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

May 13, 2020 updated by: Neus Ruiz-Edo, Corporacion Parc Tauli

Multicentre Controlled, Randomized Clinical Trial to Compare the Efficacy and Safety of Ambulatory Treatment of Mild Acute Diverticulitis Without Antibiotics With the Standard Treatment With Antibiotics

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

480

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Symptomatic treatment with NSAID
1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen
Drug: Ibuprofen
600 mg/8hours
Drug: Acetaminophen
1 g/8 hours
Other Names:
  • Paracetamol
Active Comparator: Antibiotic+symptomatic treatment with NSAID
875/125mg /8h amoxicillin/clavulanic acid and symptomatic treatment with 1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen
Drug: Ibuprofen
600 mg/8hours
Drug: Acetaminophen
1 g/8 hours
Other Names:
  • Paracetamol
Drug: Amoxicillin/clavulanic acid
875mg/125mg/8 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Readmission ratio
Time Frame: 3 months
Primary outcome is to determine if, in mild acute diverticulitis, the treatment without antibiotic is not-inferior to the traditional treatment with antibiotic considering readmission ratio.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reconsultation ratio
Time Frame: 3 months
The analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation
3 months
Reason for reconsultation
Time Frame: 3 months
The analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation
3 months
Reason for readmission
Time Frame: 3 months
The analysis of the differences between groups, in case there are, in relation to reason for readmission (bad symptoms control, radiologic progression, analysis worsening)
3 months
Pain control
Time Frame: 48 hours, 7 days, 1 month, 3 months
The analysis of the differences between groups, in case there are, in relation to pain control (analogic visual scale), during follow-up.
48 hours, 7 days, 1 month, 3 months
Complications
Time Frame: 3 months
Description of the complications in both groups (perforation, abscess) and its treatment (percutaneous drainage, emergency surgery, broad spectrum antibiotics)
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Neus Ruiz, MD, Corporacion Parc Tauli
  • Principal Investigator: Laura Mora, MD PhD, Corporacion Parc Tauli

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

January 12, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

May 25, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

May 30, 2016

Study Record Updates

Last Update Posted (Actual)

May 14, 2020

Last Update Submitted That Met QC Criteria

May 13, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIR-DISA-2016
  • 2016-001596-75 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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