Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon

Study Overview
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Brief Summary
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The aim of the present study was to evaluate whether antibiotics is mandatory for the treatment of acute uncomplicated right-sided diverticulitis. The hypothesis is that patients having acute uncomplicated diverticulitis at right-sided colon will be recovered without antibiotics.

Detailed Description
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All patients in the study were randomly allocated to one of the following two treatment groups; no-antibiotics group or antibiotics group. Patients of no-antibiotics group were admitted to the ward and administered intravenous fluid and bowel rest at least up to 5 days until clinical symptom and sign were stabilized. And then the patient discharge until oral intake was tolerated. In antibiotics group, the treatment was initiated with an intravenous combination of a third generation cephalosporin or quinolone and metronidazole until oral intake was tolerated. Oral antibiotics such as cefpodoxime together with metronidazole were initiated subsequently on the ward. The total duration of antibiotic treatment was an expected average 10days. Patients in both group were re-visited outpatient clinic after an expected average 7 days for check-up of serology test (including complete blood count and C-reactive protein), and after an expected average 6 weeks for CT. If the patients did not re-visit outpatient clinic, we checked the call.

Official Title
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Prospective Randomized Clinical Trial for the Management of Uncomplicated Diverticulitis in Right Colon; Non-antibiotics Versus Antibiotics

Conditions
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Simple Diverticular Disease

Intervention / Treatment
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* Drug: Cephalosporin + Metronidazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Right-sided colonic diverticulitis Uncomplicated diverticulitis Exclusion Criteria: Pregnancy Refuse to investigation Immunosuppressive therapy or immunologic incompetence Colonic diverticulitis except right-sided diverticulitis Complicated diverticulitis Disorder of psychology or cognition Allergic reaction to antibiotics being used in the study (3rd generation cephalosporin, quinolone, metronidazole)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cephalosporin + Metronidazole<br>intravenous antibiotics injection (3rd generation cephalosporin + metronidazole) and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days) | Drug: Cephalosporin + Metronidazole<br>* intravenous antibiotics injection (3rd generation cephalosporin + metronidazole)and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)<br>|
| No Intervention: No antibiotic<br>bowel rest and then, discharge until tolerable soft diet. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Failure | advancement or recurrence diverticulitis at the same site. | 4-6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay at first admission for diverticulitis |  | up to 2 weeks | 
| total cost of hospitalization for diverticulitis | length of hospital stay | up to 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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uncomplicated diverticulitis, economic cost, hospital stay