UMIN-CTR Clinical Trial

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
Email	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
Email	yosuken@tottori-u.ac.jp

Sponsor
Institute	Faculty of Medicine, Tottori University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018091