Clinical trial NCT02314013: Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon
Official title: Prospective Randomized Clinical Trial for the Management of Uncomplicated Diverticulitis in Right Colon; Non-antibiotics Versus Antibiotics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Simple Diverticular Disease
Keywords: uncomplicated diverticulitis, economic cost, hospital stay
Lead sponsor: Dongtan Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2014-12-10
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Treatment Failure
timeFrame: 4-6 weeks
Secondary outcomes:
measure: length of hospital stay at first admission for diverticulitis
timeFrame: up to 2 weeks
measure: total cost of hospitalization for diverticulitis
timeFrame: up to 2 weeks
Other outcomes:
Locations:
city: Hwaseong-Si
country: Korea, Republic of
facility: Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
state: Gyeonggi-Do
Study officials:
affiliation: Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
name: Jong Wan Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.