Inguinal HerniaPhase 3RCT-herniationNCT00636831
Prophylactic Antibiotic Use in Hernioplasty
A Phase 3 study testing Antibiotic: cefazolin Sodium in people with Inguinal Hernia, run by Nihon University at 1 site in Japan.
Trial summary
The purpose of this study is to determine whether prophylactic antibiotic use in inguinal hernioplasty are effective in prevention of infectious complication. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Antibiotic: cefazolin Sodium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteJapan
- Study dates
- Jul 2007to Jan 2012
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary inguinal hernia
- Elective surgery
- Must be older than 20 years of age
- Must not have any serious complication
Who cannot join
- Incarceration
- Recurrence
- Drug allergy
- Diabetes mellitus
- Malignant diseases
- Serious heart diseases
Show all 9Show fewer
- Psychological diseases
- Pregnancy
- Have been medicated with corticosteroids
Trial locations and contacts
1 site in 1 country.
Japan1 site
Nihon University School of Medicine, Department of Surgery
Tokyo, 179-0072
About this study
Official title: Prophylactic Antibiotic Use in Inguinal Hernioplasty: A Placebo-controlled, Double-blind Trial
The purpose of this study is to determine whether prophylactic antibiotic use in inguinal hernioplasty are effective in prevention of infectious complication.
- Conditions
- Inguinal Hernia
- Being tested
- Antibiotic: cefazolin Sodium
- Keywords
- Prophylactic, Antibiotic, Infection, Primary case
- Medical subject headings
- Hernia, Inguinal, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic: cefazolin SodiumDrug
1g continuous IV at 30 minutes before starting operation
| Study group | Role | What they receive |
|---|---|---|
| cont | Placebo comparator | Not described Receives: Drug: Antibiotic: cefazolin Sodium |
| intervention | Active comparator | Not described Receives: Drug: Antibiotic: cefazolin Sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
infectious complication
Measured: two year
Secondary outcomes (1)
Recurrence of inguinal hernia
Measured: two year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2008 (estimated)
- Study startJul 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nihon University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takero Mazaki, MD, PhD, Nihon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00636831
- Sponsor's protocol ID
- Hikari-0701
- Acronym
- RCT-herniation
- Status last verified
- Feb 2012
- First submitted
- 10 Mar 2008
- Last updated
- 7 Feb 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotic Use in Inguinal Hernioplasty: A Placebo-controlled, Double-blind Trial
- ClinicalTrials.gov ID
- NCT00636831
- Acronym / sponsor ID
- RCT-herniation / Hikari-0701
- Conditions
- Inguinal Hernia
- Keywords
- Prophylactic, Antibiotic, Infection, Primary case
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Nihon UniversityUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Mar 2008 (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 purpose of this study is to determine whether prophylactic antibiotic use in inguinal hernioplasty are effective in prevention of infectious complication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cont | Placebo comparator | Drug: Antibiotic: cefazolin Sodium |
| intervention | Active comparator | Drug: Antibiotic: cefazolin Sodium |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary inguinal hernia
- Elective surgery
- Must be older than 20 years of age
- Must not have any serious complication
Key exclusion criteria (9 listed)
- Incarceration
- Recurrence
- Drug allergy
- Diabetes mellitus
- Malignant diseases
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 |
|---|---|---|
| Antibiotic: cefazolin Sodium1g continuous IV at 30 minutes before starting operation | Drug | cont, intervention |
Primary outcome
infectious complication
Time frame: two year
1 secondary outcome
Recurrence of inguinal hernia
Time frame: two year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Antibiotic: cefazolin Sodium in people with Inguinal Hernia, run by Nihon University at 1 site in Japan.
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 4 inclusion and 9 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: finished, as of the sponsor's last update on 7 Feb 2012. 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 Japan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
infectious complication (time frame: two year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2012.