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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06035627
Enrollment
100
Registered
2023-09-13
Start date
2023-05-15
Completion date
2024-08-15
Last updated
2023-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Complication, Surgical Site Infection

Keywords

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

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.

Interventions

OTHERPrevention hypothermia

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

Sponsors

Cumhuriyet University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Prevention of inadvertent perioperative hypothermiaSeptember 15, 2022- September 15, 2023This 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

Secondary

MeasureTime frameDescription
Following surgical site infection16 September 16, 2023 - October 25, 2023After 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.

Countries

Turkey (Türkiye)

Contacts

Primary ContactPınar YILMAZ EKER, Ph.D.
yilmazpinar20@gmail.com+905309468919

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026