Protocol summary
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Study aim
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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
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Design
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Observational research
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Settings and conduct
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The sublinguinal temperature of patients will be measured before anesthesia induction (standard intravenous induction and then inhalation anesthesia) every 5 minutes during surgery.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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Patients who will undergo laparoscopic and open surgery practice training
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Main outcome variables
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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
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Reason for update
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data collection was terminated because sufficient number of patients was reached
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20221109056453N1
Registration date:
2023-03-26, 1402/01/06
Registration timing:
registered_while_recruiting
Last update:
2023-07-31, 1402/05/09
Update count:
1
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Registration date
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2023-03-26, 1402/01/06
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-01-01, 1401/10/11
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Expected recruitment end date
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2024-01-01, 1402/10/11
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Actual recruitment start date
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2023-02-01, 1401/11/12
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Actual recruitment end date
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2023-07-31, 1402/05/09
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Trial completion date
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empty
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Scientific title
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Comparison of the changes of body temperatures in laparoscopic and open surgeries. Single center, observational research
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Public title
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Comparison of the changes of body temperatures in laparoscopic and open surgeries. Single center, observational research
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Purpose
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Other
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 65 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
60
Actual sample size reached:
60
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2022-11-22, 1401/09/01
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Ethics committee reference number
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2022-21/180
Health conditions studied
1
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Description of health condition studied
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hypothermia
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ICD-10 code
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T88.51
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ICD-10 code description
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Hypothermia following anesthesia
Primary outcomes
1
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Description
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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
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Timepoint
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each five-minutes during the surgical procedure
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Method of measurement
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Body temperature measurements will be made sublinguinally during the surgical procedure with the temperature probe in Mindray Vato-Ex (Mindray, Beejing, China) monitor systems
Intervention groups
1
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Description
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Control group: Patients who will undergo laparoscopic inguinal hernia surgery
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Category
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Early detection
2
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Description
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Intervention group: Patients who will undergo open technique inguinal hernia surgery
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Category
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Early detection
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Department of Anaesthesiology and Reanimation, Ahi Evran University Faculty of Medicine
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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There is no further information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available