Symptomatic Treatment of Acute Uncomplicated Diverticulitis

Not Applicable

Completed

• Conditions: Diverticulitis
• Interventions: Drug: Ibuprofen; Drug: Paracetamol

• Registration Number: NCT02219698
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

The purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-11
• Study First Submitted QC: 2014-08-18
• Study First Posted: 2014-08-19
• Status Verified: 2015-07
• Primary Completion: 2015-07
• Last Update Submitted: 2015-07-30
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Symptomatic treatment	Ibuprofen	-
Symptomatic treatment	Paracetamol	-

Primary Outcome Measures

Name	Time	Method
Complications of diverticulitis	30 days from allocation	Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Helsinki University Central Hospital; 🇫🇮 Helsinki, Finland