UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054403 |
|---|---|
| Receipt number | R000061982 |
| Scientific Title | Prospective study on the usefulness of table-mounted uterine manipulator retainer in total laparoscopic hysterectomy |
| Date of disclosure of the study information | 2024/05/15 |
| Last modified on | 2024/05/15 15:14:48 |
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Basic information
Public title
Prospective study on the usefulness of table-mounted uterine manipulator retainer in total laparoscopic hysterectomy
Acronym
Prospective study on the usefulness of table-mounted uterine manipulator retainer in total laparoscopic hysterectomy
Scientific Title
Prospective study on the usefulness of table-mounted uterine manipulator retainer in total laparoscopic hysterectomy
Scientific Title:Acronym
Prospective study on the usefulness of table-mounted uterine manipulator retainer in total laparoscopic hysterectomy
Region
| Japan |
Condition
Condition
myoma, adenomyoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study examines the burden on the surgeon and assistant when ALLY performs uterine manipulator holding, which has been performed by assistants.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Restraint time for surgeon and assistant
Key secondary outcomes
Operating time
Intraoperative complications (intraoperative blood loss, postoperative pain, etc.)
Number of uterine manipulator operations and operation time
Operator satisfaction
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
the ALLY group
Interventions/Control_2
the control group
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
Female
Key inclusion criteria
Patients will be randomly assigned to two groups: an ALLY-using group and a control group.
Key exclusion criteria
If the patient's consent is not obtained, the patient is excluded.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Ota |
Organization
Kawasaki medical school
Division name
Obstetrics and Gynecology
Zip code
7010192
Address
577mathushima kurashiki okayama
TEL
0864621111
gyne@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Ota |
Organization
kawasaki medical shcool
Division name
Obstetrics and Gynecology
Zip code
7010192
Address
577mathushima kurashiki okayama
TEL
0864621111
Homepage URL
okamoto87@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki medical shcool
Institute
Department
Personal name
Funding Source
Organization
Non
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
Kawasaki medical shcool
Address
577mathushima kurashiki okayama
Tel
0864621111
gyne@med.kawasaki-m.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
川崎医科大学附属病院（産婦人科）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 05 | Month | 15 | 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
| 2024 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 05 | Month | 15 | 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
| 2024 | Year | 05 | Month | 15 | Day |
Last modified on
| 2024 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061982
