Frailty Assessment of Patients With Gastrointestinal Surgery

Frail Elderly Syndrome Clinical Trial

Official title:

Application of Frailty Assessment in Elderly Patients Undergoing Gastrointestinal Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03930082
• Other study ID #: FA-PGS-2019
• Status: Enrolling by invitation
• Start date: January 1, 2019
• Est. completion date: January 1, 2021

Study information

• Verified date: November 2020
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Frail Elderly Syndrome
• Frailty
• Gastrointestinal Disease
• Gastrointestinal Diseases

Intervention

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

Locations

Country	Name	City	State
China	West China Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Ziqiang Wang,MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative time	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 year
Primary	Blood loss	intraoperative blood loss	2 year
Primary	Intraoperative complications	Including all the complications in the procedure	2 year
Primary	postoperative complications	including incision infection,anastomotic leakage,respiratory infection, postoperative bleeding and so on.	2 year
Primary	The length of stay in intensive care unit (ICU)	Time form entry to ICU to return to general ward after the condition is stable.	2 year
Primary	The length of hospitalization	Time from admission to discharge	2 year
Primary	Hospital costs	Cost of diagnosis and treatment during hospitalization	2 year
Primary	Readmission rate within 30 days	The proportion of patients who are re-hospitalized for postoperative complications after 30 days of discharge in all subjects.	2 year
Primary	Mortality within 30 days	death rate within 30 days after surgery in all patients after operation	2 year
Secondary	Recurrence-free Survival (RFS)	RFS is the abbreviation of recurrence-free survival, which refers to the duration from postoperation to tumor recurrence (Only for patients with cancers).	2 year
Secondary	Overall survival (OS)	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 year