UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060380 |
|---|---|
| Receipt number | R000069053 |
| Scientific Title | A retrospective observational study of clinical outcomes of hysteroscopic myomectomy at Sano Hospital |
| Date of disclosure of the study information | 2026/01/16 |
| Last modified on | 2026/01/16 16:37:23 |
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Basic information
Public title
A study evaluating the outcomes of hysteroscopic myomectomy performed at Sano Hospital
Acronym
Sano-TCR Study
Scientific Title
A retrospective observational study of clinical outcomes of hysteroscopic myomectomy at Sano Hospital
Scientific Title:Acronym
Sano-TCR-ROS
Region
| Japan |
Condition
Condition
uterine leiomyoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to retrospectively analyze the clinical outcomes and perioperative complications of hysteroscopic myomectomy performed at Sano Hospital and to evaluate the effectiveness and safety of this surgical approach.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of complete resection in a single hysteroscopic myomectomy session
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients who underwent hysteroscopic myomectomy at Sano Hospital.
Key exclusion criteria
Patients with insufficient medical records that prevent evaluation of the primary outcome.
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Shigeo |
| Middle name | |
| Last name | Inoue |
Organization
Sano Hospital
Division name
Department of Gynecology
Zip code
655-0031
Address
2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Hyogo, Japan
TEL
0787851000
inoueshigeo@msn.com
Public contact
Name of contact person
| 1st name | Shigeo |
| Middle name | |
| Last name | Inoue |
Organization
Sano Hospital
Division name
Department of Gynecology
Zip code
655-0031
Address
2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Hyogo, Japan
TEL
0787861000
Homepage URL
inoueshigeo@msn.com
Sponsor or person
Institute
Sano Hospital
Institute
Department
Personal name
Funding Source
Organization
Sano 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
Ethics Committee, Sano Hospital
Address
2-5-1 Shimizugaoka, Tarumi-ku, Kobe, Hyogo, Japan
Tel
0787851000
info@sano-hospital.or.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 | 01 | Month | 16 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=XXXXXX
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=XXXXXX
Number of participants that the trial has enrolled
600
Results
In this retrospective observational study, approximately 600 patients who underwent hysteroscopic myomectomy at Sano Hospital were analyzed. The primary outcome, the rate of complete resection in a single session, was favorable, and no serious perioperative complications were observed. Detailed results are currently being prepared for publication.
Results date posted
| 2026 | Year | 01 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Approximately 600 patients who underwent hysteroscopic myomectomy at Sano Hospital were included. Baseline clinical characteristics such as age, myoma size, and location were retrospectively collected from medical records.
Participant flow
All patients who underwent hysteroscopic myomectomy during the study period and met the eligibility criteria were included in the analysis. No additional exclusions were applied.
Adverse events
Perioperative adverse events were retrospectively evaluated using medical records. No serious adverse events were observed.
Outcome measures
The primary outcome measure was the rate of complete resection in a single session. Secondary outcomes included the incidence of perioperative complications.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a retrospective observational study conducted at Sano Hospital using existing medical records. No additional interventions were performed, and clinical outcomes and perioperative complications were analyzed based on routine clinical data.
Management information
Registered date
| 2026 | Year | 01 | Month | 16 | Day |
Last modified on
| 2026 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069053
