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Trial record 18 of 1046 for:    scale | Norway

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

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ClinicalTrials.gov Identifier: NCT03721471
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Haukeland University Hospital

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

Condition or disease Intervention/treatment
Frail Elderly Syndrome Surgery--Complications 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.


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Study Type : Observational
Estimated Enrollment : 144 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Outcome of Very Old Patients Admitted for Elective Major Surgery, the Effect of Frailty
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022

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




Primary Outcome Measures :
  1. Time to death [ Time Frame: Up to one year ]
    Time until subject dies or up to one year after surgery


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   80 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients ≥ 80 years admitted for elective major abdominal surgery at Haukeland University Hospital, Bergen, Norway.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721471


Contacts
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Contact: Elin K Aakre, MD 004755976850 elin.kismul.aakre@helse-bergen.no
Contact: Ib Jammer, PhD, MD 004755976850 ib.jammer@helse-bergen.no

Locations
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Norway
Haukeland University Hospital Recruiting
Bergen, Norway, 5021
Contact: Elin K Aakre, MD    004755976850    elin.kismul.aakre@helse-bergen.no   
Sponsors and Collaborators
Haukeland University Hospital
Investigators
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Principal Investigator: Ib Jammer, PhD, MD Haukeland University Hospital

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Responsible Party: Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03721471     History of Changes
Other Study ID Numbers: 2018/315
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Frailty
Pathologic Processes