Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics

• Status: Completed
• Trial end date: 2020-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corporacion Parc Tauli
• Treatments: Acetaminophen; Amoxicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Clavulanic Acid; Clavulanic Acids; Ibuprofen

Criteria

Inclusion Criteria:

• Patient's written informed consent. Adequate cognitive capacity.

• Adequate family support

• No acute diverticulitis episode in the last 3 months

• mNeff 0 acute diverticulitis (abdominal computed tomography scan)

• No antibiotic treatment in the last 2 weeks

• Immunocompetence*

• No significant comorbidities**

• Good oral tolerance

• Good symptom control

• Maximum one of the following SIRS criteria (* T>38 ºC or <36ºC, L>12,000 or <4000/uL, HR>90 bpm, RR<20 rpm) or CRP>15 mg/dL

Exclusion Criteria:

• Women in pregnancy or breastfeeding

• Age <18 years or > 80 years.

• Absence of the patient's written informed consent. Inadequate cognitive capacity.

• Inadequate family support

• Acute diverticulitis episode in the last 3 months

• Moderate acute diverticulitis (mNeff grade I or upper)

• Antibiotic treatment in the last 2 weeks

• Inflammatory bowel disease

• Immunodepression*

• Presence of significant comorbidities**

• Bad oral tolerance

• Poor symptom control

• More than one of the following SIRS criteria (* T>38 ºC or <36ºC, L>12,000 or <4000/uL, HR>90 bpm, RR<20 rpm) or CRP>15 mg/dL

(*) Immunocompetence is the absence and immunodepression is the presence of any of the following: active neoplastic disease/hematologic malignancy/HIV with low CD4+ count/long-term corticosteroid treatment/immunosuppressant therapy/transplant/splenectomy/genetic immunodeficiency.

(**) We consider significant comorbidities any of the following: poorly controlled diabetes mellitus (HbA1>7mg/dl), cardiologic event in the last 3 months, decompensation of hepatopathy in the last 3 months, renal chronic insufficiency in dialysis programme.