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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039354
Receipt No. 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 2020/02/01

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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 77

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
Email 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
Email prem.sigdel7@gmail.com

Sponsor
Institute Institute of Medicine, Kathmandu
Institute
Department

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
Email 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
2020 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044752

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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