Incidence and Outcome of Acute Diverticulitis in Finland

• Sponsor: Kuopio University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05162560
• Collaborator: Tampere University Hospital (Other), Mikkeli Central Hospital (Other)
• Enrollment: 15,000
• Location: 1
• Anticipated Duration (Months): 168
• Patients Per Site Per Month: 89.3

Study Details

Study Description

Brief Summary

The incidence of acute diverticulitis (AD), conservative vs. surgical treatment and outcome of patients are studied using national registries and patient charts from two hospitals between years 2009-19.

Condition or Disease	Intervention/Treatment	Phase
Acute Diverticulitis	Other: patients with acute diverticulitis

Detailed Description

Acute diverticulitis (AD) of colon is increasing in Finland. Incidence, prevalence and mortality of AD of colon are investigated during 10-year period (2009-2019) in whole country. Epidemiological data is compared to data of acute appendicitis. Nationwide data of patients with AD are asked from Finnish Institute for Health and Welfare (THL). To compare registry-based nationwide data, patient charts from electronic database of two hospitals (Mikkeli Central Hospital and Tampere University Hospital) are reviewed from same study period. Patient characteristics, medication, treatment (conservative vs surgery), recurrence of AD and long-term outcome are recorded.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 15000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Incidence of Acute Diverticulitis in Finland: Nationwide Register Study of Epidemiology and Outcome of Treatment Between 2009-19
• Actual Study Start Date: Jan 1, 2009
• Actual Primary Completion Date: Dec 1, 2021
• Anticipated Study Completion Date: Dec 31, 2022

Outcome Measures

Primary Outcome Measures

1. Rate of annual incidence and prevalence of acute diverticulitis [January 2009-December 2019]

   how many patients with acute diverticulitis are treated in all hospitals in Finland

Secondary Outcome Measures

1. Number of patients with surgical or conservative treatment [January 2009-December 2019]

   Number of patients with conservative or surgical treatment of acute diverticulitis in two hospitals

2. Number of treatment complications and survival of patients with acute diverticulitis [January 2009-December 2019]

   outcome of patients with acute diverticulitis in two hospitals

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• all patients with acute diverticulitis (K57) in Finland and in two hospitals

Exclusion Criteria:

• other reasons for acute or chronic abdominal pain

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mikkeli Central Hospital	Mikkeli		Finland	50100

Sponsors and Collaborators

• Kuopio University Hospital
• Tampere University Hospital
• Mikkeli Central Hospital

Investigators

• Principal Investigator: Hannu EK Paajanen, MD, Eastern Univerisity of Finland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kuopio University Hospital
• ClinicalTrials.gov Identifier: NCT05162560
• Other Study ID Numbers: 5200661
• First Posted: Dec 17, 2021
• Last Update Posted: Jan 21, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diverticulitis

Study Results

No Results Posted as of Jan 21, 2022