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Comparative efficacy of Holmium laser with local anesthesia and transurethral resection of the bladder tumor (TURBT) in patients with non-muscle invasive

Protocol summary

Summary
In this randomized clinical trial 76 patients with Papillary bladder tumors (<3 cm) that has therapeutic action (including TuRBT, laser or intravesical chemotherapy) has been done for them and willing to participate in the study and to complete the consent form, discussed and careful history taken from patients at the first visit and complete clinical examination, blood test for creatinine, hemoglobin, PSA, Ca, P, LFT, urine analysis and urine cytology are. Aspanyal anesthesia or general anesthesia (depending on clinical condition and comorbidities) and Holmium laser bladder tumor with local anesthesia (injection of 20 mL of 2% lidocaine gel) are included. group external laser treatment and other therapies (such as TURBT, intravesical chemotherapy or radical cystectomy) will start for the patient. Webster bladder tumor mass of cold cup biopsy specimens and samples from TuRBT laser group is sent to pathology. The results of the duration of hospital stay and postoperative catheterization time, there hematuria and the amount of irrigation fluid used during surgery, duration of surgery, the number of reflex obteratur and perforation of the bladder, causing dysuria and frequency after practice, creating UTI and other complications after surgery and the rate of recurrence, the recurrence and progression of tumor stage and Grade 18 months, and complications and recurrence rates between the two groups at 1, 3, 6, 12 and 18 months after treatment review and compare

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201701078146N18
Registration date: 2017-03-12, 1395/12/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-12, 1395/12/22
Registrant information
Name
Mohammadreza Razaghi
Name of organization / entity
Laser application in medical sciences research center
Country
Iran (Islamic Republic of)
Phone
+98 21 2271 8021
Email address
laser.cntr@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2017-03-21, 1396/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative efficacy of Holmium laser with local anesthesia and transurethral resection of the bladder tumor (TURBT) in patients with non-muscle invasive
Public title
Comparative efficacy of Holmium laser with local anesthesia and transurethral resection of the bladder tumor (TURBT) in patients with non-muscle invasive
Purpose
Treatment
Inclusion/Exclusion criteria
Papillary bladder tumors (<3 cm) that has therapeutic action (including TuRBT, laser or intravesical chemotherapy) has been done for them and willing to participate in the study.
Age
From 25 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Organizational committee of ethics in biomedical research Shahid Beheshti University of Medical Scie
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Postal code
Approval date
2015-08-23, 1394/06/01
Ethics committee reference number
IR.SBMU.RAM.REC.1394.157

Health conditions studied

1

Description of health condition studied
Bladder tumors
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder

Primary outcomes

1

Description
Recurrence and progression of stage & grade
Timepoint
1, 3, 6, 12 and 18 months after treatment
Method of measurement
Cystoscopy

Secondary outcomes

empty

Intervention groups

1

Description
Control group: TuRBT
Category
Other

2

Description
Intervention group: Holmium laser for patients holmium laser to perform laser treatment process and not a limitation of this method in tissue obtained by biopsy of the tumor cold enough for grading the probability of incomplete tumor grading will be explained further treatment delay
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
7th Floor, Bldg No.2 SBUMS, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran, Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Laser Application Research Centre
Full name of responsible person
Mohammad Reza Razaghi ,MD
Position
Head of research center
Other areas of specialty/work
Street address
Shohada Hospital-Tajrish
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Laser Application Research Centre
Full name of responsible person
Mohammad Reza Razaghi,MD
Position
Professor
Other areas of specialty/work
Street address
Shohada Hospital-Tajrish
City
Teharn
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Laser Application Research Centre
Full name of responsible person
Zahra Razaghi
Position
Research Expert
Other areas of specialty/work
Street address
Shohada Hospital, Tagrish sq.
City
Tehran
Postal code
Phone
+98 21 2274 9221
Fax
Email
laser.cntr@sbmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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