Frailty and Postoperative Outcomes After Emergency General Surgery

July 14, 2016 updated by: Ottawa Hospital Research Institute
The investigators will examine the association between preoperative frailty and postoperative outcomes and resource utilization after emergency general surgery.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4E9
        • Ottawa Hospital Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Emergency General Surgery
All patients having emergency general surgery procedures as defined by Scott et al (JAMA Surgery 2016)
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 365 days (from date of surgery)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital length of stay
Time Frame: day of surgery to 365 days after surgery
Number of days in hospital from date of surgery to 365 days after surgery
day of surgery to 365 days after surgery
Intensive care unit admission
Time Frame: from date of surgery to 30 days after surgery
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
Institutional discharge
Time Frame: Date of surgery to hospital discharge or 365 days after surgery (at which time participants will be censored)
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)
Costs
Time Frame: day of surgery to 365 days after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

July 13, 2016

First Submitted That Met QC Criteria

July 14, 2016

First Posted (Estimate)

July 15, 2016

Study Record Updates

Last Update Posted (Estimate)

July 15, 2016

Last Update Submitted That Met QC Criteria

July 14, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • DM3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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