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Clinical Trial Summary

National Register of Open Abdomen Open Abdomen Procedure (Observational and Prospective Study)


Clinical Trial Description

The open abdomen technique has widely been proven useful in the treatment of traumatic patients, but its indication in non-traumatic patients with catastrophic abdomen (peritonitis, ischaemia, pancreatitis) generates controversy. Its heterogeneous implementation is based on insufficient evidence and originated in health systems very different from ours. Its low prevalence imposes the need for a multicentre study. AIMS : Establish a national, prospective, multi-centre national registry of non traumatic patients with open abdominal indication whether or not they undergo damage control surgery and open abdomen for: 1. Describe in real time the indications, surgical technique, materials, time, risk factors, definitive closure, reinterventions and complications according to the Clavien-Dindo classification and mortality. 2. Compare the results of the application or non-application of the open abdomen in non-traumatic patients between the different participating centers. 3. Set the limits of the open abdomen in non-traumatic patients indication. ;


Study Design


NCT number NCT05343416
Study type Observational [Patient Registry]
Source Hospital del Mar
Contact Amalia Pelegrina, Ph
Phone +34932483000
Email Apelegrina@psmar.cat
Status Recruiting
Phase
Start date January 1, 2022
Completion date December 31, 2022