UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039354 |
|---|---|
| Receipt number | R000044752 |
| Scientific Title | Bipolar vessel sealing system versus silk ligation of lymphatic vessels in renal transplant recipient lymphatic complications a Randomized controlled trial |
| Date of disclosure of the study information | 2020/02/01 |
| Last modified on | 2021/07/02 09:47:40 |
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Basic information
Public title
Bipolar vessel sealing system versus silk ligation of lymphatic vessels in renal transplant recipient lymphatic complications a Randomized controlled trial
Acronym
Lympatic complication in renal transplantation in bipolar and silk ligation
Scientific Title
Bipolar vessel sealing system versus silk ligation of lymphatic vessels in renal transplant recipient lymphatic complications a Randomized controlled trial
Scientific Title:Acronym
Lympatic complication in renal transplantation in bipolar and silk ligation
Region
| Asia(except Japan) |
Condition
Condition
Ongoing study
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the post renal transplant lymphatic complications between Bipolar vessel sealing system and conventional silk ligation of lymphatic vessels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lymphatic complications
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Bipolar vessel sealing system
Interventions/Control_2
Silk ligation
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
| 10 | years-old | < |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All patients undergoing renal transplantation
Key exclusion criteria
Urinary leakage (drain creatine >2 times serum creatine
Retroperitoneal hemorrhage
Re exploration
Mortality within 90 days
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Prem |
| Middle name | Raj |
| Last name | Sigdel |
Organization
Institute of Medicine, Tribhuvan University Teaching Hospital
Division name
Department of Urology and Kidney Transplant Surgery
Zip code
44608
Address
Maharajgung, Kathmandu
TEL
+9779855065200
prem.sigdel7@gmail.com
Public contact
Name of contact person
| 1st name | Prem |
| Middle name | Raj |
| Last name | Sigdel |
Organization
Institute of Medicine, Tribhuvan University Teaching Hospital
Division name
Department of Urology and Kidney Transplant Surgery
Zip code
44608
Address
Maharajgung, Kathmandu
TEL
+9779855065200
Homepage URL
prem.sigdel7@gmail.com
Sponsor or person
Institute
Institute of Medicine, Kathmandu
Institute
Department
Personal name
Funding Source
Organization
Institute of Medicine
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Nepal
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Medicine
Address
Kathmandu
Tel
0097714413187
irc@iom.edu.np
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
| 2020 | Year | 02 | 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
| 2019 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 01 | Day |
Last modified on
| 2021 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044752
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