The primary aim of our research is; To compare the amount of change in body temperature in laparoscopic and open surgery applications. The secondary aim is to compare the frequency of hypothermia among these groups
Design
Observational research
Settings and conduct
The sublinguinal temperature of patients will be measured before anesthesia induction (standard intravenous induction and then inhalation anesthesia) every 5 minutes during surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients who will undergo elective surgery for unilateral inguinal hernia, Society of Anesthesiology (ASA) risk group I-III, Between the ages of 18-65
Exclusion criteria: Patients with congenital or acquired neurological disease, Patients who are being treated for thyroid dysfunction, Patients whose body temperature was found to be below 36 °C before the start of the surgical procedure, Bilateral inguinal hernia surgery will be performed, Patients who require emergency surgery
Intervention groups
Patients who will undergo laparoscopic and open surgery practice training
Main outcome variables
To compare the amount of change in body temperature in laparoscopic and open surgery applications and the temperature measured each five-minutes during the surgical procedure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221109056453N1
Registration date:2023-03-26, 1402/01/06
Registration timing:registered_while_recruiting
Last update:2023-03-26, 1402/01/06
Update count:1
Registration date
2023-03-26, 1402/01/06
Registrant information
Name
guzin ceran
Name of organization / entity
Kirsehir training and research hospital
Country
Turkey
Phone
+90 386 213 45 15
Email address
gzncrn@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-01, 1401/10/11
Expected recruitment end date
2024-01-01, 1402/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the changes of body temperatures in laparoscopic and open surgeries. Single center, observational research
Public title
Comparison of the changes of body temperatures in laparoscopic and open surgeries. Single center, observational research
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who will undergo surgery for unilateral inguinal hernia
Elective cases
Society of Anesthesiology (ASA) risk group I-III
Between the ages of 18-65
Exclusion criteria:
Patients with congenital or acquired neurological disease
Patients who are being treated for thyroid dysfunction
Patients whose body temperature was found to be below 36 °C before the start of the surgical procedure
Bilateral inguinal hernia surgery will be performed
Patients who require emergency surgery
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kirsehir ahi evran medical faculity ethics committee
Street address
Bağbaşı Mah. Sahir Kurutluoğlu Cad. No: 100 Merkez / KIRŞEHİR
City
kirsehir
Postal code
40200
Approval date
2022-11-22, 1401/09/01
Ethics committee reference number
2022-21/180
Health conditions studied
1
Description of health condition studied
hypothermia
ICD-10 code
T88.51
ICD-10 code description
Hypothermia following anesthesia
Primary outcomes
1
Description
To compare the amount of change in body temperature in laparoscopic and open surgery applications and the temperature measured each five-minutes during the surgical procedure
Timepoint
each five-minutes during the surgical procedure
Method of measurement
Body temperature measurements will be made sublinguinally during the surgical procedure with the temperature probe in Mindray Vato-Ex (Mindray, Beejing, China) monitor systems
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Patients who will undergo laparoscopic inguinal hernia surgery
Category
Early detection
2
Description
Intervention group: Patients who will undergo open technique inguinal hernia surgery
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Anaesthesiology and Reanimation, Kirsehir Training and Research Hospital