Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics
Condition: Acute Diverticulitis
MeSH terms: Diverticulitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with mild acute diverticulitis (modified Neff 0 grade), following the inclusion
      criteria and giving informed consent, will be included in the study protocol and will be
      randomly assigned to one of the treatment arms: symptomatic treatment with NSAID plus
      antibiotic vs symptomatic treatment with NSAID only. They will be followed-up at 48 hours, 7
      days, 30 days and 3 months from the onset of the episode.
    

Detailed description: 
      In the last years, traditional pathologic mechanisms of acute diverticulitis are being
      questioned and replaced by more scientifically grounded hypotheses that strongly postulate an
      inflammatory origin. Local pro-inflammatory cytokines, microbiota shifts, disturbed
      neurological intestinal signalling due to alterations in colonic neuropeptides and abnormal
      colonic motility are all being proposed as potential etiologic factors. Recent publications,
      therefore, call into question the benefits of antibiotic treatment or episodes of acute
      diverticulitis, especially for mild episodes. Furthermore, recent international guidelines
      endorse this stance in their recommendations. Moreover, recent studies provide evidence
      regarding the security of treating patients with mild acute diverticulitis as outpatients.

      The investigators think that outpatient treatment without antibiotic for mild acute
      diverticulitis is not-inferior to traditional treatment with antibiotic, measuring the
      efficacy with readmission ratio. For this reason we have designed a multicentric, randomised,
      prospective study.

      All patients seen in the emergency department with clinical signs of acute diverticulitis
      (left iliac fossa abdominal pain, peritoneal irritation signs and/or leucocytosis) will
      undergo an abdominal computed tomography to confirm the diagnosis and grade the disease
      according to severity using the modified Neff (mNeff) classification. Those with mild acute
      diverticulitis (grade 0), following the inclusion criteria and giving informed consent, will
      be included in the study protocol and will be randomly assigned to one of the treatment arms:
      symptomatic treatment with NSAID plus antibiotic vs symptomatic treatment with NSAID only.
      They will be followed-up at 48 hours, 7 days, 30 days and 3 months from the onset of the
      episode.

      Primary goal is to determine if, in mild acute diverticulitis, the treatment without
      antibiotic is not-inferior to the traditional treatment with antibiotic considering
      readmission ratio.

      Secondary goals include the analysis of the differences between groups, in case there are, in
      relation to number and reason for reconsultation, reason for readmission (bad symptoms
      control, radiologic progression, analysis worsening), pain control (analogic visual scale),
      recuperation after the acute episode, complication rate and their treatment.
    

Intervention name(s): Ibuprofen; Acetaminophen; Amoxicillin/clavulanic acid
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 600 mg/8hours; 1 g/8 hours; 875mg/125mg/8 hours
Other intervention name(s): Paracetamol
Intervention MeSH terms: Acetaminophen; Amoxicillin; Clavulanic Acids; Clavulanic Acid; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Acute diverticulitis; Antibiotic; Outpatient treatment