Symptomatic Treatment of Acute Uncomplicated Diverticulitis

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2015
• Main ID: NCT02219698
• Date of registration: 11/08/2014
• Prospective Registration: No
• Primary sponsor: Helsinki University Central Hospital
• Public title: Symptomatic Treatment of Acute Uncomplicated Diverticulitis
• Scientific title: Symptomatic Treatment of Acute Uncomplicated Diverticulitis
• Date of first enrolment: July 2014
• Target sample size: 158
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02219698
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

Finland

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diverticulitis

Intervention(s)

Drug: Ibuprofen

Drug: Paracetamol

Primary Outcome(s)

Complications of diverticulitis [Time Frame: 30 days from allocation]

Secondary Outcome(s)

Need for emergency surgery for diverticulitis on another admission [Time Frame: 10 years]

Rate of re-admissions [Time Frame: 30 days from discharge]

Late complication of diverticulitis [Time Frame: 10 years]

Recurrence of diverticulitis [Time Frame: 10 years]

Stoma rate [Time Frame: 10 years]

Commencement of antimicrobial drug [Time Frame: For the duration of hospital stay, an expected average of 2 days]

Length of hospital stay (days) [Time Frame: At the end of the hospital stay, an expected average of 2 days]

Mortality [Time Frame: 30 days from allocation]

Need for elective sigmoid resection [Time Frame: 10 years]

Secondary ID(s)

HUS-Dnro122-2014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Vatsatautien tutkimussäätiö - foundation

Mary and Georg Ehrnroot's foundation

Finnish Surgical society

Governmental competitive funds (EVO)

Martti I. Turunen Foundation