NaROA STUDY: National Register of Open Abdomen (NaROA)

April 22, 2022 updated by: Amalia Pelegrina, Hospital del Mar

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.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Barcelona, Spain, 08003
        • Recruiting
        • Hospital Universitari del Mar (PSMar)
        • Contact:
          • Amalia Pelegrina, Ph
          • Phone Number: +34932483000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients underwent to open abdomen procedure

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Open abdomen procedure
All patients underwent to open abdomen procedure
Procedure: Open abdomen procedure
All patients underwent to open abdomen procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
OPEN ABDOMEN: NON-TRAUMATIC ABDOMINAL EMERGENCIES
Time Frame: two years
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.
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 23, 2021

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 25, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 22, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • Register of Open Abdom

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Open Abdomen Technique

Clinical Trials on Open abdomen procedure

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe