Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery

Peritonitis Clinical Trial

— PERICLASS  

Official title:

Intra-abdominal View and Inflammatory Markers in Secondary Peritonitis - Correlation to Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726932
• Other study ID #: Dnro 6/13/03/02/2016
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Peritonitis

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