UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015746 |
|---|---|
| Receipt number | R000018091 |
| Scientific Title | Endoscopic sinus surgery improves pulmonary function in patients with chronic sinusitis |
| Date of disclosure of the study information | 2014/11/24 |
| Last modified on | 2020/05/14 19:46:53 |
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Basic information
Public title
Endoscopic sinus surgery improves pulmonary function in patients with chronic sinusitis
Acronym
Effect of ESS on pulmonary function
Scientific Title
Endoscopic sinus surgery improves pulmonary function in patients with chronic sinusitis
Scientific Title:Acronym
Effect of ESS on pulmonary function
Region
| Japan |
Condition
Condition
chronic rhinosinusitis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic sinus surgery (ESS) is validated to bronchial asthma from viewpoints of a postoperative peak flow rate, change of the amount of the steroid used, etc. However, there is almost no report which considered the influence of the ESS on a pulmonary function to a sinusitis patient at large. The present study focuses on the benefits of ESS on pulmonary function in patients with chronic sinusitis on the basis of more objective criteria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
FEV1% predicted, PEF1% predicted, fractional exhaled nitric oxide
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Chronic sinusitis patient
2 Resistance or intractableness by conservative medical management.
3 Pansinectomy of both sides
4 The patient in whom an operation and postoperative going to hospital regularly are possible
5 Age is aged 20 and over.
6 A pulmonary function test is possible
7 A questionnaire is possible.
8 It has agreed with research partnership using a consent document.
Key exclusion criteria
1 The case in which ESS is impossible
2 The patient who has done neither a tracheotomy nor a laryngectomy.
3 A patient with the pneumonia and neoplasm for which medical treatment is needed.
4 A patient with diseases, such as acute upper respiratory inflammation
5 The patient under a woman with the possibility of pregnancy, or will, pregnancy, or breast-feeding
6 Those who judged that a research person in charge was unsuitable to a clinical test
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Takeuchi |
Organization
Faculty of Medicine, Tottori University
Division name
Otolaryngology, Head and Neck Surgery
Zip code
683-0826
Address
86 Nishi-cho, Yonago-city, Tottori
TEL
0859-38-6627
oto3175@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Nakamura |
Organization
Faculty of Medicine, Tottori University
Division name
Otolaryngology, Head and Neck Surgery
Zip code
683-0826
Address
86 Nishi-cho, Yonago-city, Tottori
TEL
0859-38-6627
Homepage URL
yosuken@tottori-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Tottori University
Institute
Department
Personal name
Funding Source
Organization
self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tottori university
Address
36-1, Nishi-cho, Yonago
Tel
0859-38-7108
me-kenkyu@ml.adm.tottori-u.ac.jp
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
| 2014 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
Main results already published
Date of protocol fixation
| 2014 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2020 | Year | 12 | Month | 31 | Day |
Other
Other related information
An observation period is postoperative two years.
It will evaluate and inquire in one year and 2 postoperative half a year.
Management information
Registered date
| 2014 | Year | 11 | Month | 24 | Day |
Last modified on
| 2020 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018091
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
