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Completed

NCT Number: NCT03721471

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

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

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Key information

Conditions

Frail Elderly Syndrome Surgery--Complications

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Scoring of frailty

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

Primary outcomes

  1. Time to death

    Time frame: Up to one year

    Time until subject dies or up to one year after surgery

Secondary outcomes

  1. Postoperative complications

    Time frame: Up to 90 days after surgery

    Complications as graded by the Clavien-Dindo system and defined by the EPCO-definitions.

  2. Discharge to institution

    Time frame: Up to 90 days after surgery

    Discharge to nursing home

  3. Worsening functional status

    Time frame: 1 year postoperatively.

    Increased need of assistance in performing ADL.

  4. Mortality at 30 days

    Time frame: 30 days after surgery

    Death within 30 days after surgery

  5. Mortality at 90 days

    Time frame: 90 days after surgery

    Death within 90 days after surgery

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Oct 26, 2018
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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