PYILMAZEKER
Identifier Type: -
Identifier Source: org_study_id
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