Open Abdomen TechniqueNaROANCT05343416
NaROA STUDY: National Register of Open Abdomen
An observational study of Open Abdomen Technique, run by Hospital del Mar at 1 site in Spain.
Trial summary
National Register of Open Abdomen Open Abdomen Procedure (Observational and Prospective Study) Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Open Abdomen Technique
- What is being tested?
- Open abdomen procedure
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 31 Dec 2022
- How long will I take part?
- 9 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Study population: All patients underwent to open abdomen procedure
Who may be able to join
- Indication to Open Abdomen in non-trauma patients
- Informed consent
Who cannot join
- Open Abdomen in trauma patients
- No indication to Open Abdomen
- Informed consent refusal
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari del Mar (PSMar)
Barcelona, 08003
Amalia Pelegrina, Ph, +34932483000
About this study
Official title: 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)
Read the 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:
- 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.
- Compare the results of the application or non-application of the open abdomen in non-traumatic patients between the different participating centers.
- Set the limits of the open abdomen in non-traumatic patients indication.
- Conditions
- Open Abdomen Technique
- Being tested
- Open abdomen procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open abdomen procedureProcedure or surgery
All patients underwent to open abdomen procedure
| Study group | Role | What they receive |
|---|---|---|
| Open abdomen procedure | All patients underwent to open abdomen procedure Receives: Procedure: Open abdomen procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
OPEN ABDOMEN: NON-TRAUMATIC ABDOMINAL EMERGENCIES
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.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Abdomen TechniqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 9 Months
Sponsor and investigators
- Lead sponsor
- Hospital del Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amalia Pelegrina, Hospital del Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343416
- Sponsor's protocol ID
- Register of Open Abdom
- Acronym
- NaROA
- Status last verified
- Jan 2022
- First submitted
- 23 Feb 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05343416
- Acronym / sponsor ID
- NaROA / Register of Open Abdom
- Conditions
- Open Abdomen Technique
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospital del MarUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 25 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Compare the results of the application or non-application of the open abdomen in non-traumatic patients between the different participating centers.
- Set the limits of the open abdomen in non-traumatic patients indication.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 9 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open abdomen procedure | – | Procedure: Open abdomen procedureAll patients underwent to open abdomen procedure |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- All patients underwent to open abdomen procedure
Key inclusion criteria (2 listed)
- Indication to Open Abdomen in non-trauma patients
- Informed consent
Key exclusion criteria (3 listed)
- Open Abdomen in trauma patients
- No indication to Open Abdomen
- Informed consent refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open abdomen procedureAll patients underwent to open abdomen procedure | Procedure or surgery | Open abdomen procedure |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Abdomen Technique, run by Hospital del Mar at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amalia Pelegrina, Ph (+34932483000, Apelegrina@psmar.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OPEN ABDOMEN: NON-TRAUMATIC ABDOMINAL EMERGENCIES (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.