The purpose of 01DIVER is to evaluate efficacy and safety of a home treatment protocol for non complicated diverticulitis compared with management in the hospital. The hypothesis is that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not inferior to the conservative management in hospital in patients with acute not complicated sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively randomized to conservative antibiotic treatment either to ambulatory or to hospital treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
132
Patients are treated with the same antibiotic agent, the difference between the two arms is endovenous treatment for hospitalized patients for the first days till oral feeding. The ambulatory group starts directly with orally administered antibiotic treatment.
Hospital Universitari de la Vall d´Hebron
Barcelona, Barcelona, Spain
Hospital Universitari Bellvitge, Colorectal Unit
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari de Girona Doctor Josep Trueta
Girona, Girona, Spain
Hospital Virgen del Camino
Pamplona, Navarre, Spain
Treatment failure
Failure of the conservative treatment within 30 days after randomization which consists in one or more of the mentioned signs: persistent or increasing pain, treatment resistant fever, intestinal oclusion, necesity to drain a new intra-abdominal abscess, indication for surgery, mortality.
Time frame: 30 days
Recurrence, quality of life, costs
Recurrence of diverticulitis within 30 days; quality of life and patient satisfaction is asessed comparing management with and without admittance to the hospital and costs are calculated for the treatment in both regimens.
Time frame: 30 days
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Hospital Clinico Universitario De Valencia
Valencia, Valencia, Spain