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Clinical Trials/NCT03930082
NCT03930082
Unknown
Not Applicable

Application of Frailty Assessment in Elderly Patients Undergoing Gastrointestinal Surgery

Ziqiang Wang,MD1 site in 1 country500 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gastrointestinal Disease
Sponsor
Ziqiang Wang,MD
Enrollment
500
Locations
1
Primary Endpoint
Blood loss
Last Updated
5 years ago

Overview

Brief Summary

Patients aged 65 or older under gastrointestinal surgery will be enrolled,the investigators will assess the frailty of these patients by Frailty Index Scale and explore the correlation between the frailty and perioperative adverse events.

Detailed Description

Patients will be assessed by specially trained doctors or nurses after admission, including daily living ability, physiological function, social-psychological status, comorbidities, mental state, grip strength, walking speed. After the assessment, the patients' frailty index was obtained. Moreover, the operation time, intraoperative bleeding loss, perioperative complications, length of stay, hospitalization expenses, readmission rate within 30 days, mortality within 30 days and other outcome indicators of these patients will be recorded. The Main purposes of present study are to verify the feasibility of applying Frailty Index (FI) to assess the degree of frailty in elderly patients undergoing gastrointestinal surgery, compare the difference of perioperative adverse events in elderly patients with different degrees of frailty,find potential indicators for evaluating and predicting the safety of surgery in elderly patients, and provide reference data for the determination of future assessment tools of frailty. The secondary objective is to compare the quality of life and long-term prognosis(only for patients with cancers,including recurrence free survival and overall survival) of elderly patients with different degrees of frailty after gastrointestinal surgery.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
January 1, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Ziqiang Wang,MD
Responsible Party
Sponsor Investigator
Principal Investigator

Ziqiang Wang,MD

Clinical professor

West China Hospital

Eligibility Criteria

Inclusion Criteria

  • Patients whose age not less than 65 years;
  • undergoing operation in gastrointestinal surgery of West China hospital due to gastrointestinal disease.

Exclusion Criteria

  • Those who did not undergo surgery for various reasons;
  • Death before operation

Outcomes

Primary Outcomes

Blood loss

Time Frame: 2 year

intraoperative blood loss

postoperative complications

Time Frame: 2 year

including incision infection,anastomotic leakage,respiratory infection, postoperative bleeding and so on.

The length of stay in intensive care unit (ICU)

Time Frame: 2 year

Time form entry to ICU to return to general ward after the condition is stable.

operative time

Time Frame: 2 year

From the beginning of the skin incision to the end of the last incision was From the beginning of the skin incision to the end of the suture of last incision

The length of hospitalization

Time Frame: 2 year

Time from admission to discharge

Hospital costs

Time Frame: 2 year

Cost of diagnosis and treatment during hospitalization

Readmission rate within 30 days

Time Frame: 2 year

The proportion of patients who are re-hospitalized for postoperative complications after 30 days of discharge in all subjects.

Intraoperative complications

Time Frame: 2 year

Including all the complications in the procedure

Mortality within 30 days

Time Frame: 2 year

death rate within 30 days after surgery in all patients after operation

Secondary Outcomes

  • Recurrence-free Survival (RFS)(2 year)
  • Overall survival (OS)(2 year)

Study Sites (1)

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