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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04176432
Other study ID # 2017/610
Secondary ID REK 9526
Status Completed
Phase
First received
Last updated
Start date January 1, 2015
Est. completion date January 31, 2019

Study information

Verified date November 2019
Source Haukeland University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this single-center retrospective study we wanted to investigate mortality and postoperative complications after emergency laparotomy performed in patients aged 80 years or above.


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.


Recruitment information / eligibility

Status Completed
Enrollment 106
Est. completion date January 31, 2019
Est. primary completion date December 31, 2016
Accepts healthy volunteers
Gender All
Age group 80 Years and older
Eligibility 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 Design


Intervention

Other:
No intervention
Retrospective observational study with no intervention

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Haukeland University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Deaths within 30 days after emergency laparotomy Mortality at 30 days after date of emergency laparotomy From date of emergency laparotomy until 30 days after surgery
Secondary Number of Deaths within 90 days after emergency laparotomy Mortality at 90 days after date of emergency laparotomy 90 days after emergency laparotomy
Secondary Number of Deaths within 1 year after emergency laparotomy Mortality at 1 year after date of emergency laparotomy 1 year after emergency laparotomy
Secondary Postoperative complications 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.
Secondary Level of care at discharge 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.
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