Comparison of the results and complications Laparoscopic removal of renal cysts with percutaneous drainage and sclerosing injections
Design
The study is a randomized, community-based, and pragmatic clinical trial consisting of 80 patients in 2 parallel groups with double-blind design
Settings and conduct
This study will be carried out at Tabriz Imam Hospital in a two-blind manner
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with a simple kidney cyst in the upper part,Patients with a simple kidney cyst with a size of more than 4 cm . Exclusion criteria: patients with polycystic, kidney Patients with infectious renal cysts, patients with cystic tumors, Patients with coagulopathy
Intervention groups
Intervention group: Injection of sclerosant into the cyst, Control group: Renal cyst removal by laparoscopic surgery
Main outcome variables
Duration of intervention,The recurrence rate of Kidney cyst,The rate of complications after the intervention
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231127060199N1
Registration date:2024-01-15, 1402/10/25
Registration timing:prospective
Last update:2024-01-15, 1402/10/25
Update count:0
Registration date
2024-01-15, 1402/10/25
Registrant information
Name
Masoud ghofrani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
drmasoudghofrani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-08-20, 1403/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the results and complications Laparoscopic removal of renal cysts with percutaneous drainage and sclerosing injections
Public title
Comparison of the complications of renal cysts with laparoscopic removal and percutaneous cyst drainage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with a simple kidney cyst in the upper part of the kidney
Patients with a simple kidney cyst with a size of more than 4 cm
Exclusion criteria:
patients with polycystic kidney
Patients with infectious renal cysts
patients with cystic tumors
Patients with coagulopathy
Age
From 30 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by last digit of the patient's file number . Even number for group laparoscopic removal of renal cysts and odd number for percutaneous drainage and sclerosing injections
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting study groups based on last digit of the patient's file number. 1 and 2 labels were assigned to the target group by the secretary. Then, the patients will be intervened by the researcher in the operating room in the case group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz Medical School
Street address
No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Approval date
2023-06-12, 1402/03/22
Ethics committee reference number
IR.TBZMED.REC.1402.220
Health conditions studied
1
Description of health condition studied
Simple kidney cysts
ICD-10 code
N28.1
ICD-10 code description
Cyst of kidney, acquired
Primary outcomes
1
Description
Duration of intervention
Timepoint
From the start of surgery to the end of surgery
Method of measurement
period of time
2
Description
Duration of admitted
Timepoint
From admission to discharge
Method of measurement
Hospitalization day
Secondary outcomes
1
Description
The rate of complications after the intervention
Timepoint
At 3th,6th months after surgery
Method of measurement
Physical examination
2
Description
he recurrence rate of Kidney cyst
Timepoint
At 3th,6th months after surgery
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Intralesional Bleomycin Sclerotherapy: In patients in this group, injections are performed by one person and under ultrasound guide in the operating room and under general anesthesia. After a general examination of the cyst with examination and ultrasound in the operating room, first the fluid contents of the cysts are repeatedly emptied under the ultrasound guide by a 10 cc syringe and needle number 21. While the needle head is in the same place inside the cyst and the control is done by sono, the sclerosing substance is injected at the site. The required dose is 0.5 units per kilogram of body weight. The maximum amount of injection to prevent possible complications is 10 units of sclerosing material.
Category
Treatment - Surgery
2
Description
Intervention group: Renal cyst removal by laparoscopic surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Urology Ward, Imam Reza Hospital,
Full name of responsible person
Alireza Farshi
Street address
Golgasht ave,imam reza Hhospital
City
Tabriz
Province
East Azarbaijan
Postal code
5166614756
Phone
+98 916 276 3495
Email
dr.ramezanireza70@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Samiee
Street address
Golgasht Street. Research and Technology, University of Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 914 117 0855
Email
hajebrahimis@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?