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.

Study Overview

• Status: Completed
• Conditions: Frail Elderly Syndrome; Surgery--Complications
• Intervention / Treatment: Other: Scoring of frailty

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 Type: Observational
• Enrollment (Actual): 144

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5021
    • Haukeland University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 80 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients ≥ 80 years admitted for elective major abdominal surgery at Haukeland University Hospital, Bergen, Norway.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Scoring of frailty; Patients will be scored by the Clinical frailty Scale; Patients' hand-grip-strength will be measured by a dynamometer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to death	Time until subject dies or up to one year after surgery	Up to one year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Haukeland University Hospital
• Investigators: Principal Investigator: Ib Jammer, PhD, MD, Haukeland University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2018
• Primary Completion (Actual): October 2, 2024
• Study Completion (Actual): October 2, 2024

Study Registration Dates

• First Submitted: October 2, 2018
• First Submitted That Met QC Criteria: October 24, 2018
• First Posted (Actual): October 26, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2024
• Last Update Submitted That Met QC Criteria: October 2, 2024
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 2018/315

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make IPD available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No