Open Abdomen Procedure Clinical Trial
— IROAOfficial title:
International Register of Open Abdomen
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - No age limit - Indication to Open Abdomen - Informed consent Exclusion Criteria: - Informed consent refusal - No indication to Open Abdomen |
Country | Name | City | State |
---|---|---|---|
Ireland | Letterkenny Surgery dept. Letterkenny Hospital | Letterkenny | |
Italy | Papa Giovanni XXIII hospital, | Bergamo | |
Italy | Emergency Surgery, Parma Universitary hospital | Parma | |
United States | - Emergency and Trauma Surgery dept., Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
A.O. Ospedale Papa Giovanni XXIII |
United States, Ireland, Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Indications to open abdomen | Enrollment | ||
Primary | Techniques to perform open abdomen | Enrollment | ||
Primary | Management of open abdomen | Visit 2 | ||
Primary | Definitive closure techniques | Visit 4 | ||
Secondary | Mortality rates linked to different techniques of open abdomen | During All study period | ||
Secondary | Morbidity rates linked to different techniques of open abdomen | During All study period |