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
|Condition or disease||Intervention/treatment|
|Frail Elderly Syndrome Surgery--Complications||Other: Scoring of frailty|
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|
|Estimated Enrollment :||144 participants|
|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|
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
- Time to death [ Time Frame: Up to one year ]Time until subject dies or up to one year after surgery
- Postoperative complications [ Time Frame: Up to 90 days after surgery ]Complications as graded by the Clavien-Dindo system and defined by the EPCO-definitions.
- Discharge to institution [ Time Frame: Up to 90 days after surgery ]Discharge to nursing home
- Worsening functional status [ Time Frame: 1 year postoperatively. ]Increased need of assistance in performing ADL.
- Mortality at 30 days [ Time Frame: 30 days after surgery ]Death within 30 days after surgery
- Mortality at 90 days [ Time Frame: 90 days after surgery ]Death within 90 days after surgery
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
|Contact: Elin K Aakre, MDfirstname.lastname@example.org|
|Contact: Ib Jammer, PhD, MDemail@example.com|
|Haukeland University Hospital||Recruiting|
|Bergen, Norway, 5021|
|Contact: Elin K Aakre, MD 004755976850 firstname.lastname@example.org|
|Principal Investigator:||Ib Jammer, PhD, MD||Haukeland University Hospital|