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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
Sponsor:
Information provided by (Responsible Party):
Dongtan Sacred Heart Hospital

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.


Condition or disease Intervention/treatment Phase
Simple Diverticular Disease Drug: Cephalosporin + Metronidazole Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Treatment Failure [ Time Frame: 4-6 weeks ]
    advancement or recurrence diverticulitis at the same site.


Secondary Outcome Measures :
  1. length of hospital stay at first admission for diverticulitis [ Time Frame: up to 2 weeks ]
  2. total cost of hospitalization for diverticulitis [ Time Frame: up to 2 weeks ]
    length of hospital stay



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Hwaseong-Si, Gyeonggi-Do, Korea, Republic of, 445-170
Sponsors and Collaborators
Dongtan Sacred Heart Hospital
Investigators
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Principal Investigator: Jong Wan Kim, MD Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dongtan Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT02314013     History of Changes
Other Study ID Numbers: 2014-023
First Posted: December 10, 2014    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: April 2016

Keywords provided by Dongtan Sacred Heart Hospital:
uncomplicated diverticulitis, economic cost, hospital stay

Additional relevant MeSH terms:
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Diverticulitis
Diverticular Diseases
Diverticulum
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Anti-Bacterial Agents
Metronidazole
Cephalosporins
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents