UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000039119
Receipt No. R000044616
Scientific Title Safety and efficacy of monopolar vs bipolar transurethral resection of bladder tumor-A randomized controlled trial
Date of disclosure of the study information 2020/01/11
Last modified on 2020/01/10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Safety and efficacy of Bipolar TURBT
Acronym TURBT: Transurethral resection of bladder tumor
Scientific Title Safety and efficacy of monopolar vs bipolar transurethral resection of bladder tumor-A randomized controlled trial
Scientific Title:Acronym SEMBTURBT
Region
Asia(except Japan)

Condition
Condition bladder carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To compare the safety and efficacy between monopolar and bipolar TURBT.
Basic objectives2 Others
Basic objectives -Others Primary objective: To compare the incidence of obturator jerk between two groups.
Secondary objective: To compare the bladder perforation, decrease in hemoglobin, decease in sodium, resection syndrome, resection time, need of re-operation for recoagulation, blood transfusion, hospital stay, detrussor muscle identification, and the severe artifact in resected specimen between two groups.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Obturator Jerk
Key secondary outcomes the bladder perforation, decrease in hemoglobin, decease in sodium, resection syndrome, resection time, need of re-operation for recoagulation, blood transfusion, hospital stay, detrussor muscle identification, and the severe artifact

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 monopolar device for TURBT
Interventions/Control_2 Bipolar device for TURBT
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
18 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria All patients undergoing TURBT for suspected bladder tumors
Key exclusion criteria Consent withdrawal, bladder tumour other than in the lateral wall, unfit for spinal anesthesia and need of general anesthesia or obturator nerve block.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Manish
Middle name Man
Last name Pradhan
Organization TUTH,IOM
Division name UROLOGY
Zip code 44600
Address Maharajgung,TUTH,IOM.
TEL 9851138833
Email memanishp@gmail.com

Public contact
Name of contact person
1st name manish
Middle name
Last name pradhan
Organization TUTH
Division name UROLOGY
Zip code 44600
Address Maharajgung, TUTH, IOM
TEL 9851138833
Homepage URL
Email memanishp@gmail.com

Sponsor
Institute IOM
Institute
Department

Funding Source
Organization self
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 Research Department, Institutional Review Committee Tribhuvan University Institute of Medicine
Address Maharjgunj-3, P.O. Box: 1524, Kathmandu, Nepal
Tel 0977-01-4413187
Email 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 01 Month 11 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 70
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 Completed
Date of protocol fixation
2017 Year 04 Month 01 Day
Date of IRB
2017 Year 04 Month 21 Day
Anticipated trial start date
2017 Year 05 Month 01 Day
Last follow-up date
2019 Year 05 Month 01 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 01 Month 10 Day
Last modified on
2020 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044616

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.