Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon
NCT ID: NCT02314013
Last Updated: 2016-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
132 participants
INTERVENTIONAL
2014-04-30
2018-02-28
Brief Summary
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The hypothesis is that patients having acute uncomplicated diverticulitis at right-sided colon will be recovered without antibiotics.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cephalosporin + Metronidazole
intravenous antibiotics injection (3rd generation cephalosporin + metronidazole) and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
Cephalosporin + Metronidazole
intravenous antibiotics injection (3rd generation cephalosporin + metronidazole)and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
No antibiotic
bowel rest and then, discharge until tolerable soft diet.
No interventions assigned to this group
Interventions
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Cephalosporin + Metronidazole
intravenous antibiotics injection (3rd generation cephalosporin + metronidazole)and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
Eligibility Criteria
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Inclusion Criteria
* Uncomplicated diverticulitis
Exclusion Criteria
* 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)
18 Years
80 Years
ALL
No
Sponsors
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Dongtan Sacred Heart Hospital
OTHER
Responsible Party
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Principal Investigators
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Jong Wan Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Locations
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Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Hwaseong-si, Gyeonggi-do, South Korea
Countries
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References
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Kim JY, Park SG, Kang HJ, Lim YA, Pak KH, Yoo T, Cho WT, Shin DW, Kim JW. Prospective randomized clinical trial of uncomplicated right-sided colonic diverticulitis: antibiotics versus no antibiotics. Int J Colorectal Dis. 2019 Aug;34(8):1413-1420. doi: 10.1007/s00384-019-03343-w. Epub 2019 Jul 2.
Other Identifiers
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2014-023
Identifier Type: -
Identifier Source: org_study_id