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Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02314013
Enrollment
132
Registered
2014-12-10
Start date
2014-04-30
Completion date
2018-02-28
Last updated
2016-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simple Diverticular Disease

Keywords

uncomplicated diverticulitis, economic cost, hospital stay

Brief summary

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

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.

Interventions

DRUGCephalosporin + Metronidazole

intravenous antibiotics injection (3rd generation cephalosporin + metronidazole)and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)

Sponsors

Dongtan Sacred Heart Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Treatment Failure4-6 weeksadvancement or recurrence diverticulitis at the same site.

Secondary

MeasureTime frameDescription
length of hospital stay at first admission for diverticulitisup to 2 weeks
total cost of hospitalization for diverticulitisup to 2 weekslength of hospital stay

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026