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Frailty Assessment of Patients With Gastrointestinal Surgery

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ClinicalTrials.gov Identifier: NCT03930082
Recruitment Status : Recruiting
First Posted : April 29, 2019
Last Update Posted : April 29, 2019
Sponsor:
Information provided by (Responsible Party):
Ziqiang Wang,MD, West China Hospital

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.

Condition or disease Intervention/treatment
Gastrointestinal Disease Frail Elderly Syndrome Other: Frailty Index Scale

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Application of Frailty Assessment in Elderly Patients Undergoing Gastrointestinal Surgery
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2021
Estimated Study Completion Date : January 1, 2021

Intervention Details:
  • Other: Frailty Index Scale
    We will evaluate the frailty with a Frailty Index Scale in elderly patients undergoing gastrointestinal surgery.


Primary Outcome Measures :
  1. 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

  2. Blood loss [ Time Frame: 2 year ]
    intraoperative blood loss

  3. Intraoperative complications [ Time Frame: 2 year ]
    Including all the complications in the procedure

  4. postoperative complications [ Time Frame: 2 year ]
    including incision infection,anastomotic leakage,respiratory infection, postoperative bleeding and so on.

  5. 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.

  6. The length of hospitalization [ Time Frame: 2 year ]
    Time from admission to discharge

  7. Hospital costs [ Time Frame: 2 year ]
    Cost of diagnosis and treatment during hospitalization

  8. 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.

  9. Mortality within 30 days [ Time Frame: 2 year ]
    death rate within 30 days after surgery in all patients after operation


Secondary Outcome Measures :
  1. Recurrence-free Survival (RFS) [ Time Frame: 2 year ]
    RFS is the abbreviation of recurrence-free survival, which refers to the duration from postoperation to tumor recurrence (Only for patients with cancers).

  2. Overall survival (OS) [ Time Frame: 2 year ]
    OS is the abbreviation of overall survival , which refers to the duration from postoperation to death of the subjects (Only for patients with cancers).



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Elderly patients aged 65 years or older who undergo gastrointestinal surgery in West China Hospital.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03930082


Contacts
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Contact: Ziqiang Wang, MD,PHD +8618980602028 604204486@qq.com

Locations
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China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, 610041
Contact: Ziqiang Wang, MD,PHD    +8618980602028    604204486@qq.com   
Principal Investigator: Chaoyang Gu, MD         
Sponsors and Collaborators
Ziqiang Wang,MD
Investigators
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Study Chair: Ziqiang Wang, MD,PHD Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
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Responsible Party: Ziqiang Wang,MD, Clinical professor, West China Hospital
ClinicalTrials.gov Identifier: NCT03930082    
Other Study ID Numbers: FA-PGS-2019
First Posted: April 29, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ziqiang Wang,MD, West China Hospital:
Gastrointestinal surgery
Frailty
Elder patient
Complication
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Frailty
Digestive System Diseases
Pathologic Processes