- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02835053
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
Conditions
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
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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
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Intensive care unit admission
Time Frame: from date of surgery to 30 days after surgery
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Presence of a special care unit admission from the Discharge abstract database from the date of surgery to 30 days after surgery
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from date of surgery to 30 days after surgery
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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
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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
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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
Additional Relevant MeSH Terms
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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