Incidence and Outcome of Acute Diverticulitis in Finland | NCT05162560

Studies
Incidence and Outcome of Acute Diverticulitis in Finland

NCT05162560

Sponsor

Kuopio University Hospital

Status

Unknown status

Last Update Posted

Mar 7, 2024Actual

Enrollment

15,000Estimated

Phase

Not provided

Conditions

Acute Diverticulitis

Interventions

patients with acute diverticulitis

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2009Actual

Primary Completion Date

Dec 1, 2021Actual

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Oct 25, 2021

First Submission Date that Met QC Criteria

Dec 3, 2021

First Posted Date

Dec 17, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2024

Last Update Posted Date

Mar 7, 2024Actual

Name	Class
Tampere University Hospital	OTHER
Mikkeli Central Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

15,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
patients with acute diverticulitis	Other	registry and hospital charts of patients with acute diverticulitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of annual incidence and prevalence of acute diverticulitis	how many patients with acute diverticulitis are treated in all hospitals in Finland	January 2009-December 2019

Secondary Outcomes

Measure	Description	Time Frame
Number of patients with surgical or conservative treatment	Number of patients with conservative or surgical treatment of acute diverticulitis in two hospitals	January 2009-December 2019
Number of treatment complications and survival of patients with acute diverticulitis

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

other reasons for acute or chronic abdominal pain

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

patients with acute diverticulitis is whole Finland and in two study hospitals during years 2009-2019

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hannu EK Paajanen, MD	Contact	+358405263101		paajanen@surffi.fi
Tuomo Rantanen, MD	Contact	+358504028461		tuomo.rantanen@kuh.fi

Overall Officials

Name	Affiliation	Role
Hannu EK Paajanen, MD	Eastern Univerisity of Finland	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mikkeli Central Hospital	Recruiting	Mikkeli		50100	Finland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided