Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon
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|ClinicalTrials.gov Identifier: NCT02314013|
Recruitment Status : Unknown
Verified April 2016 by Dongtan Sacred Heart Hospital.
Recruitment status was: Active, not recruiting
First Posted : December 10, 2014
Last Update Posted : November 16, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Simple Diverticular Disease||Drug: Cephalosporin + Metronidazole||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Randomized Clinical Trial for the Management of Uncomplicated Diverticulitis in Right Colon; Non-antibiotics Versus Antibiotics|
|Study Start Date :||April 2014|
|Actual Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||February 2018|
Active Comparator: Cephalosporin + Metronidazole
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
intravenous antibiotics injection (3rd generation cephalosporin + metronidazole)and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
No Intervention: No antibiotic
bowel rest and then, discharge until tolerable soft diet.
- Treatment Failure [ Time Frame: 4-6 weeks ]advancement or recurrence diverticulitis at the same site.
- length of hospital stay at first admission for diverticulitis [ Time Frame: up to 2 weeks ]
- total cost of hospitalization for diverticulitis [ Time Frame: up to 2 weeks ]length of hospital stay
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): NCT02314013
|Korea, Republic of|
|Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine|
|Hwaseong-Si, Gyeonggi-Do, Korea, Republic of, 445-170|
|Principal Investigator:||Jong Wan Kim, MD||Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine|