Frailty and Postoperative Outcomes After Emergency General Surgery

Geriatrics Clinical Trial

Official title:

Frailty and Postoperative Outcomes After Emergency General Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02835053
• Other study ID #: DM3
• Status: Completed
• Phase: N/A
• First received: July 13, 2016
• Last updated: July 14, 2016
• Start date: April 2002
• Est. completion date: March 2014

Study information

• Verified date: July 2016
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators will examine the association between preoperative frailty and postoperative outcomes and resource utilization after emergency general surgery.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150000
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• All residents of Ontario aged more than 65 years on their surgery date with valid provincial health insurance who have an emergency general surgery procedure (large bowel surgery, small bowel surgery, cholecystectomy, control of hemorrhage from duodenal ulcer, lysis of adhesions, appendectomy, laparotomy)

Exclusion Criteria:

• No valid provincial health insurance

Related Conditions & MeSH terms

• Emergencies
• General Surgery
• Geriatrics
• Outcomes Research

Intervention

Other:
• Frailty
Participants will be defined as frail based on the Johns Hopkins ACG Frailty Defining Diagnoses Indicator, which will be applied to available health administrative data in the 3 years preceding index hospital admission. If no frailty defining diagnoses are present participants will be defined as not frail

Locations

Country	Name	City	State
Canada	Ottawa Hospital Research Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Mortality events will be identified from the registered person's database in Ontario from the date of surgery to 365 days after surgery, at which time participants will be censored	365 days (from date of surgery)
Secondary	Hospital length of stay	Number of days in hospital from date of surgery to 365 days after surgery	day of surgery to 365 days after surgery
Secondary	Intensive care unit admission	Presence of a special care unit admission from the Discharge abstract database from the date of surgery to 30 days after surgery	from date of surgery to 30 days after surgery
Secondary	Institutional discharge	Discharge disposition to an institution in the discharge abstract database	Date of surgery to hospital discharge or 365 days after surgery (at which time participants will be censored)
Secondary	Costs	Total costs incurred by the provincial health care system from the day of surgery to 365 days after surgery	day of surgery to 365 days after surgery