Frail Elderly SyndromeNCT03721471
Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty
An observational study of Frail Elderly Syndrome and Surgery--Complications, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
The aim of the study is to investigate the effect of frailty in patients ≥ 80 years admitted for elective major abdominal surgery. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Surgery--Complications
- What is being tested?
- Scoring of frailty
- How many people
- 144 participants
- Where
- 1 siteNorway
- Study dates
- 1 Oct 2018to 2 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- Older adult
Study population: Patients ≥ 80 years admitted for elective major abdominal surgery at Haukeland University Hospital, Bergen, Norway.
Who may be able to join
- age 80 years or above
- elective abdominal surgery
- informed consent
Who cannot join
- age less than 80 years
- emergency surgery
- palliative surgery ( e.g performing entero-enteroanastomosis to relieve obstruction)
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to investigate the effect of frailty in patients ≥ 80 years admitted for elective major abdominal surgery.
Read the 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.
- Conditions
- Frail Elderly Syndrome, Surgery--Complications
- Being tested
- Scoring of frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scoring of frailtyOther
- Patients will be scored by the Clinical frailty Scale
- Patients' hand-grip-strength will be measured by a dynamometer.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Scoring of frailty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to death
Time until subject dies or up to one year after surgery
Measured: Up to one year
Secondary outcomes (5)
Postoperative complications
Complications as graded by the Clavien-Dindo system and defined by the EPCO-definitions.
Measured: Up to 90 days after surgery
Discharge to institution
Discharge to nursing home
Measured: Up to 90 days after surgery
Worsening functional status
Increased need of assistance in performing ADL.
Measured: 1 year postoperatively.
Mortality at 30 days
Death within 30 days after surgery
Measured: 30 days after surgery
Mortality at 90 days
Death within 90 days after surgery
Measured: 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Oct 2018
- Primary completion2 Oct 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ib Jammer, PhD, MD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721471
- Sponsor's protocol ID
- 2018/315
- Status last verified
- Nov 2022
- First submitted
- 2 Oct 2018
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty
- ClinicalTrials.gov ID
- NCT03721471
- Acronym / sponsor ID
- 2018/315
- Conditions
- Frail Elderly Syndrome, Surgery--Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to investigate the effect of frailty in patients ≥ 80 years admitted for elective major abdominal surgery.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frail, non-frail | – | Other: Scoring of frailtyFrail 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. |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Patients ≥ 80 years admitted for elective major abdominal surgery at Haukeland University Hospital, Bergen, Norway.
Key inclusion criteria (3 listed)
- age 80 years or above
- elective abdominal surgery
- informed consent
Key exclusion criteria (3 listed)
- age less than 80 years
- emergency surgery
- palliative surgery ( e.g performing entero-enteroanastomosis to relieve obstruction)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scoring of frailty1. Patients will be scored by the Clinical frailty Scale 2. Patients' hand-grip-strength will be measured by a dynamometer. | Other | Frail, non-frail |
Primary outcome
Time to death
Time frame: Up to one year
Time until subject dies or up to one year after surgery
5 secondary outcomes
Postoperative complications
Time frame: Up to 90 days after surgery
Discharge to institution
Time frame: Up to 90 days after surgery
Worsening functional status
Time frame: 1 year postoperatively.
Mortality at 30 days
Time frame: 30 days after surgery
Mortality at 90 days
Time frame: 90 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No. There is no plan to make IPD available to other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ib Jammer, PhD, MD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frail Elderly Syndrome and Surgery--Complications, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to death (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.