Survival After Emergency Laparotomy in Octogenarians

November 21, 2019 updated by: Haukeland University Hospital

Mortality and Complications After Emergency Laparotomy in Patients 80 Years Old or Older

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.

Study Overview

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

Observational

Enrollment (Actual)

106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

80 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients admitted to Haukeland University Hospital during 2015-2016

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2015

Primary Completion (ACTUAL)

December 31, 2016

Study Completion (ACTUAL)

January 31, 2019

Study Registration Dates

First Submitted

September 27, 2019

First Submitted That Met QC Criteria

November 21, 2019

First Posted (ACTUAL)

November 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

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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