Symptomatic Treatment of Acute Uncomplicated Diverticulitis

Diverticulitis Clinical Trial

Official title:

Symptomatic Treatment of Acute Uncomplicated Diverticulitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02219698
• Other study ID #: HUS-Dnro122-2014
• Status: Completed
• Phase: N/A
• First received: August 11, 2014
• Last updated: July 30, 2015
• Start date: July 2014

Study information

• Verified date: July 2015
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diverticulitis

Intervention

Drug:
• Ibuprofen

• Paracetamol

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki

Sponsors (6)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Finnish Surgical society, Governmental competitive funds (EVO), Martti I. Turunen Foundation, Mary and Georg Ehrnroot's foundation, Vatsatautien tutkimussäätiö - foundation

Country where clinical trial is conducted

Finland, 

Outcome

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