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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05343416
Acronym
NaROA
Enrollment
300
Registered
2022-04-25
Start date
2022-01-01
Completion date
2022-12-31
Last updated
2022-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open Abdomen Technique

Brief 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.

Interventions

All patients underwent to open abdomen procedure

Sponsors

Hospital del Mar
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL

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

Design outcomes

Primary

MeasureTime frameDescription
OPEN ABDOMEN: NON-TRAUMATIC ABDOMINAL EMERGENCIEStwo yearsThe 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.

Countries

Spain

Contacts

Primary ContactAmalia Pelegrina, Ph
Apelegrina@psmar.cat+34932483000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026