Frailty Assessment of Patients With Gastrointestinal Surgery

• Conditions: Gastrointestinal Disease; Frail Elderly Syndrome

• Registration Number: NCT03930082
• Lead Sponsor: Ziqiang Wang,MD

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.

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-29
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-11
• Last Update Posted: 2020-11-13
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Blood loss	2 year	intraoperative blood loss
postoperative complications	2 year	including incision infection，anastomotic leakage，respiratory infection, postoperative bleeding and so on.
The length of stay in intensive care unit (ICU)	2 year	Time form entry to ICU to return to general ward after the condition is stable.
operative time	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	2 year	Time from admission to discharge
Hospital costs	2 year	Cost of diagnosis and treatment during hospitalization
Readmission rate within 30 days	2 year	The proportion of patients who are re-hospitalized for postoperative complications after 30 days of discharge in all subjects.
Intraoperative complications	2 year	Including all the complications in the procedure
Mortality within 30 days	2 year	death rate within 30 days after surgery in all patients after operation

Secondary Outcome Measures

Name	Time	Method
Recurrence-free Survival (RFS)	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).
Overall survival (OS)	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).

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China