Upper Gastrointestinal Perforations: a Nationwide Registry-based Study

NCT06154603 | Not Yet Recruiting

• 1 other identifier: K 2023-7938
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Abdomen

Keywords

Clinical outcomes; General surgery; Upper gastrointestinal perforation

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality up to one year after diagnosis

  One year after diagnosis

Study Arms (3)

Oesophageal perforation

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

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.

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.

Procedure: Surgical treatment type

Interventions

Surgical treatment 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; Oesophageal perforation; Small intestinal perforation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult patients with an upper gastrointestinal perforation between 2005-2023 in Sweden.

You may qualify if:

• 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

You may not qualify if:

• children

Sponsors & Collaborators

• Region Stockholm: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

Location

MeSH Terms

Conditions

Abdomen, Acute

Condition Hierarchy (Ancestors)

Abdominal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Rebecka Ahl Hulme, MD, PhD

  Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecka Ahl Hulme, MD, PhD

CONTACT

0046812373212; rebecka.ahl-hulme@regionstockholm.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: December 4, 2023
• Study Start: August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)