Abstract
BackgroundConservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, however, uncertain whether patients with acute diverticulitis indeed benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts' opinion. Adverse effects of the use of antibiotics are well known, including allergic reactions, development of bacterial resistance to antibiotics and other side-effects.MethodsA randomized multicenter pragmatic clinical trial comparing two treatment strategies for uncomplicated acute diverticulitis. I) A conservative strategy with antibiotics: hospital admission, supportive measures and at least 48 hours of intravenous antibiotics which subsequently are switched to oral, if tolerated (for a total duration of antibiotic treatment of 10 days). II) A liberal strategy without antibiotics: admission only if needed on clinical grounds, supportive measures only. Patients are eligible for inclusion if they have a diagnosis of acute uncomplicated diverticulitis as demonstrated by radiological imaging. Only patients with stages 1a and 1b according to Hinchey's classification or "mild" diverticulitis according to the Ambrosetti criteria are included. The primary endpoint is time-to-full recovery within a 6-month follow-up period. Full recovery is defined as being discharged from the hospital, with a return to pre-illness activities, and VAS score below 4 without the use of daily pain medication. Secondary endpoints are proportion of patients who develop complicated diverticulitis requiring surgery or non-surgical intervention, morbidity, costs, health-related quality of life, readmission rate and acute diverticulitis recurrence rate. In a non-inferiority design 264 patients are needed in each study arm to detect a difference in time-to-full recovery of 5 days or more with a power of 85% and a confidence level of 95%. With an estimated one percent of patients lost to follow up, a total of 533 patients will be included.ConclusionA clinically relevant difference of more than 5 days in time-to-full recovery between the two treatment strategies is not expected. The liberal strategy without antibiotics and without the strict requirement for hospital admission is anticipated to be more a more cost-effective approach.Trial registrationTrial registration number: NCT01111253
Highlights
Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy
Prevalence of diverticular disease increases with age, from less than 10% in people younger than age 40 to 50-66% in octogenarians, with similar frequency in men and women
All and all about 5% of patients with diverticulosis will undergo an episode of complicated diverticulitis
Summary
Conservative treatment of uncomplicated or mild diverticulitis usually includes antibiotic therapy. It is, uncertain whether patients with acute diverticulitis benefit from antibiotics. In most guidelines issued by professional organizations antibiotics are considered mandatory in the treatment of mild diverticulitis. This advice lacks evidence and is merely based on experts’ opinion. Three quarters of patients with diverticulosis remain asymptomatic throughout their lifetime. Of the 25% of patients who develop symptomatic diverticular disease, approximately three quarters develop diverticulitis [1,2]. Of all patients with diverticulitis, 75% have mild acute disease only and 25% develop complicated disease [3]. All and all about 5% of patients with diverticulosis will undergo an episode of complicated diverticulitis
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