NCT05343416

NaROA STUDY: National Register of Open Abdomen

NaROA STUDY: OBSERVATIONAL, PROSPECTIVE, MULTICENTRIC, NATIONAL OPEN ABDOMEN REGISTRY FOR THE ANALYSIS OF INDICATIONS AND PRONOTIC FACTORS OF MORBI-MORTALITY IN PATIENTS UNDERGOING EMERGENCY SURGERY BY GENERAL SURGERY.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Hospital del Mar · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: —

Summary

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

Detailed 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.

Conditions

• Open Abdomen Technique

Interventions

Type	Name	Description
PROCEDURE	Open abdomen procedure	All patients underwent to open abdomen procedure

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2022-04-25
• Last updated: 2022-04-25

Locations

1 site across 1 country: Spain