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NCT03721471 Clinical Trial

Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty

Surgery--Complications Clinical Trial

Official title:
Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03721471
Other study ID # 2018/315
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date October 2024

Study information
Verified date November 2022
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The aim of the study is to investigate the effect of frailty in patients ≥ 80 years admitted for elective major abdominal surgery.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 144
Est. completion date October 2024
Est. primary completion date October 2024
Accepts healthy volunteers
Gender All
Age group 80 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Scoring of frailty
Patients will be scored by the Clinical frailty Scale Patients' hand-grip-strength will be measured by a dynamometer.

Locations
Country Name City State
Norway Haukeland University Hospital Bergen

Sponsors (1)
Lead Sponsor Collaborator
Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to death Time until subject dies or up to one year after surgery Up to one year
Secondary Postoperative complications Complications as graded by the Clavien-Dindo system and defined by the EPCO-definitions. Up to 90 days after surgery
Secondary Discharge to institution Discharge to nursing home Up to 90 days after surgery
Secondary Worsening functional status Increased need of assistance in performing ADL. 1 year postoperatively.
Secondary Mortality at 30 days Death within 30 days after surgery 30 days after surgery
Secondary Mortality at 90 days Death within 90 days after surgery 90 days after surgery
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