UMIN-CTR Clinical Trial

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