Frailty Assessment of Patients With Gastrointestinal Surgery

Application of Frailty Assessment in Elderly Patients Undergoing Gastrointestinal Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Frail Elderly Syndrome; Gastrointestinal Disease
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Elderly patients aged 65 years or older who undergo gastrointestinal surgery in West China Hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Blood loss	intraoperative blood loss	2 year
Intraoperative complications	Including all the complications in the procedure	2 year
postoperative complications	including incision infection，anastomotic leakage，respiratory infection, postoperative bleeding and so on.	2 year
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
The length of hospitalization	Time from admission to discharge	2 year
Hospital costs	Cost of diagnosis and treatment during hospitalization	2 year
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
Mortality within 30 days	death rate within 30 days after surgery in all patients after operation	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (Actual): April 29, 2019

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 11, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Frailty; Complication; Gastrointestinal surgery; Elder patient
• Additional Relevant MeSH Terms: Pathologic Processes; Frailty; Gastrointestinal Diseases; Digestive System Diseases
• Other Study ID Numbers: FA-PGS-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No