UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011359 |
|---|---|
| Receipt number | R000013195 |
| Scientific Title | Comparison of outcomes between single port laparoscopic surgery and 2-port microlaparoscopic surgery for benign ovarian cyst: Randomized controled study |
| Date of disclosure of the study information | 2013/08/10 |
| Last modified on | 2014/05/07 10:02:11 |
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Basic information
Public title
Comparison of outcomes between single port laparoscopic surgery and 2-port microlaparoscopic surgery for benign ovarian cyst: Randomized controled study
Acronym
Minimarry invasive surgery for benign ovarian cyst.
Scientific Title
Comparison of outcomes between single port laparoscopic surgery and 2-port microlaparoscopic surgery for benign ovarian cyst: Randomized controled study
Scientific Title:Acronym
Minimarry invasive surgery for benign ovarian cyst.
Region
| Japan |
Condition
Condition
benign ovarian cyst
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Randomized controled study in comparison between 2 types of minimally invasive laparoscopic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post surgical pain expressed by visual analog scale
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 | Maneuver |
Interventions/Control_1
Single incision laparoscopic surgery
Interventions/Control_2
2-port mirolaparosopic surgery
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Benign ovarian cyst, 2) patient who desires ovarian presevation for furture pregnancy, 3)Maximum diameter of the cyst is less than 6cm
Key exclusion criteria
1)Ovarian endometrioma, 2)suspicious ovarian malignancy, 3) patient who had bleeding disease, 4)patients who had uterine disease, 5) pregnancy
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Jun Kumakiri |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Obstetrics and Gynecology
Zip code
Address
TEL
Homepage URL
kumakiri@jutendo.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
Other
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
| 2013 | Year | 08 | Month | 10 | 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
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | 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
| 2013 | Year | 08 | Month | 03 | Day |
Last modified on
| 2014 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013195
