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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: October 2024

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.

Interventions

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

Arms, Groups and Cohorts

  • Frail, non-frail
    • Frail Group: Those individuals identified as frail by low hand-grip-strength and/or the Clinical Frailty Scale. Non-frail Group: Those individuals identified as not frail by hand-grip-strength and/or the Clinical Frailty Scale.

Clinical Trial Outcome Measures

Primary Measures

  • Time to death
    • Time Frame: Up to one year
    • Time until subject dies or up to one year after surgery

Secondary Measures

  • Postoperative complications
    • Time Frame: Up to 90 days after surgery
    • Complications as graded by the Clavien-Dindo system and defined by the EPCO-definitions.
  • Discharge to institution
    • Time Frame: Up to 90 days after surgery
    • Discharge to nursing home
  • Worsening functional status
    • Time Frame: 1 year postoperatively.
    • Increased need of assistance in performing ADL.
  • Mortality at 30 days
    • Time Frame: 30 days after surgery
    • Death within 30 days after surgery
  • Mortality at 90 days
    • Time Frame: 90 days after surgery
    • Death within 90 days after surgery

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 80 Years

Maximum Age: N/A

Investigator Details

  • Lead Sponsor
    • Haukeland University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ib Jammer, PhD, MD, Principal Investigator, Haukeland University Hospital

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