The effect of tattoo markers in marking the tumor location in the ease of finding the tumor in patients who are candidates for Re TURBT
Design
A clinical trial with two groups of patients: parallel, therapeutic, balanced block randomization, single-blind (patient). Twenty patients referred to Sinai Hospital.
Settings and conduct
In the group of this clinical trial at Sina Hospital in Tehran, Urology Research Centre, single-blind (patient) Weber balanced block randomization will be performed on 20 patients. Patients are divided into two groups: The first group is Re-TURBT candidate patients who have markings with tattoo ink. The second group is Re-TURBT candidate patients who do not have markings with tattoo ink.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Bladder tumor patients referred for the first time (primary). The size of the tumor is less than 3 cm. The tumor is solitary. Non metastatic tumor.High grade tumor.Informed consent from patients.
Exclusion criteria: Multifocal tumor. The volume of the patient's bladder should be small. The tumor is recurrent. The patient is not a candidate for reTURBT
Intervention groups
The present study is a single-blind randomized clinical trial study. The participant will not know the randomization method.
Intervention group (Re TURBT candidate patients who have markings with tattoo ink).
Control group (Re TURBT candidate patients who do not have markings with tattoo ink).
Main outcome variables
Determining the success rate and feasibility of identifying the location of the tumor using tattoo ink
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043991N24
Registration date:2023-12-09, 1402/09/18
Registration timing:prospective
Last update:2023-12-09, 1402/09/18
Update count:0
Registration date
2023-12-09, 1402/09/18
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-20, 1402/12/01
Expected recruitment end date
2025-02-19, 1403/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of tattoo markers on marking the bladder tumor place for reTURBT :An Interventional Randomized Clinical Trial
Public title
The effect of tattoo markers in marking the Bladder tumor site
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Bladder tumor patients who were referred for the first time (primary).
The size of the tumor is less than 3 cm
The tumor is salitary
Non metastatic tumor
High grade tumor
Informed consent from patients
Exclusion criteria:
Multifocal tumor
The volume of the patient's bladder should be small
The tumor is recurrent
The patient is not a candidate for reTURBT
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
For randomization, the balanced block randomization method is used to generate blocks with a size of 4. Intervention group A and control group B have been determined. According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the Sealdenvelop online site, the generated sequence will be available to a technician outside the research team. blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected, and the type of patient group is informed to the research team through a trained technician. Based on the randomly selected envelope, the patient is placed in the group (Patients who have markings with tattoo ink) or (Patients who do not have markings with tattoo ink).
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is a single-blind, randomized clinical trial study. The participant will not know that he will be in the intervention group (Re TURBT candidate patients with tattoo ink) or the control group (Re TURBT candidate patients who do not have markings with tattoo ink).
India ink or tattoo (an inert, colloidal suspension of carbon particles that has been used safely during colonoscopies for decades to mark the location of relevant lesions).
Determining the success rate and feasibility of identifying the location of the tumor using of tattoo ink
Timepoint
Four to six weeks after TURBT
Method of measurement
The necessary pathological and cytological results (complete blood test, keratin, etc.)
Secondary outcomes
empty
Intervention groups
1
Description
(Re-TURBT candidate patients who have tattoo ink marking for safe and successful marking of lesions in Re-TURBT patients with bladder tumor for the first time. Tattooing will be done at intervals of 1 to 2 cm, approximately 1 cm from the outer edge of the lesion, with sufficient depth (deep muscle layer) under cystoscopy guidance.
Category
Diagnosis
2
Description
Control group: (Patients who are candidates for Re TURBT who do not have markings with tattoo ink)
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St., Tehran, Iran .
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
Sixth Floor, Central University, Quds Ave., Keshavarz Boulevard, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
تهران
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Demographic information anonymously
When the data will become available and for how long
One year after publication
To whom data/document is available
Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560 mkaghamir@tums.ac.ir
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.