NCT02835053

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2002

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 15, 2016

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

11.9 years

First QC Date

July 13, 2016

Last Update Submit

July 14, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Hospital length of stay

    day of surgery to 365 days after surgery

  • Intensive care unit admission

    from date of surgery to 30 days after surgery

  • Institutional discharge

    Date of surgery to hospital discharge or 365 days after surgery (at which time participants will be censored)

  • Costs

    day of surgery to 365 days after surgery

Study Arms (1)

Emergency General Surgery

All patients having emergency general surgery procedures as defined by Scott et al (JAMA Surgery 2016)

Other: Frailty

Interventions

FrailtyOTHER

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

Emergency General Surgery

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All adult residents of Ontario 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)

You may qualify if:

  • 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)

You may not qualify if:

  • No valid provincial health insurance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 15, 2016

Study Start

April 1, 2002

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

July 15, 2016

Record last verified: 2016-07

Locations