NaROA STUDY: National Register of Open Abdomen

Hospital del Mar

Status: Unknown

Conditions: Open Abdomen Technique

Treatments: Procedure: Open abdomen procedure

Study type: Observational

Funder types: Other

Identifiers

NCT05343416

Register of Open Abdom

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Indication to Open Abdomen in non-trauma patients
• Informed consent

Exclusion criteria

• Open Abdomen in trauma patients
• No indication to Open Abdomen
• Informed consent refusal

Trial design

300 participants in 1 patient group

Open abdomen procedure

Description:

All patients underwent to open abdomen procedure

Treatment:

Procedure: Open abdomen procedure