Acute AbdomenNCT06154603
Upper Gastrointestinal Perforations: a Nationwide Registry-based Study
An observational study of Acute Abdomen, run by Region Stockholm at 1 site in Sweden.
Trial summary
The primary aim of this project is to increase the knowledge about how perforations in the esophagus, stomach and small intestine are treated on a national level. Furthermore, secondary aims include assessment of how different treatment options and type of treating facilities relate to patient survival. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Abdomen
- What is being tested?
- Surgical treatment type
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2025to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients with an upper gastrointestinal perforation between 2005-2023 in Sweden.
Who may be able to join
- age of at least 18 years
- perforation in either oesophagus, stomach or small intestine
- treatment carried out in Sweden
- diagnosis set between January 2005 and August 2023
Who cannot join
- children
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Risk Factors for and Survival After Oesophageal, Gastric and Small Intestinal Perforations: a National Observational Registry-based Cohort Study
The primary aim of this project is to increase the knowledge about how perforations in the esophagus, stomach and small intestine are treated on a national level. Furthermore, secondary aims include assessment of how different treatment options and type of treating facilities relate to patient survival. This will be done by studying information about all adult patients with an upper GI perforation treated in Sweden during 2005-2023.
- Conditions
- Acute Abdomen
- Being tested
- Surgical treatment type
- Keywords
- Clinical outcomes, General surgery, Upper gastrointestinal perforation
- Medical subject headings
- Abdomen, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical treatment typeProcedure or surgery
This observational design will study the clinical outcome for each type of upper gastrointestinal perforation in relation to surgical or non-surgery treatment and in relation to treatment centre.
| Study group | Role | What they receive |
|---|---|---|
| Oesophageal perforation | Adult patients (at least 18 years of age) with an oesophageal perforation, treated for it at a Swedish hospital between 2005-2023. Receives: Procedure: Surgical treatment type | |
| Gastric perforation | Adult patients (at least 18 years of age) with a gastric perforation, treated for it at a Swedish hospital between 2005-2023. Receives: Procedure: Surgical treatment type | |
| Small intestinal perforation | Adult patients (at least 18 years of age) with a small intestinal perforation, treated for it at a Swedish hospital between 2005-2023. Receives: Procedure: Surgical treatment type |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality up to one year after diagnosis
Measured: One year after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study startAug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute AbdomenStudies 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Stockholm
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Rebecka Ahl Hulme, Region Stockholm
- Investigators
- Rebecka Ahl Hulme, MD, PhD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154603
- Sponsor's protocol ID
- K 2023-7938
- Status last verified
- Dec 2024
- First submitted
- 12 Oct 2023
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for and Survival After Oesophageal, Gastric and Small Intestinal Perforations: a National Observational Registry-based Cohort Study
- ClinicalTrials.gov ID
- NCT06154603
- Acronym / sponsor ID
- K 2023-7938
- Conditions
- Acute Abdomen
- Keywords
- Clinical outcomes, General surgery, Upper gastrointestinal perforation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Region StockholmOther government
- Study start
- Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 4 Dec 2023 (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.
The primary aim of this project is to increase the knowledge about how perforations in the esophagus, stomach and small intestine are treated on a national level. Furthermore, secondary aims include assessment of how different treatment options and type of treating facilities relate to patient survival. This will be done by studying information about all adult patients with an upper GI perforation treated in Sweden during 2005-2023.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oesophageal perforation | – | Procedure: Surgical treatment typeAdult patients (at least 18 years of age) with an oesophageal perforation, treated for it at a Swedish hospital between 2005-2023. |
| Gastric perforation | – | Procedure: Surgical treatment typeAdult patients (at least 18 years of age) with a gastric perforation, treated for it at a Swedish hospital between 2005-2023. |
| Small intestinal perforation | – | Procedure: Surgical treatment typeAdult patients (at least 18 years of age) with a small intestinal perforation, treated for it at a Swedish hospital between 2005-2023. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients with an upper gastrointestinal perforation between 2005-2023 in Sweden.
Key inclusion criteria (4 listed)
- age of at least 18 years
- perforation in either oesophagus, stomach or small intestine
- treatment carried out in Sweden
- diagnosis set between January 2005 and August 2023
Key exclusion criteria (1 listed)
- children
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 |
|---|---|---|
| Surgical treatment typeThis observational design will study the clinical outcome for each type of upper gastrointestinal perforation in relation to surgical or non-surgery treatment and in relation to treatment centre. | Procedure or surgery | Gastric perforation, Oesophageal perforation, Small intestinal perforation |
Primary outcome
Mortality
Time frame: One year after diagnosis
Mortality up to one year after diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Rebecka Ahl Hulme, MD, PhD principal investigator
Karolinska University Hospital
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 Acute Abdomen, run by Region Stockholm at 1 site in Sweden.
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 4 inclusion and 1 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: opening soon, as of the sponsor's last update on 5 Dec 2024. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecka Ahl Hulme, MD, PhD (0046812373212, rebecka.ahl-hulme@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: One year after diagnosis). 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 5 Dec 2024; AzTrials last refreshed its copy on 30 Oct 2026.