UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039119
Receipt number 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 16:43:32

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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 or person

Institute

IOM

Institute

Department

Personal name



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

Value
https://center6.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