UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020396
Receipt No. R000023548
Scientific Title Effectiveness of Vasopressin During laparoscopic Hysterectomy
Date of disclosure of the study information 2016/01/01
Last modified on 2020/07/02

* 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 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
Obsterics 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
Email 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
Email ftaniguc@gmail.com

Sponsor
Institute Takanohara Central Hospital
Institute
Department

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
Email 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 Open public recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 29 Day
Last modified on
2020 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023548

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.