NaROA STUDY: National Register of Open Abdomen

NCT ID: NCT05343416

Last Updated: 2022-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Open Abdomen Technique

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Open abdomen procedure

All patients underwent to open abdomen procedure

Open abdomen procedure

Intervention Type PROCEDURE

All patients underwent to open abdomen procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Open abdomen procedure

All patients underwent to open abdomen procedure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital del Mar

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amalia Pelegrina

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Universitari del Mar (PSMar)

Barcelona, , Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Amalia Pelegrina, Ph

Role: CONTACT

+34932483000

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Amalia Pelegrina, Ph

Role: primary

+34932483000

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Register of Open Abdom

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.