UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031794 |
|---|---|
| Receipt number | R000036264 |
| Scientific Title | Evaluation of efficacy and safety of laparoscopic ureteral reconstruction |
| Date of disclosure of the study information | 2018/03/24 |
| Last modified on | 2020/03/20 09:09:15 |
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Basic information
Public title
Evaluation of efficacy and safety of laparoscopic ureteral reconstruction
Acronym
Evaluation of efficacy and safety of laparoscopic ureteral reconstruction
Scientific Title
Evaluation of efficacy and safety of laparoscopic ureteral reconstruction
Scientific Title:Acronym
Evaluation of efficacy and safety of laparoscopic ureteral reconstruction
Region
| Japan |
Condition
Condition
pelvic tumor, pelvic inflammatory disease
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy and safety of laparoscopic ureteral reconstruction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To compare the occurrence rate of total adverse events within 12 months after the surgery among the open and laparoscopic ureteral reconstruction.
Key secondary outcomes
the occurence rate of each adverse event, the usage of analgetic, length of hospital stay
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
laparoscopic ureteral reconstruction
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who undergo laparoscopic resection for pelvic lesions requiring simultaneous partial ureterectomy.
Key exclusion criteria
1:patients with long defective ureter.
2:patients who are not eligible for laparoscopic ureteral reconstruction
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Majima |
Organization
Nagoya University Graduate School of Medicine
Division name
Urology
Zip code
466-8560
Address
65, Tsuruma-cho, Shouwa-ku, Nagoya-shi, Aichi-ken
TEL
0527442984
majima@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Majima |
Organization
Nagoya University Graduate School of Medicine
Division name
Urology
Zip code
466-8560
Address
65, Tsuruma-cho, Shouwa-ku, Nagoya-shi, Aichi-ken
TEL
0527442984
Homepage URL
majima@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School 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
IRB, Nagoya University Graduate School of Medicine
Address
65, Tsuruma-cho, Shouwa-ku, Nagoya-shi, Aichi-ken
Tel
0527412111
nagoya@esct.bvits.com
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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 24 | 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
| 2018 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2018 | 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
| 2018 | Year | 03 | Month | 19 | Day |
Last modified on
| 2020 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036264
