Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics
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|ClinicalTrials.gov Identifier: NCT02785549|
Recruitment Status : Recruiting
First Posted : May 30, 2016
Last Update Posted : May 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Diverticulitis||Drug: Ibuprofen Drug: Acetaminophen Drug: Amoxicillin/clavulanic acid||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||460 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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 Start Date :||November 2016|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||July 2020|
Experimental: Symptomatic treatment with NSAID
1 g/8 h acetaminophen alternating with 600 mg/8 h ibuprofen
1 g/8 hours
Other Name: 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
1 g/8 hours
Other Name: Paracetamol
Drug: Amoxicillin/clavulanic acid
- 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.
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02785549
|Contact: Neus Ruiz, MD||Mnruiz@tauli.cat|
|Corporació Sanitària Parc Taulí||Recruiting|
|Sabadell, Barcelona, Spain, 08208|
|Contact: NEUS RUIZ 0034937231010 ext 21490 email@example.com|
|Principal Investigator:||Laura Mora, MD PhD||Corporacion Parc Tauli|