Survival After Emergency Laparotomy in Octogenarians

Postoperative Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04176432
• Other study ID #: 2017/610
• Secondary ID: REK 9526
• Status: Completed
• 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
• 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
• 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

Related Conditions & MeSH terms

• Abdomen, Acute
• Emergencies
• Frailty
• Postoperative Complications
• Surgery--Complications

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.