Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon

Simple Diverticular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02314013
• Other study ID #: 2014-023
• Status: Active, not recruiting
• Phase: N/A
• First received: November 20, 2014
• Last updated: November 14, 2016
• Start date: April 2014
• Est. completion date: February 2018

Study information

• Verified date: April 2016
• Source: Dongtan Sacred Heart Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Dontan Sacred Heart hospital Institutional Review Board/Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 132
• Est. completion date: February 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diverticulitis
• Diverticulum
• Simple Diverticular Disease

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine	Hwaseong-Si	Gyeonggi-Do

Sponsors (1)

Lead Sponsor	Collaborator
Dongtan Sacred Heart Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Failure	advancement or recurrence diverticulitis at the same site.	4-6 weeks	Yes
Secondary	length of hospital stay at first admission for diverticulitis		up to 2 weeks	No
Secondary	total cost of hospitalization for diverticulitis	length of hospital stay	up to 2 weeks	No