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
1 other identifier
interventional
132
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 20, 2014
CompletedFirst Posted
Study publicly available on registry
December 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedNovember 16, 2016
April 1, 2016
2.6 years
November 20, 2014
November 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Treatment Failure
advancement or recurrence diverticulitis at the same site.
4-6 weeks
Secondary Outcomes (2)
length of hospital stay at first admission for diverticulitis
up to 2 weeks
total cost of hospitalization for diverticulitis
up to 2 weeks
Study Arms (2)
Cephalosporin + Metronidazole
ACTIVE COMPARATORintravenous antibiotics injection (3rd generation cephalosporin + metronidazole) and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
No antibiotic
NO INTERVENTIONbowel rest and then, discharge until tolerable soft diet.
Interventions
intravenous antibiotics injection (3rd generation cephalosporin + metronidazole)and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
Eligibility Criteria
You may qualify if:
- Right-sided colonic diverticulitis
- Uncomplicated diverticulitis
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Hwaseong-si, Gyeonggi-do, 445-170, South Korea
Related Publications (1)
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.
PMID: 31267222DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jong Wan Kim, MD
Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2014
First Posted
December 10, 2014
Study Start
April 1, 2014
Primary Completion
November 1, 2016
Study Completion
February 1, 2018
Last Updated
November 16, 2016
Record last verified: 2016-04