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

Primary Purpose

Acute Diverticulitis

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Ibuprofen
Acetaminophen
Amoxicillin/clavulanic acid
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Diverticulitis focused on measuring Acute diverticulitis, Antibiotic, Outpatient treatment

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Corporació Sanitària Parc Taulí

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Symptomatic treatment with NSAID

Antibiotic+symptomatic treatment with NSAID

Arm Description

1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen

875/125mg /8h amoxicillin/clavulanic acid and symptomatic treatment with 1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen

Outcomes

Primary Outcome Measures

Readmission ratio
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.

Secondary Outcome Measures

Reconsultation ratio
The analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation
Reason for reconsultation
The analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation
Reason for readmission
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
The analysis of the differences between groups, in case there are, in relation to pain control (analogic visual scale), during follow-up.
Complications
Description of the complications in both groups (perforation, abscess) and its treatment (percutaneous drainage, emergency surgery, broad spectrum antibiotics)

Full Information

First Posted
May 25, 2016
Last Updated
May 13, 2020
Sponsor
Corporacion Parc Tauli
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1. Study Identification

Unique Protocol Identification Number
NCT02785549
Brief Title
Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 12, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Diverticulitis
Keywords
Acute diverticulitis, Antibiotic, Outpatient treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
480 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Symptomatic treatment with NSAID
Arm Type
Experimental
Arm Description
1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen
Arm Title
Antibiotic+symptomatic treatment with NSAID
Arm Type
Active Comparator
Arm Description
875/125mg /8h amoxicillin/clavulanic acid and symptomatic treatment with 1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen
Intervention Type
Drug
Intervention Name(s)
Ibuprofen
Intervention Description
600 mg/8hours
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Paracetamol
Intervention Description
1 g/8 hours
Intervention Type
Drug
Intervention Name(s)
Amoxicillin/clavulanic acid
Intervention Description
875mg/125mg/8 hours
Primary Outcome Measure Information:
Title
Readmission ratio
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Reconsultation ratio
Description
The analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation
Time Frame
3 months
Title
Reason for reconsultation
Description
The analysis of the differences between groups, in case there are, in relation to number and reason for reconsultation
Time Frame
3 months
Title
Reason for readmission
Description
The analysis of the differences between groups, in case there are, in relation to reason for readmission (bad symptoms control, radiologic progression, analysis worsening)
Time Frame
3 months
Title
Pain control
Description
The analysis of the differences between groups, in case there are, in relation to pain control (analogic visual scale), during follow-up.
Time Frame
48 hours, 7 days, 1 month, 3 months
Title
Complications
Description
Description of the complications in both groups (perforation, abscess) and its treatment (percutaneous drainage, emergency surgery, broad spectrum antibiotics)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neus Ruiz, MD
Organizational Affiliation
Corporacion Parc Tauli
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Mora, MD PhD
Organizational Affiliation
Corporacion Parc Tauli
Official's Role
Principal Investigator
Facility Information:
Facility Name
Corporació Sanitària Parc Taulí
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics

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