Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon
Primary Purpose
Simple Diverticular Disease
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cephalosporin + Metronidazole
Sponsored by
About this trial
This is an interventional treatment trial for Simple Diverticular Disease focused on measuring uncomplicated diverticulitis, economic cost, hospital stay
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)
Sites / Locations
- Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Cephalosporin + Metronidazole
No antibiotic
Arm Description
intravenous antibiotics injection (3rd generation cephalosporin + metronidazole) and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
bowel rest and then, discharge until tolerable soft diet.
Outcomes
Primary Outcome Measures
Treatment Failure
advancement or recurrence diverticulitis at the same site.
Secondary Outcome Measures
length of hospital stay at first admission for diverticulitis
total cost of hospitalization for diverticulitis
length of hospital stay
Full Information
NCT ID
NCT02314013
First Posted
November 20, 2014
Last Updated
November 14, 2016
Sponsor
Dongtan Sacred Heart Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02314013
Brief Title
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
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
February 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dongtan Sacred Heart Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Simple Diverticular Disease
Keywords
uncomplicated diverticulitis, economic cost, hospital stay
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cephalosporin + Metronidazole
Arm Type
Active Comparator
Arm Description
intravenous antibiotics injection (3rd generation cephalosporin + metronidazole) and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
Arm Title
No antibiotic
Arm Type
No Intervention
Arm Description
bowel rest and then, discharge until tolerable soft diet.
Intervention Type
Drug
Intervention Name(s)
Cephalosporin + Metronidazole
Intervention Description
intravenous antibiotics injection (3rd generation cephalosporin + metronidazole)and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
Primary Outcome Measure Information:
Title
Treatment Failure
Description
advancement or recurrence diverticulitis at the same site.
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
length of hospital stay at first admission for diverticulitis
Time Frame
up to 2 weeks
Title
total cost of hospitalization for diverticulitis
Description
length of hospital stay
Time Frame
up to 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jong Wan Kim, MD
Organizational Affiliation
Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
City
Hwaseong-Si
State/Province
Gyeonggi-Do
ZIP/Postal Code
445-170
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
31267222
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.
Results Reference
derived
Learn more about this trial
Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon
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