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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Frailty Assessment of Patients With Gastrointestinal Surgery

Clinicaltrials.gov identifier NCT03930082

Recruitment Status Enrolling by invitation

First Posted April 29, 2019

Last update posted November 13, 2020

Study Description

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:Gastrointestinal Disease
    Frail Elderly Syndrome
  • Intervention/Treatment: Other: Frailty Index Scale
  • Phase: N/A
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.

Study Design
  • 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 2019
  • Estimated Primary Completion Date: January 2021
  • Estimated Study Completion Date: January 2021
Outcome Measures
  • 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. 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).
  • 2. 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).
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

China, Sichuan
West China Hospital, Sichuan University
Chengdu

Sponsors and Collaborators

Ziqiang Wang,MD

Investigators

Study Chair: Ziqiang Wang, MD,PHD Department of Gastrointestinal Surgery, West China Hospital, Sichuan University

More Information
  • Responsible Party: Ziqiang Wang,MD
  • ClinicalTrials.gov Identifier: NCT03930082 History of Changes
  • Other Study ID Numbers: FA-PGS-2019
  • First Posted: April 29, 2019 Key Record Dates
  • Last Update Posted: November 13, 2020
  • Last Verified: November 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Ziqiang Wang,MD: Gastrointestinal surgery
    Frailty
    Elder patient
    Complication
  • Additional relevant MeSH terms: Gastrointestinal Diseases
    Digestive System Diseases
    Frailty