UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016393 |
|---|---|
| Receipt number | R000019040 |
| Scientific Title | A randomized controlled traial for comparison of surgical outcomes under low-pressure CO2 pneumoperitoneum on a standard insufflator versus AirSeal system for laparoscopic hysterectomy. |
| Date of disclosure of the study information | 2015/02/02 |
| Last modified on | 2015/01/30 19:53:08 |
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Basic information
Public title
A randomized controlled traial for comparison of surgical outcomes under low-pressure CO2 pneumoperitoneum on a standard insufflator versus AirSeal system for laparoscopic hysterectomy.
Acronym
Comparison of surgical outcomes on a standard CO2 insufflator versus AirSeal system.
Scientific Title
A randomized controlled traial for comparison of surgical outcomes under low-pressure CO2 pneumoperitoneum on a standard insufflator versus AirSeal system for laparoscopic hysterectomy.
Scientific Title:Acronym
Comparison of surgical outcomes on a standard CO2 insufflator versus AirSeal system.
Region
| Japan |
Condition
Condition
uterine myoma
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare surgical outcomes under low-pressure CO2 pneumoperitoneum on a standard insufflator versus AirSeal system for laparoscopic hysterectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
surgical duration
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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 |
Interventions/Control_1
laparoscopic hysterectomy using standard CO2 insufflator
Interventions/Control_2
laparoscopic hysterectomy using AirSeal system
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
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
Patient with uterine myoma whose uterus is located in pelvic cavity.
Key exclusion criteria
patient suspected malignancy, patient who wishes to pregnant, and patients with bleeding disorder
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Kumakiri |
Organization
Juntendo University Faculty of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
kumakiri@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Kumakiri |
Organization
Juntendo University Faculty of Medicine
Division name
Obstetrics and Gynecology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
03-3813-3111
Homepage URL
kumakiri@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2015 | Year | 02 | Month | 02 | 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
| 2015 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 30 | Day |
Last modified on
| 2015 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019040
