NCT04176432

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 25, 2019

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

2 years

First QC Date

September 27, 2019

Last Update Submit

November 21, 2019

Conditions

Abdomen, AcuteSurgery--ComplicationsPostoperative ComplicationsFrailty

Keywords

Emergency surgeryFrailtyElderlyPostoperative complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Number of Deaths within 90 days after emergency laparotomy

    90 days after emergency laparotomy

  • Number of Deaths within 1 year after emergency laparotomy

    1 year after emergency laparotomy

  • Postoperative complications

    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

    Up to 90 days from date of emergency laparotomy.

Interventions

No interventionOTHER

Retrospective observational study with no intervention

Eligibility Criteria

Age80 Years+
Sexall
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients admitted to Haukeland University Hospital during 2015-2016

You may qualify if:

  • emergency laparotomy in patients 80 years or above

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Abdomen, AcutePostoperative ComplicationsFrailty

Condition Hierarchy (Ancestors)

Abdominal PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestivePathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2019

First Posted

November 25, 2019

Study Start

January 1, 2015

Primary Completion

December 31, 2016

Study Completion

January 31, 2019

Last Updated

November 25, 2019

Record last verified: 2019-11