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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02785549
Recruitment Status : Recruiting
First Posted : May 30, 2016
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
Neus Ruiz-Edo, Corporacion Parc Tauli

Tracking Information
First Submitted Date  ICMJE May 25, 2016
First Posted Date  ICMJE May 30, 2016
Last Update Posted Date May 23, 2019
Study Start Date  ICMJE November 2016
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02785549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
  • 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
  • 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
  • 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)
  • 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.
  • Complications [ Time Frame: 3 months ]
    Description of the complications in both groups (perforation, abscess) and its treatment (percutaneous drainage, emergency surgery, broad spectrum antibiotics)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics
Official Title  ICMJE 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
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Diverticulitis
Intervention  ICMJE
  • Drug: Ibuprofen
    600 mg/8hours
  • Drug: Acetaminophen
    1 g/8 hours
    Other Name: Paracetamol
  • Drug: Amoxicillin/clavulanic acid
    875mg/125mg/8 hours
Study Arms  ICMJE
  • Experimental: Symptomatic treatment with NSAID
    1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen
    Interventions:
    • Drug: Ibuprofen
    • Drug: Acetaminophen
  • 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
    Interventions:
    • Drug: Ibuprofen
    • Drug: Acetaminophen
    • Drug: Amoxicillin/clavulanic acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 27, 2016)
460
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Neus Ruiz, MD Mnruiz@tauli.cat
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02785549
Other Study ID Numbers  ICMJE CIR-DISA-2016
2016-001596-75 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Neus Ruiz-Edo, Corporacion Parc Tauli
Study Sponsor  ICMJE Corporacion Parc Tauli
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Mora, MD PhD Corporacion Parc Tauli
PRS Account Corporacion Parc Tauli
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP