UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020396 |
|---|---|
| Receipt number | R000023548 |
| Scientific Title | Effectiveness of Vasopressin During laparoscopic Hysterectomy |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2023/07/09 18:37:22 |
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Basic information
Public title
Effectiveness of Vasopressin During laparoscopic Hysterectomy
Acronym
Vasopressin During laparoscopic Hysterectomy
Scientific Title
Effectiveness of Vasopressin During laparoscopic Hysterectomy
Scientific Title:Acronym
Vasopressin During laparoscopic Hysterectomy
Region
| Japan |
Condition
Condition
Myoma uteri, adenomyosis
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is the evaluation for safety
and efficiency of use of vasopressin during laparoscopic hysterectomy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Operation time, Blood loss.
Key secondary outcomes
Complications, duration of hospitalization.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Injection of dilute vasopressin solution to uterine myometrium
Interventions/Control_2
injection of physiological saline solution to uterine myometrium
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
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
Women who have symptomatic uterine
myomas and/or adenomyosis
Key exclusion criteria
1. Patients with severe complications.
2. Laparoscopic hysterectomy for cervical myoma with a major diameter of more than 10 cm.
3. Patients who are judged to be inappropriate to carry out the study by the medical attendant.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Fumiaki |
| Middle name | |
| Last name | Taniguchi |
Organization
Takanohara Central Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
631-0805
Address
1-3-3 Ukyo, Nara city, Nara, 631-0805, Japan
TEL
0742-71-1030
ftaniguc@gmail.com
Public contact
Name of contact person
| 1st name | Fumiaki |
| Middle name | |
| Last name | Taniguchi |
Organization
Takanohara Central Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
631-0805
Address
1-3-3 Ukyo, Nara city, Nara, 631-0805, Japan
TEL
0742-71-1030
Homepage URL
ftaniguc@gmail.com
Sponsor or person
Institute
Takanohara Central Hospital
Institute
Department
Personal name
Funding Source
Organization
Takanohara Central Hospital
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
Takanohara Central Hospital Ethics Committee
Address
1-3-3 Ukyo, Nara city, Nara, Japan
Tel
0742-71-1030
info@takanohara-ch.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
| 2016 | Year | 01 | 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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 10 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 29 | Day |
Last modified on
| 2023 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023548
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
