UMIN-CTR Clinical Trial

Basic information
Public title	A study on the usefulness of the nasal saline spray method after endoscopic sinus surgery.
Acronym	A study of the saline spray nasal method after ESS
Scientific Title	A study on the usefulness of the nasal saline spray method after endoscopic sinus surgery.
Scientific Title:Acronym	A study of the saline spray nasal method after ESS
Region	Japan

Condition
Condition	Nasal sinuses surgery
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	For patients in the nasal sinuses surgery can not nose cleaning method, conducted saline spray nasal method (dry nose spray ), to examine the usefulness.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Scab amount of the nasal cavity of the postoperative(6 months time after the intervention)
Key secondary outcomes	Amount of bleeding in the nasal cavity

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	As a substitute in the nasal lavage perform the medical treatment in the saline spray nasal. Questionnaire and assess the state of the nasal cavity after 2 weeks, 4 weeks, 8 weeks.
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.Of the chronic sinusitis patients, patients undergoing surgery treatment. 2.Patients document consent of the free will of the person has been obtained.
Key exclusion criteria	1.Patients undergoing surgery of the paranasal sinuses in such as gum incision 2.Malignant tumor example of such benign tumors and upper jaw cancer, such as papilloma 3.Patients with allergy or drug sensitivity constitution 4.Patients principal investigator has determined to be inappropriate as a research subject
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Takeshi Watanabe
Organization	Nagasaki University Hospital
Division name	Otolaryngology-Head and Neck Surgery
Zip code
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7349
Email	twatanabe@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Takeshi Watanabe
Organization	Nagasaki University Hospital
Division name	Otolaryngology-Head and Neck Surgery
Zip code
Address	1-7-1 Sakamoto,Nagasaki
TEL	095-819-7349
Homepage URL
Email	twatanabe@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Nagasaki University Hospital
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
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	2016 Year 05 Month 27 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	2016 Year 02 Month 10 Day
Date of IRB	2021 Year 03 Month 31 Day
Anticipated trial start date	2016 Year 02 Month 10 Day
Last follow-up date	2020 Year 03 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2020 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date	2016 Year 05 Month 27 Day
Last modified on	2021 Year 06 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025926