General SurgeryNCT02835053
Frailty and Postoperative Outcomes After Emergency General Surgery
An observational study of General Surgery and Geriatrics, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The investigators will examine the association between preoperative frailty and postoperative outcomes and resource utilization after emergency general surgery. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- General Surgery, Geriatrics, Outcomes Research
- What is being tested?
- Frailty
- How many people
- 150,000 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2002to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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)
Who may be able to join
- 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)
Who cannot join
- No valid provincial health insurance
Trial locations and contacts
1 site in 1 country.
About this study
The investigators will examine the association between preoperative frailty and postoperative outcomes and resource utilization after emergency general surgery.
- Conditions
- General Surgery, Geriatrics, Outcomes Research
- Being tested
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Emergency General Surgery | All patients having emergency general surgery procedures as defined by Scott et al (JAMA Surgery 2016) Receives: Other: Frailty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 365 days (from date of surgery)
Secondary outcomes (4)
Hospital length of stay
Number of days in hospital from date of surgery to 365 days after surgery
Measured: day of surgery to 365 days after surgery
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
Measured: from date of surgery to 30 days after surgery
Institutional discharge
Discharge disposition to an institution in the discharge abstract database
Measured: Date of surgery to hospital discharge or 365 days after surgery (at which time participants will be censored)
Costs
Total costs incurred by the provincial health care system from the day of surgery to 365 days after surgery
Measured: day of surgery to 365 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2016 (estimated)
- Study startApr 2002
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General SurgeryStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 150,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02835053
- Sponsor's protocol ID
- DM3
- Status last verified
- Jul 2016
- First submitted
- 13 Jul 2016
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty and Postoperative Outcomes After Emergency General Surgery
- ClinicalTrials.gov ID
- NCT02835053
- Acronym / sponsor ID
- DM3
- Conditions
- General Surgery, Geriatrics, Outcomes Research
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150,000 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2002
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 15 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will examine the association between preoperative frailty and postoperative outcomes and resource utilization after emergency general surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Emergency General Surgery | – | Other: FrailtyAll patients having emergency general surgery procedures as defined by Scott et al (JAMA Surgery 2016) |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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)
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- No valid provincial health insurance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FrailtyParticipants 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 | Other | Emergency General Surgery |
Primary outcome
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
4 secondary outcomes
Hospital length of stay
Time frame: day of surgery to 365 days after surgery
Intensive care unit admission
Time frame: 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)
Costs
Time frame: day of surgery to 365 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of General Surgery and Geriatrics, run by Ottawa Hospital Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 365 days (from date of surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2016; AzTrials last refreshed its copy on 6 Nov 2026.