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Completed

NCT Number: NCT04176432

Survival After Emergency Laparotomy in Octogenarians

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.

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Key information

Conditions

Abdomen, Acute Abdominal Pain Frailty Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Signs and Symptoms, Digestive Surgery--Complications

Age range

80 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • emergency laparotomy in patients 80 years or above

Exclusion criteria

  • palliative surgery
  • abdominal surgery other than gastrointestinal
  • abdominal surgery without midline incision

Treatment and study plan

No intervention

Other

Retrospective observational study with no intervention

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2019
First posted
Nov 25, 2019
Registry last updated
Nov 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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