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Upper Gastrointestinal Perforations: a Nationwide Registry-based Study

NCT ID: NCT06154603

Last Updated: 2024-12-05

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

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-31

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Abdomen

Keywords

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Clinical outcomes General surgery Upper gastrointestinal perforation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Oesophageal perforation

Adult patients (at least 18 years of age) with an oesophageal perforation, treated for it at a Swedish hospital between 2005-2023.

Surgical treatment type

Intervention Type PROCEDURE

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.

Gastric perforation

Adult patients (at least 18 years of age) with a gastric perforation, treated for it at a Swedish hospital between 2005-2023.

Surgical treatment type

Intervention Type PROCEDURE

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.

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.

Surgical treatment type

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role lead

Responsible Party

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Rebecka Ahl Hulme

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rebecka Ahl Hulme, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska University Hospital

Locations

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Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Central Contacts

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Rebecka Ahl Hulme, MD, PhD

Role: CONTACT

Phone: 0046812373212

Email: [email protected]

Other Identifiers

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K 2023-7938

Identifier Type: -

Identifier Source: org_study_id