UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022493 |
|---|---|
| Receipt number | R000025926 |
| Scientific Title | A study on the usefulness of the nasal saline spray method after endoscopic sinus surgery. |
| Date of disclosure of the study information | 2016/05/27 |
| Last modified on | 2021/06/08 12:03:37 |
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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
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
twatanabe@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025926
| Research Plan | |
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| 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 |
