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Risk factors for postoperative hypothermia in patients undergoing gynecologic robotic-assisted surgery: A retrospective study.

Status Approved

First Submitted Date

2021/01/21
Registered Date

2021/01/28
Last Updated Date

2021/06/02

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005837
Unique Protocol ID	2021-01-004
Public/Brief Title	Postoperative hypothermia in gynecologic robotic-assisted surgery
Scientific Title	Risk factors for postoperative hypothermia in patients undergoing gynecologic robotic-assisted surgery: A retrospective study.
Acronym	PHGRS
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KYUH 2021-01-004
Approval Date	2021-01-21
Institutional Review Board Name	Konyang University Hospital Institutional Review Board
Institutional Review Board Address	158, Gwanjeodong-ro, Seo-gu, Daejeon
Institutional Review Board Telephone	042-600-9057
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Seok-jin Lee
Title	Dr.
Telephone	+82-42-600-9312
Affiliation	Konyang University Hospital
Address	Department of Anaesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine,158, Gwanjeodong-ro, Seo-Gu, Daejeon, Korea 302-718
Contact Person for Public Queries
Name	Seok-jin Lee
Title	Dr.
Telephone	+82-42-600-9312
Affiliation	Konyang University Hospital
Address	Department of Anaesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine,158, Gwanjeodong-ro, Seo-Gu, Daejeon, Korea 302-718
Contact Person for Updating Information
Name	Seok-jin Lee
Title	Dr.
Telephone	+82-42-600-9312
Affiliation	Konyang University Hospital
Address	Department of Anaesthesiology and Pain medicine, Konyang University Hospital, Konyang University College of Medicine,158, Gwanjeodong-ro, Seo-Gu, Daejeon, Korea 302-718

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2021-01-22 Actual
Target Number of Participant	500
Primary Completion Date	2021-12-31 , Anticipated
Study Completion Date	2021-12-31 , Anticipated
Name of Study	Konyang University Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2021-01-22 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Konyang University Hospital
Organization Type	Medical Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Konyang University Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	The human thermoregulatory system allows slight changes in body temperature at 37 degrees to maintain metabolic functions. The thermoregulatory response of the autonomic nerve system works to keep the body's body temperature at an approximately constant value. When the body's central body temperature is lower than 36 degrees, it is called hypothermia. Hypothermia is classified as mild at 35-35.9 degrees, moderate at 34-34.9 degrees, and severe hypothermia below 33.9 degrees. The use of general anesthesia reduces the body's metabolic heat production and weakens the physiological thermoregulatory response. Most anesthetics cause changes in deep thermoregulation, inhibiting thermoregulatory responses to cold, such as vasoconstriction and muscle tremors. In addition, most of these anesthetics have vasodilating effects that are considered to be the cause of redistribution, a mechanism that causes hypothermia in the early stages of general anesthesia. This redistribution phenomenon and exposure of patients to low operating room temperatures are known to be the main factors in inducing hypothermia. Even mild hypothermia can lead to a poor prognosis, which can lead to delayed drug metabolism, increased surgical site infection, blood clotting disorder, increased blood transfusion requirements, myocardial ischemia, delayed recovery, and increased hospital stay. Anesthesiologists must actively intervene in hypothermic mechanisms during the surgery and recovery phase to prevent harmful effects. In particular, in the case of robotic surgery, hypothermia can be caused by a long operation time, a long preparation time after anesthesia, infusion of cold intravenous fluid, inhalation of anesthetic gas, and relatively large amount of CO2 gas. In addition, various surgeries using robots are being performed, researching the risk factors of hypothermia in patients who performed surgery using robots, and finding methods and measures to effectively prevent hypothermia so that patients can be safe and efficient. This study was planned with the intent to enable efficient anesthesia management.

Study Summary Information

Lay Summary

The human thermoregulatory system allows slight changes in body temperature at 37 degrees to maintain metabolic functions. The thermoregulatory response of the autonomic nerve system works to keep the body&#39;s body temperature at an approximately constant value. When the body&#39;s central body temperature is lower than 36 degrees, it is called hypothermia. Hypothermia is classified as mild at 35-35.9 degrees, moderate at 34-34.9 degrees, and severe hypothermia below 33.9 degrees. The use of general anesthesia reduces the body&#39;s metabolic heat production and weakens the physiological thermoregulatory response. Most anesthetics cause changes in deep thermoregulation, inhibiting thermoregulatory responses to cold, such as vasoconstriction and muscle tremors. In addition, most of these anesthetics have vasodilating effects that are considered to be the cause of redistribution, a mechanism that causes hypothermia in the early stages of general anesthesia. This redistribution phenomenon and exposure of patients to low operating room temperatures are known to be the main factors in inducing hypothermia. Even mild hypothermia can lead to a poor prognosis, which can lead to delayed drug metabolism, increased surgical site infection, blood clotting disorder, increased blood transfusion requirements, myocardial ischemia, delayed recovery, and increased hospital stay. Anesthesiologists must actively intervene in hypothermic mechanisms during the surgery and recovery phase to prevent harmful effects. In particular, in the case of robotic surgery, hypothermia can be caused by a long operation time, a long preparation time after anesthesia, infusion of cold intravenous fluid, inhalation of anesthetic gas, and relatively large amount of CO2 gas. In addition, various surgeries using robots are being performed, researching the risk factors of hypothermia in patients who performed surgery using robots, and finding methods and measures to effectively prevent hypothermia so that patients can be safe and efficient. This study was planned with the intent to enable efficient anesthesia management.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Others
Time Perspective	Retrospective
Target Number of Participant	500
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label normothermia group
Cohort/ Group 1	Cohort/Group Description From January 2018 to November 2020, the medical records of patients who underwent robotic surgery at the hospital were reviewed retrospectively. Patients with normal body temperature after surgery (36°C to 38°C at end of surgery) were included in the normal body temperature group.
Cohort/ Group 2	Cohort/Group Label hypothermia group
Cohort/ Group 2	Cohort/Group Description From January 2018 to November 2020, the medical records of patients who underwent robotic surgery at the hospital were reviewed retrospectively. Patients with postoperative hypothermia (below 36°C at end of surgery) were included in the hypothermia group.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Patients who underwent gynecologic robotic-assisted surgery at our hospital from January 2018 to November 2020.
Sampling Method	Non-probability sampling
Condition(s)/Problem(s)	* (S00-T98)Injury, poisoning and certain other consequences of external causes (T88.5)Other complications of anaesthesia Diseases of the genitourinary system, neoplasms, etc.
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description It is intended for patients over 19 years of age who underwent gynecologic robotic-assisted at our hospital from January 2018 to November 2020.
Exclusion Criteria	- When switching from robotic surgery to general surgery before surgery is complete - unrecorded body temperature
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	Risk factors of postoperative hypothermia
Timepoint	at end of surgery
Secondary Outcome(s) 1
Outcome	Incidence of postoperative hypothermia
Timepoint	at end of surgery

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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