UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020728 |
|---|---|
| Receipt number | R000023916 |
| Scientific Title | Clinical study of robotic-assisted laparoscopic surgery for uterine cancer |
| Date of disclosure of the study information | 2016/01/25 |
| Last modified on | 2016/01/25 14:48:40 |
* 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
Clinical study of robotic-assisted laparoscopic surgery for uterine cancer
Acronym
Robotic-assisted laparoscopic surgery for uterine cancer
Scientific Title
Clinical study of robotic-assisted laparoscopic surgery for uterine cancer
Scientific Title:Acronym
Robotic-assisted laparoscopic surgery for uterine cancer
Region
| Japan |
Condition
Condition
Uterine cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Safety of surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Adverse effect of surgery
Key secondary outcomes
Surgical outcome
Postoperative pain
Hospital stay
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Robotic-assisted surgery
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
1)Preoperative diagnosis is uterine cancer
2)Need for laparotomy
3)Patient's age is from 20years old to 80years old
4)Performance status is from 0 to 1
5)That consent is obtained
Key exclusion criteria
1)Severe heart disease or cerebral vascular disease
2)Anticoaglant therapy cannot be washout
3)History of radiation therapy to abdomen
4)Severe liver disease
5)Severe kidney disease
6)The person in charge is determined to be inappropriate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoko kato |
Organization
Kyushu university
Division name
Gynecology and Obstetrics
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-5395
kenjou@med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Kenjo |
Organization
Kyushu university hospital
Division name
Gynecology and obstetrics
Zip code
Address
3-1-1 Maidashi Higashi-ku Fukuoka
TEL
092-642-5395
Homepage URL
kenjou@med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu university
Institute
Department
Personal name
Funding Source
Organization
Kyushu university
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
| 2016 | Year | 01 | Month | 25 | 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 | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | 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
| 2016 | Year | 01 | Month | 25 | Day |
Last modified on
| 2016 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023916
