UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030133 |
|---|---|
| Receipt number | R000033724 |
| Scientific Title | Preventive surgery to improve postoperative lymphedema in lower limb after total hysterectomy by lymphatic venous anastomosis procedure utilizing da Vinci Surgical System (Phase I study) |
| Date of disclosure of the study information | 2017/12/07 |
| Last modified on | 2018/11/06 11:12:03 |
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Basic information
Public title
Preventive surgery to improve postoperative lymphedema in lower limb after total hysterectomy by lymphatic venous anastomosis procedure utilizing da Vinci Surgical System (Phase I study)
Acronym
Lymphatic venous anastomosis assisted by da Vinci Surgical System (Phase I Study)
Scientific Title
Preventive surgery to improve postoperative lymphedema in lower limb after total hysterectomy by lymphatic venous anastomosis procedure utilizing da Vinci Surgical System (Phase I study)
Scientific Title:Acronym
Lymphatic venous anastomosis assisted by da Vinci Surgical System (Phase I Study)
Region
| Japan |
Condition
Condition
Endometrial cancer
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety of robot-assisted lymphatic venous anastomosis procedure in lower limb lymphedema developed after total hysterectomy.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Intra and postoperative complication, prognosis
Key secondary outcomes
5 year survival, post-operative incidence of lower limb lymphedema
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
Prevention
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Lymphatic venous anastomosis utilizing da Vinci Surgical System
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
| Not applicable |
Gender
Female
Key inclusion criteria
Endometrial cancer, requiring pelvic and/or paraaortic lymphadenectomy.
Key exclusion criteria
Cases in which robot-assisted surgery or lymphatic venous anastomosis is technically unfeasible or unnecessary, due to complications or other reasons.
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sasaki |
Organization
CHIBA TOKUSHUKAI HOSPITAL
Division name
Gynecology
Zip code
Address
2-11-1 Takanedai, Funabashi-shi, Chiba Japan
TEL
047-466-7111
hrssasaki0226@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Sasaki |
Organization
CHIBA TOKUSHUKAI HOSPITAL
Division name
Gynecology
Zip code
Address
2-11-1 Takanedai, Funabashi-shi, Chiba Japan
TEL
047-466-7111
Homepage URL
hrssasaki0226@gmail.com
Sponsor or person
Institute
CHIBA TOKUSHUKAI HOSPITAL
Institute
Department
Personal name
Funding Source
Organization
CHIBA TOKUSHUKAI 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
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
| 2017 | Year | 12 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 10 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 08 | 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
| 2017 | Year | 11 | Month | 27 | Day |
Last modified on
| 2018 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033724
