International Register of Open Abdomen

Open Abdomen Procedure Clinical Trial

— IROA  

Official title:

International Register of Open Abdomen

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02382770
• Other study ID #: 15-15
• Status: Recruiting
• Phase: N/A
• First received: February 27, 2015
• Last updated: January 26, 2017
• Start date: February 2015
• Est. completion date: December 2018

Study information

• Verified date: January 2017
• Source: A.O. Ospedale Papa Giovanni XXIII
• Contact: Federico Coccolini, MD
• Phone: 0039-0352673486
• Email: federico.coccolini[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Open Abdomen Procedure

Intervention

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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
A.O. Ospedale Papa Giovanni XXIII

Countries where clinical trial is conducted

United States,  Ireland,  Italy, 

Outcome

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