IROA: International Register of Open Abdomen

Sponsor

A.O. Ospedale Papa Giovanni XXIII (Other)

Overall Status

Unknown status

CT.gov ID

NCT02382770

Collaborator

(none)

300

Enrollment

Locations

Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Open Abdomen Procedure	Procedure: Open abdomen procedure

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

International Register of Open Abdomen

Study Start Date :

Feb 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Indications to open abdomen [Enrollment]
Techniques to perform open abdomen [Enrollment]
Management of open abdomen [Visit 2]
Definitive closure techniques [Visit 4]

Secondary Outcome Measures

Mortality rates linked to different techniques of open abdomen [During All study period]
Morbidity rates linked to different techniques of open abdomen [During All study period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

No age limit
Indication to Open Abdomen
Informed consent

Exclusion Criteria:

Informed consent refusal
No indication to Open Abdomen

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	- Emergency and Trauma Surgery dept., Virginia Commonwealth University	Richmond	Virginia	United States
2	Letterkenny Surgery dept. Letterkenny Hospital	Letterkenny		Ireland
3	Papa Giovanni XXIII hospital,	Bergamo		Italy	24128
4	Emergency Surgery, Parma Universitary hospital	Parma		Italy

Sponsors and Collaborators

A.O. Ospedale Papa Giovanni XXIII

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Federico Coccolini, MD, M.D., A.O. Ospedale Papa Giovanni XXIII

ClinicalTrials.gov Identifier:

NCT02382770

Other Study ID Numbers:

15-15

First Posted:

Mar 9, 2015

Last Update Posted:

Jan 27, 2017

Last Verified:

Jan 1, 2017

Study Results

No Results Posted as of Jan 27, 2017