Symptomatic Treatment of Acute Uncomplicated Diverticulitis

July 30, 2015 updated by: Ville Sallinen, Helsinki University Central Hospital
The purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

158

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Computed tomography-diagnosed acute uncomplicated* diverticulitis

    • No abscess, fistula, obstruction and distant intra- or retroperitoneal air. Pericolic air allowed.

Exclusion Criteria:

  • Already commenced antimicrobial medication
  • Immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive medication, chemotherapy, chronic liver disease)
  • Suspicion of generalized peritonitis
  • Organ dysfunction
  • Another infection requiring antimicrobial medication
  • Pregnancy
  • Age < 18 years or > 90 years
  • Missing written consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symptomatic treatment
Drug: Paracetamol
Drug: Ibuprofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of diverticulitis
Time Frame: 30 days from allocation
Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)
30 days from allocation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of hospital stay (days)
Time Frame: At the end of the hospital stay, an expected average of 2 days
At the end of the hospital stay, an expected average of 2 days
Rate of re-admissions
Time Frame: 30 days from discharge
Number patients re-admitted to hospital
30 days from discharge
Recurrence of diverticulitis
Time Frame: 10 years
Number of recurrent diverticulitis within follow-up
10 years
Mortality
Time Frame: 30 days from allocation
Number of patients deceased
30 days from allocation
Need for elective sigmoid resection
Time Frame: 10 years
Number of patients that have undergone elective sigmoid resection
10 years
Need for emergency surgery for diverticulitis on another admission
Time Frame: 10 years
Number of patients requiring emergency surgery for diverticulitis on another admission
10 years
Commencement of antimicrobial drug
Time Frame: For the duration of hospital stay, an expected average of 2 days
Number of patients that have received antimicrobial drugs
For the duration of hospital stay, an expected average of 2 days
Late complication of diverticulitis
Time Frame: 10 years
Number of patients who develop late complications of diverticulitis e.g. fistula, stricture
10 years
Stoma rate
Time Frame: 10 years
Number of patients who receive a stoma
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Helsinki University Central Hospital

Collaborators

Vatsatautien tutkimussäätiö - foundation
Mary and Georg Ehrnroot's foundation
Finnish Surgical society
Martti I. Turunen Foundation
Governmental competitive funds (EVO)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

August 11, 2014

First Submitted That Met QC Criteria

August 18, 2014

First Posted (Estimate)

August 19, 2014

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUS-Dnro122-2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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