Frailty Assessment of Patients With Gastrointestinal Surgery

NCT03930082 | Unknown

• 1 other identifier: FA-PGS-2019
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Disease; Frail Elderly Syndrome

Keywords

Gastrointestinal surgery; Frailty; Elder patient; Complication

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (2)

• Recurrence-free Survival (RFS)

  2 year

• Overall survival (OS)

  2 year

Interventions

Frailty Index Scale OTHER

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

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients whose age not less than 65 years;
• undergoing operation in gastrointestinal surgery of West China hospital due to gastrointestinal disease.

You may not qualify if:

• Those who did not undergo surgery for various reasons;
• Death before operation

Sponsors & Collaborators

• Ziqiang Wang,MD: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Gastrointestinal Diseases; Frailty

Condition Hierarchy (Ancestors)

Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ziqiang Wang, MD,PHD

  Department of Gastrointestinal Surgery, West China Hospital, Sichuan University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: April 29, 2019
• Study Start: January 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)