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

January 15, 2019 updated by: Matti Tolonen, Helsinki University Central Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

283

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adult patients operated for complicated intra-abdominal infection in a single university hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Investigators

  • Study Chair: Panu Mentula, M.D., Ph.D., Helsinki University Central Hospital, Abdominal Center, Gastrointestinal Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2016

Primary Completion (Actual)

March 30, 2018

Study Completion (Actual)

March 30, 2018

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Actual)

January 16, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dnro 6/13/03/02/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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