UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019604
Receipt number 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 17:23:56

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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 or person

Institute

Nagoya University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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