UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003480 |
|---|---|
| Receipt number | R000004168 |
| Scientific Title | Evaluation of feasibility and safety of Laparoscopic and Endoscopic Single port Surgery (LESS) in urologic laparoscopic surgery |
| Date of disclosure of the study information | 2010/05/01 |
| Last modified on | 2012/12/09 16:04:24 |
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Basic information
Public title
Evaluation of feasibility and safety of Laparoscopic and Endoscopic Single port Surgery (LESS) in urologic laparoscopic surgery
Acronym
Evaluation of feasibility and safety of LESS
Scientific Title
Evaluation of feasibility and safety of Laparoscopic and Endoscopic Single port Surgery (LESS) in urologic laparoscopic surgery
Scientific Title:Acronym
Evaluation of feasibility and safety of LESS
Region
| Japan |
Condition
Condition
All urologic disease for which traditional laparoscopic surgery was indicated.
Classification by specialty
| Urology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and safety of LESS compared to classical laparoscopic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
feasibility and safety of LESS: ex. incidence rate of additional surgical port, open conversion, and operation time
Key secondary outcomes
Incidence rate of complications
Usage of analgesia
VAS pain score after operation, day1,2,4 and 7
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Laparoscopic and Endoscopic Single-port Surgery (LESS)
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
| Not applicable |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The patients of whom therapy is indicated to classical laparoscopic surgery and who wants to receive single port laparoscopic surgery
Key exclusion criteria
Performance status 2 and morethan 2
Age;85 and morethan 85
ASA score 3 and over 3
BMI(body mass index); 30 and over 30
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Matsuda |
Organization
Hirakata hospital, Kansai Medical University
Division name
Department Urology and Andrology
Zip code
Address
2-3-1 Shin-machi, Hirakata, Osaka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hirakata hospital, Kansai Medical University
Division name
Department Urology and Andrology
Zip code
Address
2-3-1 Shin-machi, Hirakata, Osaka, Japan
TEL
Homepage URL
Sponsor or person
Institute
Department Urology and Andrology, Hirakata hospital, Kansai Medical University
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
None
Name of secondary funder(s)
None
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
| 2010 | Year | 05 | 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
| 2010 | Year | 03 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | 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
| 2010 | Year | 04 | Month | 13 | Day |
Last modified on
| 2012 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004168
