Comparison of presence of detrusor muscle in pathology report between monopolar conventional TURBT and en-bloc TURBT in bladder mass less than 3cm without past history of bladder mass in Hashemonejad hospital from 1396 to 1397
1- Comparison of detrusor muscle in conventional TURBT and en-bloc TURBT methods
2- Comparison of surgical time in conventional TURBT and en-bloc TURBT methods
3. Comparison of bladder rupture rates in conventional TURBT and en-bloc TURBT methods
4- Comparison of bladder tumor grade in conventional TURBT and en-bloc TURBT methods
5- Comparison of mean hemoglobin reduction in conventional TURBT and en-bloc TURBT methods
Design
A randomized, triple-blind, parallel groups clinical trial
Settings and conduct
Patients underwent conventional TURBT and en bloc TURB at Hasheminejad Hospital following general or spinal anesthesia. The patient, pathologist, and analyzer were unaware of the surgical procedure (triple blindness).
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients with single mass and peduncle mass, tumor size less than 3 cm and no previous history of bladder mass.
Exclusion criteria
Presence of more than one tumor, having previous history of bladder mass, tumor size greater than 3 cm
Intervention groups
Surgery was done in two conventional TURBT techniques using monopolar loop and distilled water for surgical treatment and en-bloc TURBT technique using monoplastic hook and distilled water for surgical treatment
Main outcome variables
Presence of detrusor muscle, duration of surgery, rupture of bladder, hemoglobin loss
General information
Reason for update
Acronym
en bloc TURB
IRCT registration information
IRCT registration number:IRCT20190528043745N1
Registration date:2019-11-16, 1398/08/25
Registration timing:retrospective
Last update:2019-11-16, 1398/08/25
Update count:0
Registration date
2019-11-16, 1398/08/25
Registrant information
Name
Koosha Kamali
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4601 3954
Email address
kamali.k@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2018-08-23, 1397/06/01
Trial completion date
2018-08-23, 1397/06/01
Scientific title
Comparison of presence of detrusor muscle in pathology report between monopolar conventional TURBT and en-bloc TURBT in bladder mass less than 3cm without past history of bladder mass in Hashemonejad hospital from 1396 to 1397
Public title
Comparison of presence of detrusor muscle in pathology report between monopolar conventional TURBT and en-bloc TURBT
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
mass less than 3cm
Exclusion criteria:
past history of bladder mass
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Balance Blocked Randomization using statistical software
Blinding (investigator's opinion)
Triple blinded
Blinding description
patient did not know about surgical technique. Pathologist did not know about surgical technique. Studied groups were introduced to analyzer as A and B groups.
Placebo
Not used
Assignment
Parallel
Other design features
no matter
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemmat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2017-10-08, 1396/07/16
Ethics committee reference number
IR.IUMS.FMD.REC1396.9411254002
Health conditions studied
1
Description of health condition studied
Bladder mass
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
Primary outcomes
1
Description
The presence or absence of muscle tissue
Timepoint
Pathological report up to two weeks after surgery
Method of measurement
Use of a microscope by a pathologist
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group is related to en bloc TURB surgery and includes 30 patients. In this procedure, patients underwent either general or spinal anesthesia under en bloc TURBT surgery using monopolar hooks and distilled water for intraoperative irrigation. Their pathological specimens are examined for the presence of detrusor muscle. After tumor resection, the tumor margin is coagulated about 0.5 cm away. Then, after fixing the three-way foley catheter, the bladder is washed with normal saline. Duration of surgery as well as postoperative complications including hemoglobin loss and bladder rupture were also studied. For all patients, 40 mg mitomycin is injected into the bladder for the first six hours after surgery.
Category
Treatment - Surgery
2
Description
control group: This group is related to conventional TURB surgery and includes 30 patients. In this procedure, patients underwent either general or spinal anesthesia under conventional TURBT surgery using monopolar loop and distilled water for intraoperative irrigation. Their pathological specimens are examined for the presence of detrusor muscle. After tumor resection, the tumor margin is coagulated about 0.5 cm away. Then, after fixing the three-way foley catheter, the bladder is washed with normal saline. Duration of surgery as well as postoperative complications including hemoglobin loss and bladder rupture were also studied. For all patients, 40 mg mitomycin is injected into the bladder for the first six hours after surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Hesheminejad hospital
Full name of responsible person
Koosha Kamali
Street address
Vanak square
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 4457
Email
ehsanzolfi1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Pejman Shadpour
Street address
Vanak square, Hasheminejad hospital
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 4457
Email
info@hkc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hasheminejad hospital
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ehsan Zolfi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
No 21, Namazi avenue, south Jannat abad,
City
Tehran
Province
Tehran
Postal code
1474746767
Phone
O098 21 46013954
Email
ehsanzolfi1@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Koosha Kamali
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Vanak square, Hasheminejad hospital
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 4457
Email
kamali.k@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ehsan Zolfi
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Hasheminejad square, Vanak square
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8864 4457
Email
ehsanzolfi1@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be published.
When the data will become available and for how long
After the paper publication
To whom data/document is available
All persons
Under which criteria data/document could be used
under any circumstances
From where data/document is obtainable
Ehsanzolfi1@gmail.com
What processes are involved for a request to access data/document