NCT03721471CompletedNot Applicable
Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty
Haukeland University Hospital1 site in 1 country144 target enrollmentStarted: October 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Time to death
Study Overview
Brief Summary
The aim of the study is to investigate the effect of frailty in patients ≥ 80 years admitted for elective major abdominal surgery.
Detailed Description
Patients ≥ 80 years admitted for elective major abdominal surgery will be asked to participate in this study where frailty will be scored using the Clinical Frailty Scale and by measuring hand-grip-strength.
Primary outcome is mortality at 30 days, 90 days and 1 year.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 80 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age 80 years or above
- •elective abdominal surgery
- •informed consent
Exclusion Criteria
- •age less than 80 years
- •emergency surgery
- •palliative surgery ( e.g performing entero-enteroanastomosis to relieve obstruction)
Outcomes
Primary Outcomes
Time to death
Time Frame: Up to one year
Time until subject dies or up to one year after surgery
Secondary Outcomes
- Postoperative complications(Up to 90 days after surgery)
- Discharge to institution(Up to 90 days after surgery)
- Mortality at 30 days(30 days after surgery)
- Worsening functional status(1 year postoperatively.)
- Mortality at 90 days(90 days after surgery)
Investigators
Study Sites (1)
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