- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04176432
Survival After Emergency Laparotomy in Octogenarians
Mortality and Complications After Emergency Laparotomy in Patients 80 Years Old or Older
Study Overview
Status
Intervention / Treatment
Detailed Description
Methods:
During 2015-2016 106 patients aged 80 years or above underwent emergency laparotomy at Haukeland University Hospital.
Primary outcome was mortality at 30 days. Secondary outcomes were mortality at 90 days, 1 year, postoperative complications and level of care at discharge.
The Medical records were reviewed in detail and mortality and postoperative morbidity were registered. Post-operative complications were defined according to the European Perioperative Clinical Outcome (EPCO) definitions and included if they were Clavien Dindo grade 2 or above.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- emergency laparotomy in patients 80 years or above
Exclusion Criteria:
- palliative surgery
- abdominal surgery other than gastrointestinal
- abdominal surgery without midline incision
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Deaths within 30 days after emergency laparotomy
Time Frame: From date of emergency laparotomy until 30 days after surgery
|
Mortality at 30 days after date of emergency laparotomy
|
From date of emergency laparotomy until 30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Deaths within 90 days after emergency laparotomy
Time Frame: 90 days after emergency laparotomy
|
Mortality at 90 days after date of emergency laparotomy
|
90 days after emergency laparotomy
|
Number of Deaths within 1 year after emergency laparotomy
Time Frame: 1 year after emergency laparotomy
|
Mortality at 1 year after date of emergency laparotomy
|
1 year after emergency laparotomy
|
Postoperative complications
Time Frame: Postoperative complications registered in medical records from date of emergency laparotomy until death in hospital or discharge from hospital, whichever came first.
|
Number of patients having a postoperative complication as defined by the European Perioperative Clinical Outcome Definitions (EPCO) will be reported. The EPCO definitions state universal description of various common postoperative complications, like f.ex pulmonary complications, major adverse cardiac events, urinary tract infections and so on. This is a way of securing a universal approach to postoperative complications. We will grade complications according to the Clavien Dindo classification. According to this classification postoperative complications are graded from 1 to 5, where 1 indicates least severity of complication and 5 indicating worst severity. We will report number of patients having complications from grade 2 to grade 5. |
Postoperative complications registered in medical records from date of emergency laparotomy until death in hospital or discharge from hospital, whichever came first.
|
Level of care at discharge
Time Frame: Up to 90 days from date of emergency laparotomy.
|
From the medical records will be retreived information regarding dependency in activities of daily living (ADL) at discharge.
Specifically will be measured number of patients discharged to own home, and number of patients discharged to nursing home facility.
Also will be measured number of patients transferred to other hospital.
|
Up to 90 days from date of emergency laparotomy.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/610
- REK 9526 (OTHER: Regional Ethics Committe)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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