Clinical trial NCT03930082: Frailty Assessment of Patients With Gastrointestinal Surgery
Official title: Application of Frailty Assessment in Elderly Patients Undergoing Gastrointestinal Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastrointestinal Disease
Frail Elderly Syndrome
Keywords: Gastrointestinal surgery
Frailty
Elder patient
Complication
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 500
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Elderly patients aged 65 years or older who undergo gastrointestinal surgery in 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.

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.

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

Primary outcomes:
measure: operative time
timeFrame: 2 year
measure: Blood loss
timeFrame: 2 year
measure: Intraoperative complications
timeFrame: 2 year
measure: postoperative complications
timeFrame: 2 year
measure: The length of stay in intensive care unit (ICU)
timeFrame: 2 year
measure: The length of hospitalization
timeFrame: 2 year
measure: Hospital costs
timeFrame: 2 year
measure: Readmission rate within 30 days
timeFrame: 2 year
measure: Mortality within 30 days
timeFrame: 2 year
Secondary outcomes:
measure: Recurrence-free Survival (RFS)
timeFrame: 2 year
measure: Overall survival (OS)
timeFrame: 2 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: Department of Gastrointestinal Surgery, West China Hospital, Sichuan University
name: Ziqiang Wang, MD,PHD
role: STUDY_CHAIR
References: