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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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laparoscopic cholecystectomy patients who met the inclusion and exclusion criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pınar YILMAZ EKER, Ph.D. | Contact | +905309468919 | yilmazpinar20@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Pınar YILMAZ EKER, Ph.D | corresponding researcher | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cumhuriyet University | Recruiting | Sivas | Suşehri | 58140 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28527547 | Background | 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. | |
| 26555870 | 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. |
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| ID | Term |
|---|---|
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
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| Sivas Cumhuriyet University | Recruiting | Sivas | 58140 | Turkey (Türkiye) |
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| 25909970 | 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. |
| 26775126 | 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. |
| 31859685 | 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. |
| 34555101 | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |