UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058761 |
|---|---|
| Receipt number | R000067189 |
| Scientific Title | Prospective evaluation of preoperative MRI-based uterine volume assessment to predict the feasibility of transvaginal extraction in laparoscopic and robot-assisted hysterectomy |
| Date of disclosure of the study information | 2025/08/11 |
| Last modified on | 2025/08/11 18:29:47 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective evaluation of preoperative MRI-based uterine volume assessment to predict the feasibility of transvaginal extraction in laparoscopic and robot-assisted hysterectomy
Acronym
Prospective research on preoperative volume assessment by MRI for evaluating transvaginal extraction feasibility in minimally invasive hysterectomy
Scientific Title
Prospective evaluation of preoperative MRI-based uterine volume assessment to predict the feasibility of transvaginal extraction in laparoscopic and robot-assisted hysterectomy
Scientific Title:Acronym
Prospective research on preoperative volume assessment by MRI for evaluating transvaginal extraction feasibility in minimally invasive hysterectomy
Region
| Japan |
Condition
Condition
Benign uterine tumors (uterine fibroids and adenomyosis)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate the relationship between preoperative MRI-estimated uterine volume and maximum fibroid diameter, and the need for transvaginal morcellation in laparoscopic or robot-assisted total hysterectomy, and to develop a predictive model for the feasibility of transvaginal extraction.
Basic objectives2
Others
Basic objectives -Others
To evaluate whether preoperative MRI-based uterine volume assessment can predict the feasibility of transvaginal extraction.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Cut-off values of preoperative MRI-estimated uterine volume and maximum fibroid diameter for predicting the feasibility of extraction without transvaginal morcellation, determined by ROC curve analysis.
Key secondary outcomes
1. Correlation between MRI-estimated uterine volume and actual uterine weight (Pearson's correlation coefficient)
2. Comparison of uterine volume, weight, and maximum fibroid diameter between cases with and without transvaginal morcellation
3. Association between history of vaginal delivery and the performance of transvaginal morcellation
4. Cut-off values of uterine volume and maximum fibroid diameter for extraction without morcellation stratified by history of vaginal delivery
5. Factors associated with extraction without morcellation (history of vaginal delivery, BMI, MRI-estimated uterine volume) analyzed by logistic regression
6. Correlation between MRI-estimated uterine volume and operative time/blood loss
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
| 30 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients scheduled to undergo laparoscopic or robot-assisted total hysterectomy
2. Patients suspected of having uterine fibroids or adenomyosis
3. Patients who have received a full explanation of the study and have provided written informed consent, either personally or via a legal representative
Key exclusion criteria
1. Patients with malignant disease (including endometrial cancer and atypical endometrial hyperplasia) or suspected malignancy
2. Patients deemed inappropriate for inclusion in this study by the principal investigator or sub-investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Kawarai |
Organization
Dokkyo Medical University
Division name
Obstetrics and Gynecology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
+81-282-87-2166
y-kawarai@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Yoshimasa |
| Middle name | |
| Last name | Kawarai |
Organization
Dokkyo Medical University
Division name
Obstetrics and Gynecology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
TEL
+81-282-87-2166
Homepage URL
y-kawarai@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Obstetrics and Gynecology, Dokkyo Medical University
Address
880 Kitakobayashi, Mibu, Shimotsuga, Tochigi
Tel
+81-282-87-2166
y-kawarai@dokkyomed.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
| 2025 | Year | 08 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 single-center, prospective observational study conducted at the Department of Obstetrics and Gynecology, Dokkyo Medical University Hospital. The results will be presented at gynecological and international conferences and published in peer-reviewed journals. All collected data will be anonymized and strictly managed to prevent personal identification. No multicenter collaboration is planned for this study.
Management information
Registered date
| 2025 | Year | 08 | Month | 11 | Day |
Last modified on
| 2025 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067189
