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NCT06154603 Clinical Trial

Upper Gastrointestinal Perforations: a Nationwide Registry-based Study

Acute Abdomen Clinical Trial

Official title:
Risk Factors for and Survival After Oesophageal, Gastric and Small Intestinal Perforations: a National Observational Registry-based Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT06154603
Other study ID # K 2023-7938
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date November 23, 2023
Est. completion date April 2024

Study information
Verified date November 2023
Source Region Stockholm
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. This will be done by studying information about all adult patients with an upper GI perforation treated in Sweden during 2005-2023.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - children

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Surgical treatment type
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.

Locations
Country Name City State
Sweden Karolinska University Hospital Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mortality Mortality up to one year after diagnosis One year after diagnosis
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