UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052864 |
|---|---|
| Receipt number | R000060125 |
| Scientific Title | Hot Saline Irrigation for Hemostasis in Endoscopic Sinus Surgery |
| Date of disclosure of the study information | 2023/11/29 |
| Last modified on | 2024/09/14 18:37:46 |
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Basic information
Public title
Hot Saline Irrigation for Hemostasis in Endoscopic Sinus Surgery
Acronym
Hot Saline Irrigation for Hemostasis in Endoscopic Sinus Surgery
Scientific Title
Hot Saline Irrigation for Hemostasis in Endoscopic Sinus Surgery
Scientific Title:Acronym
Hot Saline Irrigation for Hemostasis in Endoscopic Sinus Surgery
Region
| Japan |
Condition
Condition
Bilateral chronic rhinosinusitis with nasal polyps
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of hot saline irrigation for endoscopic sinus surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Boezaart score
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Hot saline irrigation
Interventions/Control_2
Normal saline irrigation
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with bilateral chronic rhinosinusitis with nasal polyps undergoing endoscopic sinus surgery
Key exclusion criteria
1.Patients with prior sinus surgery.
2.Patients with odontogenic sinusitis or mycotic sinusitis.
3.Patients with a polyp score of 0-1 or with >=2 side-to-side discrepancy.
4.Patients suspect for collagen disease associated chronic rhinosinusitis.
5.Patients with antiplatelet/anticoagulant therapy.
6.Patients with hepatitis B/C or other blood-borne infections.
7.Patients with uncontrolled diabetes.
8.Immunosuppressed patients.
9.Patients in suboptimal general health.
10.Patients treated with investigational drugs within the past 3 months.
11.Patients deemed unsuitable by the investigator or sub-investigator.
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Makihara |
Organization
Okayama university hospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357307
smakihara@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiichiro |
| Middle name | |
| Last name | Makihara |
Organization
Okayama University Hospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357307
Homepage URL
smakihara@okayama-u.ac.jp
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
Funding Source
Organization
The Japanese Foundation for Research and Promotion of Endoscopy
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, and Okayama University hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-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
| 2023 | Year | 11 | Month | 29 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2024 | Year | 01 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 21 | Day |
Last modified on
| 2024 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060125
