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

NCT03721471 | Completed

• 1 other identifier: 2018/315
• Study Type: observational
• Target: 144
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Frail Elderly Syndrome; Surgery--Complications

Outcome Measures

Primary Outcomes (1)

• Time to death

  Time until subject dies or up to one year after surgery

  Up to one year

Secondary Outcomes (5)

• Postoperative complications

  Up to 90 days after surgery

• Discharge to institution

  Up to 90 days after surgery

• Worsening functional status

  1 year postoperatively.

• Mortality at 30 days

  30 days after surgery

• Mortality at 90 days

  90 days after surgery

Study Arms (1)

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

Interventions

Scoring of frailty OTHER

1. Patients will be scored by the Clinical frailty Scale 2. Patients' hand-grip-strength will be measured by a dynamometer.

Frail, non-frail

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• age 80 years or above
• elective abdominal surgery
• informed consent

You may not qualify if:

• age less than 80 years
• emergency surgery
• palliative surgery ( e.g performing entero-enteroanastomosis to relieve obstruction)

Sponsors & Collaborators

• Haukeland University Hospital: lead

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Study Officials

• Ib Jammer, PhD, MD

  Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 26, 2018
• Study Start: October 1, 2018
• Primary Completion: October 2, 2024
• Study Completion: October 2, 2024
• Last Updated: October 4, 2024

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)