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Functional recovery and prognosis according to resilience in older surgical patients after partial pancreatectomy

Status Approved

First Submitted Date

2021/03/22
Registered Date

2021/03/30
Last Updated Date

2021/02/25

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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	KCT0006041
Unique Protocol ID	B-2007-622-301
Public/Brief Title	Functional recovery and prognosis according to resilience in older surgical patients after partial pancreatectomy
Scientific Title	Functional recovery and prognosis according to resilience in older surgical patients after partial pancreatectomy
Acronym	Resilience
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	B-2007/622-301
Approval Date	2020-07-20
Institutional Review Board Name	Seoul National University Bundang Hospital Institutional Review Board
Institutional Review Board Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
Institutional Review Board Telephone	031-787-8801
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	Kwang-il Kim
Title	Professor
Telephone	+82-31-787-7032
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Public Queries
Name	Jung-yeon Choi
Title	Assistant professor
Telephone	+82-31-787-8131
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea
Contact Person for Updating Information
Name	Jung-yeon Choi
Title	Assistant professor
Telephone	+82-31-787-8131
Affiliation	Seoul National University Bundang Hospital
Address	82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea

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	2020-09-08 Actual
Target Number of Participant	100
Primary Completion Date	2022-12-31 , Anticipated
Study Completion Date	2023-06-30 , Anticipated
Name of Study	Seoul National University Bundang Hospital
Recruitment Status	Recruiting
Date of First Enrollment	2020-09-08 ,

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	Seoul National University Bundang Hospital
Organization Type	Medical Institute
Project ID	14-2020-027

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Seoul National University Bundang Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	In older patients, it is necessary to measure the actual physiological reserves that precede the geriatric syndrome, such as frailty or sarcopenia before surgery. Therefore, this study aims to develop and verify a methodology for measuring resilience, which is a decrease in physiological reserve capacity that precedes frailty by studying elderly patients who have undergone pancreatectomy.

Study Summary Information

Lay Summary

In older patients, it is necessary to  measure the actual physiological reserves that precede the geriatric syndrome, such as frailty or sarcopenia before surgery. Therefore, this study aims to develop and verify a methodology for measuring resilience, which is a decrease in physiological reserve capacity that precedes frailty by studying elderly patients who have undergone pancreatectomy.

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	Cohort
Time Perspective	Prospective
Target Number of Participant	100
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Observational Cohort
Cohort/ Group 1	Cohort/Group Description Preoperative resilience, comprehensive geriatric assessment, and sarcopenia are evaluated before surgery. Postoperative complications, functional recovery at 2 weeks and 3,6 months were evaluated, and changes in frailty and sarcopenia after 1 year, and survival at 1,3,5 years will be assessed.
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Those 65 years of age or older who are scheduled for pancreatectomy and who are conducted or are planning to conduct preoperative comprehensive geriatric assessment.
Sampling Method	Patients who agree with participating in the study after enough explanation of patients who are scheduled for pancreatectomy.
Condition(s)/Problem(s)	* (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC (R54)Senility Frailty Sarcopenia Functional Status
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 65Year~No Limit
	Description Patients whose age 65 years or older Those who are scheduled for pancreatectomy at Seoul National University Bundang Hospital Those who have performed or are expected to perform a preoperative comprehensive geriatric assessment Patients who are agreed to participate study with informed consent
Exclusion Criteria	Those with an MMSE score ≤ 15 (If there is a past evaluation result) Moderate or severe dementia is diagnosed
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	Functional status changes after surgery
Timepoint	Two weeks, 3 months, 6 months after surgery
Secondary Outcome(s) 1
Outcome	Postoperative complication
Timepoint	During hospital stay for surgery
Secondary Outcome(s) 2
Outcome	Survival for 1, 3 and 5 years after surgery
Timepoint	1, 3 and 5 years after surgery
Secondary Outcome(s) 3
Outcome	Frailty
Timepoint	Before surgery and 1 year after surgery
Secondary Outcome(s) 4
Outcome	Sarcopenia
Timepoint	Before surgery and 1 year after surgery
Secondary Outcome(s) 5
Outcome	Quality of life
Timepoint	Before surgery and 1 year after 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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