Evaluation of the effect of Repeated Trans-Urethral Resection of Bladder Tumor on recurrence rate in patients with superficial high grade bladder tumor
Bladder tumor is a common disease. Gold standard of care for a bladder tumor is Trans-Urethral Resection of Bladder Tumor(TURT), which can be curative for nonmuscle invasive tumors compared to need to radical cystectomy for muscle invasive tumors; so accurate tumor staging and grading and complete resection is critical in management of any bladder tumor. Re-TURT may be useful in this regard.
Patients and Methods: Every patient with newly diagnosed bladder tumor is admitted and complete TURT is done. Any patient with nonmuscle invasive high grade TCC is included and randomized according to 6 pieces block in to two groups. Study group patients will be readmitted for Re-TURT 1-6 weeks after initial TURT. Re-TURT is not done for control group. Any residual tumor which was not seen in initial resection as well as the base and margin of previous tumor will be resected again for another pathologic assessment. According to new pathology result, treatment plan will be revised. All patients will be followed for one year with control cystoscopy every 3 months, and recurrence rate will be compared in two groups.
Inclusion criteria: patients with TCC T1, high grade Ta, CIS.
Exclusion criteria: Non TCC tumors, low grade Ta or muscle invasive TCC, previous TURT, very old patients, unsatisfied patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205295641N3
Registration date:2012-08-26, 1391/06/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-08-26, 1391/06/05
Registrant information
Name
Seyed Habibollah Mousavi-bahar
Name of organization / entity
Hamedan University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1823 0829
Email address
shmbahar@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research and technology, Hamadan University of Medical Sciences
Expected recruitment start date
2012-03-10, 1390/12/20
Expected recruitment end date
2014-03-10, 1392/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Repeated Trans-Urethral Resection of Bladder Tumor on recurrence rate in patients with superficial high grade bladder tumor
Public title
Is repeated resection of bladder tumor useful?
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All the patients with TCC of bladder with: Ca. In situ, Ta High grade( G2 or 3), T1. Exclusion criteria: Non TCC Bladder tumor; Muscle invasive TCC; Grade 1 TCC; Very old age and generally poor condition patients; Unsatisfied patients.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
55
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
Hamadan University of Medical sciences
Street address
Shariati cross
City
Hamadan
Postal code
Approval date
2012-02-01, 1390/11/12
Ethics committee reference number
3966/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Bladder tumor
ICD-10 code
C67
ICD-10 code description
Malignant neoplasm of bladder
Primary outcomes
1
Description
Progresion and Recurrence
Timepoint
Every 3 months
Method of measurement
Cystoscopy
2
Description
Progression
Timepoint
Every 3 months
Method of measurement
Pathologic examination
Secondary outcomes
empty
Intervention groups
1
Description
The intervention in study group will be as Repeated Trens-Urethral Resection of Bladder Tumor (ReTURT).
Category
Treatment - Surgery
2
Description
In control group we will not have any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Maedeh Mohseni
Street address
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamadan University of Medical sciences
Full name of responsible person
Haidar Tavilani
Street address
Hamadan University campus, Fahmideh Blvd.
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan 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
Hamadan University of Medical Sciences
Full name of responsible person
Seyed Habibollah Mousavi-bahar
Position
Associated Prof.
Other areas of specialty/work
Street address
Beheshti hospital
City
Hamadan
Postal code
Phone
+98 81 1838 0283
Fax
Email
shmbahar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Seyed Habibollah Mousavi-bahar
Position
associated prof.
Other areas of specialty/work
Street address
Beheshti hospital
City
Hamadan
Postal code
Phone
+98 81 1838 0283
Fax
Email
shmbahar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Maedeh Mohseni
Position
Urology Resident
Other areas of specialty/work
Street address
Beheshti hospital
City
Hamadan
Postal code
Phone
+98 81 1838 0283
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)