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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02726932
Other study ID # Dnro 6/13/03/02/2016
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 30, 2016
Est. completion date March 30, 2018

Study information

Verified date January 2019
Source Helsinki University Central Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to analyze the correlation between intra-abdominal view and patient recovery in secondary peritonitis, and to create a new classification based on these results. Additionally, a variety of inflammatory markers from blood samples will be collected in order to analyze their correlation with patient outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 283
Est. completion date March 30, 2018
Est. primary completion date March 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- adult patients > 18 years old

- operated for complicated intra-abdominal infection

Exclusion Criteria:

- another diagnosis requiring ICU level care at the same time

- acute pancreatitis

- acute mesenteric ischaemia due to occlusion in superior mesenteric artery or vein

- peritonitis due to timely diagnosed trauma

- missing informed consent or inability to understand it

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No intervention, merely observational


Locations

Country Name City State
Finland Helsinki University Central Hospital Helsinki

Sponsors (1)

Lead Sponsor Collaborator
Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality Death within 90 days of primary operation for diffuse peritonitis 90 days
Primary ICU admission Intensive Care Unit admission and length of ICU treatment 90 days
Primary Length of hospitalization Days in hospital postoperatively 90 days
Primary Reoperations Reoperations needed postoperatively 90 days
Primary Complications Postoperative complications according to Clavien-Dindo classification 90 days
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