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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019604
Receipt No. R000022350
Scientific Title Study of perioperative antibiotics for tonsillectomy
Date of disclosure of the study information 2015/12/01
Last modified on 2015/11/02

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Basic information
Public title Study of perioperative antibiotics for tonsillectomy
Acronym Study of the effect by the preoperative azithromycine oral administration
Scientific Title Study of perioperative antibiotics for tonsillectomy
Scientific Title:Acronym Study of the effect by the preoperative azithromycine oral administration
Region
Japan

Condition
Condition chronic tonsillitis
obstructive sleep apnea syndrome
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Study of the efficacy for the perioperative prevention of infection of the azithromycin oral administration
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes It is one week from beginning of dosage about fever, pain, bleeding
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The study population consisted of patients who were examined and underwent palatine tonsillectomy at Nagoya University Hospital.
Key exclusion criteria Patients with a history of hypersensitivity to ingredients of the drugs to be prescribed, patients under 15 years of age, and those being treated with other antimicrobial agents were excluded from the study.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironao Otake
Organization Nagoya University Graduate School of Medicine
Division name Department of Otorhinolaryngology,Head and Neck surgery, Sleep Medicine
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 0527442323
Email hiro07@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironao Otake
Organization Nagoya University Graduate School of Medicine
Division name Department of Otorhinolaryngology,Head and Neck surgery, Sleep Medicine
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 0527442323
Homepage URL
Email hiro07@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 03 Month 12 Day
Date of IRB
Anticipated trial start date
2013 Year 03 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The study population consisted of patients who were examined and underwent palatine tonsillectomy at Nagoya University Hospital between August 2010 and February 2013. The disorders for which the surgical intervention was indicated were chronic tonsillitis, sleep apnea syndrome, tonsillar focal infection, and tonsillar hypertrophy. Patients with a history of hypersensitivity to ingredients of the drugs to be prescribed, patients under 15 years of age, and those being treated with other antimicrobial agents were excluded from the study.
Patients in the AZM treated group received a sustained release AZM preparation as a single 2 gram oral dose only once on Day 2 before the operation. Patients in the CEZ treated group were administered CEZ intravenously starting 30 minutes before initiation of the operation, at 4 hours postoperatively, and then twice daily for 3 days beginning on the day following the operation.
Assessments were made with respect to the incidence of SSI, that of postoperative bleeding, postoperative pain, duration of hospitalization, and adverse reactions possibly ascribable to drugs. As for SSI, the patients condition was judged according to the presence or absence of pyrexia, i.e. temperature above 38 degree, and hematologic or blood biochemical findings. The severity of postoperative pain was rated on the basis of the number of days on which the patient received non steroidal anti inflammatory drugs NSAIDs for pain management.

Management information
Registered date
2015 Year 11 Month 02 Day
Last modified on
2015 Year 11 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022350

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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