International Register of Open Abdomen (IROA)

January 26, 2017 updated by: Federico Coccolini, MD, A.O. Ospedale Papa Giovanni XXIII
To evaluate the different indications to Open Abdomen, the different techniques used to perform it, it's management, it's definitive closure and mortality rates linked to the different variables. Moreover to evaluate the 1 month and 1 year follow up in patients underwent to Open Abdomen.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

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

  • Ireland
      • Letterkenny, Ireland
        • Recruiting
        • Letterkenny Surgery dept. Letterkenny Hospital
        • Contact:
  • Italy
      • Bergamo, Italy, 24128
      • Parma, Italy
        • Recruiting
        • Emergency Surgery, Parma Universitary hospital
        • Contact:
  • United States
    • Virginia
      • Richmond, Virginia, United States
        • Recruiting
        • - Emergency and Trauma Surgery dept., Virginia Commonwealth University
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients who may require to be undergone to open abdomen procedure

Description

Inclusion Criteria:

  • No age limit
  • Indication to Open Abdomen
  • Informed consent

Exclusion Criteria:

  • Informed consent refusal
  • No indication to Open Abdomen

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open Abdomen patients
All patients underwent to open abdomen procedure
Procedure: Open abdomen procedure
Patients who may need at the end of surgical procedure will be left with open abdomen dressed with different devices or dressing according to the institutional indications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Indications to open abdomen
Time Frame: Enrollment
Enrollment
Techniques to perform open abdomen
Time Frame: Enrollment
Enrollment
Management of open abdomen
Time Frame: Visit 2
Visit 2
Definitive closure techniques
Time Frame: Visit 4
Visit 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Mortality rates linked to different techniques of open abdomen
Time Frame: During All study period
During All study period
Morbidity rates linked to different techniques of open abdomen
Time Frame: During All study period
During All study period

Collaborators and Investigators

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

Sponsor

A.O. Ospedale Papa Giovanni XXIII

Investigators

  • Principal Investigator: Federico Coccolini, MD, Papa Giovanni XXIII, P.zza OMS 1, 24128 Bergamo, Italy

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

February 1, 2015

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (Estimate)

March 9, 2015

Study Record Updates

Last Update Posted (Estimate)

January 27, 2017

Last Update Submitted That Met QC Criteria

January 26, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 15-15

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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