Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon

November 14, 2016 updated by: Dongtan Sacred Heart Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

132

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-Do
      • Hwaseong-Si, Gyeonggi-Do, Korea, Republic of, 445-170
        • Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Failure
Time Frame: 4-6 weeks
advancement or recurrence diverticulitis at the same site.
4-6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
length of hospital stay at first admission for diverticulitis
Time Frame: up to 2 weeks
up to 2 weeks
total cost of hospitalization for diverticulitis
Time Frame: up to 2 weeks
length of hospital stay
up to 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dongtan Sacred Heart Hospital

Investigators

  • Principal Investigator: Jong Wan Kim, MD, Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

December 8, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Estimate)

November 16, 2016

Last Update Submitted That Met QC Criteria

November 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-023

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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