UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060217 |
|---|---|
| Receipt number | R000068877 |
| Scientific Title | Clinical significance of using warmed saline for effective cleansing of endoscopic lens fogging for endoscopic nasal surgery |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2025/12/27 11:20:45 |
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Basic information
Public title
Using Warm Salt Water to Keep the Camera Clear During Nose Surgery
Acronym
Warm Saline Camera-Clear MethodDuring Nose Surgery
Scientific Title
Clinical significance of using warmed saline for effective cleansing of endoscopic lens fogging for endoscopic nasal surgery
Scientific Title:Acronym
Warmed Saline Lens Anti-Fogging Study in Endoscopic Nasal Surgery
Region
| Japan |
Condition
Condition
Hypertrophic rhinitis or allergic rhinitis requiring submucosal inferior turbinate bone resection
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Lens fogging during endoscopic nasal surgery significantly reduces the visibility of the surgical field, often necessitating interruptions in the procedure and frequent removal of the endoscope. These interruptions can adversely affect the continuity of the surgery and the surgeon's operational efficiency. Lens fogging is thought to result from condensation caused by the temperature difference between the endoscope lens and the humid environment inside the nasal cavity. To address this issue, both automatic endoscope cleaning systems and anti-fogging agents have been developed and are currently in use. While automatic cleaning systems are highly effective, they are expensive and often imported, which can make inventory management challenging. Anti-fogging agents, on the other hand, have a limited effect in preventing condensation due to temperature changes and may prolong surgical interruptions, increasing surgeon stress. In the field of laparoscopic surgery, the use of warmed saline for lens irrigation has been shown in multiple randomized controlled trials to significantly reduce the incidence and severity of lens fogging, thereby improving visibility and procedural continuity. The objective of this study is to apply the lens anti-fogging method using approximately warmed saline, which has demonstrated efficacy in laparoscopic surgery, to endoscopic nasal surgery and to evaluate its clinical significance. Specifically, this study aims to clarify the effects of warmed saline on lens fogging, maintenance of visibility, and smoothness of the surgical procedure in the narrow and highly humid operative field characteristic of endoscopic nasal surgery. The ultimate goal is to provide evidence supporting a simple, safe, and reproducible method for preventing endoscope lens fogging.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of lens cleanings, Total time required to clean lens
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
warmed saline is used to clear lens fogging during endoscopic nasal surgery
Interventions/Control_2
oom-temperature normal saline is used to clear lens fogging during endoscopic nasal surgery
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients presenting with nasal discharge and nasal obstruction as their main complaints.
2.Patients undergoing submucosal inferior turbinate bone resection or posterior nasal neurectomy for the purpose of improving the above symptoms.
3.Patients aged 18 years or older at the time of consent.
4.Patients who have provided written informed consent voluntarily, after fully understanding the study and its procedures.
Key exclusion criteria
1.Patients with a history of unilateral submucosal inferior turbinate bone resection.
2.Patients with a history of unilateral laser submucosal inferior turbinate ablation.
3.Patients with a history of ligation of the common carotid artery or its branches.
4.Patients with a history of nasal or paranasal sinus cancer.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Kanazawa |
Organization
Shizuoka General Hospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
4208527
Address
4-27-1, Kita Ando, Aoi-ku, Shizuoka, Japan
TEL
0542476111
kanazawa_yuji@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Kanazawa |
Organization
Shizuoka General Hospital
Division name
Department of Otolaryngology-Head and Neck Surgery
Zip code
4208527
Address
4-27-1, Kita Ando, Aoi-ku, Shizuoka, Japan
TEL
0542476111
Homepage URL
kanazawa_yuji@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka General Hospital
Address
4-27-1, Kita Ando, Aoi-ku, Shizuoka, Japan
Tel
0542476111
kanazawa_yuji@ent.kuhp.kyoto-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
静岡県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 12 | Month | 27 | Day |
Last modified on
| 2025 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068877
