Simple Diverticular DiseaseNCT02314013
Randomized Clinical Trial for the Uncomplicated Diverticulitis in Right Colon
A study testing Cephalosporin + Metronidazole in people with Simple Diverticular Disease, run by Dongtan Sacred Heart Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Simple Diverticular Disease
- What is being tested?
- Cephalosporin + Metronidazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Right-sided colonic diverticulitis
- Uncomplicated diverticulitis
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
Hwaseong-si, Gyeonggi-do, 445-170
About this study
Official title: 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.
Read the 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.
- Conditions
- Simple Diverticular Disease
- Being tested
- Cephalosporin + Metronidazole
- Keywords
- uncomplicated diverticulitis, economic cost, hospital stay
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cephalosporin + MetronidazoleDrug
intravenous antibiotics injection (3rd generation cephalosporin + metronidazole)and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
| Study group | Role | What they receive |
|---|---|---|
| Cephalosporin + Metronidazole | Active comparator | intravenous antibiotics injection (3rd generation cephalosporin + metronidazole) and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days) Receives: Drug: Cephalosporin + Metronidazole |
| No antibiotic | No intervention | bowel rest and then, discharge until tolerable soft diet. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure
advancement or recurrence diverticulitis at the same site.
Measured: 4-6 weeks
Secondary outcomes (2)
length of hospital stay at first admission for diverticulitis
Measured: up to 2 weeks
total cost of hospitalization for diverticulitis
length of hospital stay
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2016
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Simple Diverticular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dongtan Sacred Heart Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong Wan Kim, MD, Principal investigator, Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02314013
- Sponsor's protocol ID
- 2014-023
- Status last verified
- Apr 2016
- First submitted
- 20 Nov 2014
- Last updated
- 16 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31267222
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Clinical Trial for the Management of Uncomplicated Diverticulitis in Right Colon; Non-antibiotics Versus Antibiotics
- ClinicalTrials.gov ID
- NCT02314013
- Acronym / sponsor ID
- 2014-023
- Conditions
- Simple Diverticular Disease
- Keywords
- uncomplicated diverticulitis, economic cost, hospital stay
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Dongtan Sacred Heart HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Feb 2018 (estimated)
- First posted
- 10 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cephalosporin + Metronidazole | Active comparator | Drug: Cephalosporin + Metronidazoleintravenous antibiotics injection (3rd generation cephalosporin + metronidazole) and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days) |
| No antibiotic | No intervention | –bowel rest and then, discharge until tolerable soft diet. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Right-sided colonic diverticulitis
- Uncomplicated diverticulitis
Key exclusion criteria (7 listed)
- Pregnancy
- Refuse to investigation
- Immunosuppressive therapy or immunologic incompetence
- Colonic diverticulitis except right-sided diverticulitis
- Complicated diverticulitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cephalosporin + Metronidazoleintravenous antibiotics injection (3rd generation cephalosporin + metronidazole)and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days) | Drug | Cephalosporin + Metronidazole |
Primary outcome
Treatment Failure
Time frame: 4-6 weeks
advancement or recurrence diverticulitis at the same site.
2 secondary outcomes
length of hospital stay at first admission for diverticulitis
Time frame: up to 2 weeks
total cost of hospitalization for diverticulitis
Time frame: up to 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2016.
- Derived from this study: PubMed 31267222Kim 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.
Related trials for Simple Diverticular Disease
Active, not recruitingEarly Phase 1
FMT in Uncomplicated Diverticulitis
Diverticulitis, Uncomplicated Diverticular Disease
Active, not recruiting
Effect of Nutritional Counseling and Mediterranean Diet on Patients With Diverticular Disease
Diverticular Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong Wan Kim, MD principal investigator
Department of Surgery, Dongtan Sacred Heart Hospital, Hallym University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cephalosporin + Metronidazole in people with Simple Diverticular Disease, run by Dongtan Sacred Heart Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Failure (time frame: 4-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02314013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2016.