Objectives: To assess the effect of single-step alcohol injection and maintenance of drainage catheter on treatment of simple renal cysts.
Design: A before-after clinical trial.
Setting and conduct: The eligible patients with simple renal cysts who will refer to Shahid Beheshti Hospital during the study period will be enrolled into the trial.
Inclusion criteria: Age of 30 to 65 years; simple renal cyst with a size of larger than 4 cm with signs and symptoms such as flank pain or abdominal pain or hematuria or high blood pressure or pressure effect on ureter or pelvic.
Exclusion criteria: Autosomal dominant renal polyp cystitis; infectious kidney cysts; cystic tumors; previous treated cysts; coagulopathy.
Intervention group: Single dose injection of ethanol 95% intra cyst up to 100 ml and maintenance of drainage catheter for 5 days.
Control group: In comparison with before intervention.
Primary outcome: Assessing renal cyst 3 and 6 months after treatment using sonography.
Randomization: This is a before after trial without randomization
Blinding: Not possible.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201710309014N198
Registration date:2017-10-31, 1396/08/09
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-10-31, 1396/08/09
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-06-09, 1395/03/20
Expected recruitment end date
2017-06-10, 1396/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of single-step alcohol injection and maintenance of drainage catheter on treatment of simple renal cysts: a before-after clinical trial
Public title
Effect of single-step alcohol injection and maintenance of drainage catheter on treatment of simple renal cysts
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age of 30 to 65 years; simple renal cyst with a size of larger than 4 cm with signs and symptoms such as flank pain or abdominal pain or hematuria or high blood pressure or pressure effect on ureter or pelvic.
Exclusion criteria: Autosomal dominant renal polyp cystitis; infectious kidney cysts; cystic tumors; previous treated cysts; coagulopathy.
Age
From 30 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Randomization: This is a before after trial without randomization
Blinding: Not possible.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Approval date
2016-06-07, 1395/03/18
Ethics committee reference number
IR.UMSHA.REC.1395.9
Health conditions studied
1
Description of health condition studied
Simple renal cysts
ICD-10 code
N28.1
ICD-10 code description
Cyst of kidney, acquired
Primary outcomes
1
Description
Assessing renal cyst
Timepoint
3 and 6 months after treatment
Method of measurement
Using sonography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Single dose injection of ethanol 95% intra cyst up to 100 ml and maintenance of drainage catheter for 5 days.
Category
Treatment - Drugs
2
Description
Control group: In comparison with before intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr Mohsen Alemi
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology, 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
Shahid Beheshti Hospital
Full name of responsible person
Dr Mohsen Alemi
Position
Urologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
mohsenalemi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti Hospital
Full name of responsible person
Dr Mohsen Alemi
Position
Urologist
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Eram Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0283
Fax
Email
mohsenalemi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)