UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060387 |
|---|---|
| Receipt number | R000069084 |
| Scientific Title | Oral complications after general anesthesia: a retrospective study |
| Date of disclosure of the study information | 2026/02/01 |
| Last modified on | 2026/01/17 11:40:08 |
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Basic information
Public title
Oral complications after general anesthesia: a retrospective study
Acronym
Oral complications after general anesthesia: a retrospective study
Scientific Title
Oral complications after general anesthesia: a retrospective study
Scientific Title:Acronym
Oral complications after general anesthesia: a retrospective study
Region
| Japan |
Condition
Condition
Surgical patients who received general anesthesia
Classification by specialty
| Oto-rhino-laryngology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the postoperative oral complications in surgical patients who underwent general anesthesia, particularly aphthous stomatitis and blisters related to airway management, as well as tongue swelling, tongue ulcers, taste disorders, and tongue immobility.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of postoperative oral complications considered to be caused by airway management during general anesthesia
Key secondary outcomes
Profiles of the patients with postoperative oral complications
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent general anesthesia using tracheal intubation or a supraglottic airway, 2) patients who were examined by an otolaryngologist within 30 days after surgery for oral complications related to airway management.
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Shigekazu |
| Middle name | |
| Last name | Sugino |
Organization
Tohoku University
Division name
Tohoku University Graduate School of Medicine, Dept. of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
Masui-ka Ikyoku, Byo-to Nishi 3F, Tohoku University Hospital, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-717-7321
shigekazu.sugino.d3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Shigekazu |
| Middle name | |
| Last name | Sugino |
Organization
Tohoku University
Division name
Tohoku University Graduate School of Medicine, Dept. of Anesthesiology and Perioperative Medicine
Zip code
980-8574
Address
Byo-to Nishi 3F, Tohoku University Hospital, Seiryo-machi 1-1, Aoba-ku, Sendai, Miyagi, JAPAN
TEL
022-717-7321
Homepage URL
shigekazu.sugino.d3@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Shigekazu Sugino
Funding Source
Organization
None
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
Ethics Committee Tohoku University Graduate School of Medicine
Address
Seiryo-machi 2-1, Aoba-ku, Sendai, Miyagi 980-8575, JAPAN
Tel
022-728-4105
ec-med@grp.tohoku.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
| 2026 | Year | 02 | 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 | 25 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients diagnosed with stomatitis, pharyngeal ulcers, or tongue ulcers by an otolaryngologist at Tohoku University Hospital from January 2016 to December 2025 over a 10-year period will be extracted from medical records.
Management information
Registered date
| 2026 | Year | 01 | Month | 17 | Day |
Last modified on
| 2026 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069084
