Protocol summary

Study aim
Comparison of efficacy and complications of Holmium Laser and Pneumatic Lithotripsy in treatment of adult patients with ureteral stones sized 6-20 millimeter
Design
In this non blinded randomized parallel clinical trial, 80 Patients are allocated randomly with double block allocation in one of the two groups (pneumatic or holmium laser lithotripsy) by help of sealed envelope and will receive the intervention of that group.
Settings and conduct
Patients referred to Shahid Beheshti hospital of Yasuj with ureteral stones less than 10 mm are divided into one of two groups. In the first group (pneumatic), ureteroscopy is performed in the lithotomy position, and after entering the ureter, litholapaxy is performed by standard method . In second group(holmium laser) similar to first group ureteroscopy is performed and lithotripsy will be done by laser fiber with standard method .Two weeks later, ultrasound is performed and the success of the treatment is measured by the absence of stones or the presence of residual stones. The duration of the operation and other complications are checked and recorded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age more than18 years old , ureteral stone less than 20 millimeter,having informed consent Exclusion criteria:Uncontrolled coagulopathy , Pregnancy, active urinary tract infection
Intervention groups
In the first group (pneumatic), after spinal or general anesthesia, ureteroscopy is performed in the lithotomy position, and after entering the ureter, litholapaxy is performed by standard method and if necessary, double J is placed. In second group(holmium laser) similar to first group after spinal or general anesthesia, ureteroscopy is performed and after observing stone lithotripsy will be done by laser fiber with standard method
Main outcome variables
Change in the size and passage of stones ,operation time

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20081011001323N31
Registration date: 2023-06-10, 1402/03/20
Registration timing: registered_while_recruiting

Last update: 2023-06-10, 1402/03/20
Update count: 0
Registration date
2023-06-10, 1402/03/20
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and complications of Holmium Laser and Pneumatic Lithotripsy in treatment of adult patients with ureteral stones sized 6-20 mililimeter
Public title
Holmium Laser versus Pneumatic Lithotripsy in treatment of patients with ureteral stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 15 years old suffering from ureteral stone stone size between 6-20mm. Having informed consent form
Exclusion criteria:
presence of coagulopathy pregnancy presence of active infection azotemia uncontrolled hypertension hypersensitivity to narcotic drugs any contraindication for anesthesia.
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
According to the law of random allocation, first 40 balls A = pneumatic and 40 balls B = holmium laser are placed through the conduit into a dark container and then the balls are randomly removed from the container without replacement and the created sequence is recorded. With the referral of each patient, one of the envelopes will be randomly selected by the patients and will be introduced as a study group. The stratification approach is not used. Concealment will not take place in the study.
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
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Mottahari srteet, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2023-04-19, 1402/01/30
Ethics committee reference number
R.YUMS.REC.1402.017

Health conditions studied

1

Description of health condition studied
ureteral stones
ICD-10 code
N20.9
ICD-10 code description
Urinary calculus, unspecified

Primary outcomes

1

Description
passage of ureteral stones with sizes from 5 to 10 millimeters
Timepoint
Two weeks after start of treatment
Method of measurement
Perform KUB and sonography and patient report

Secondary outcomes

1

Description
operation time
Timepoint
During operation
Method of measurement
With recording time from start of anesthesia till end of operation

Intervention groups

1

Description
Intervention group: In the first group (holmium laser) after spinal anesthesia, in lithotomy position uretroscopy and lithotripsy will be done by laser fiber and if necessary double j will be inserted.
Category
Treatment - Surgery

2

Description
Control group: In the second group (pneumatic) after spinal anesthesia, in lithotomy position uretroscopy and lithotripsy will be done by pneumatic lithotriptor and if necessary double j will be inserted.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Sadrolleh Mehrabi
Street address
Shahid Beheshti hospital, Montazeri Street, Yasuj
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 4721
Email
sadrollahm@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Amir hossain dosti motlagh
Street address
Deputy of research, Yasuj University of Medical Sciences,, Motahari St
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6074
Email
amirhosseindoustimotlagh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Professor, Chairman of Urology Department, Yasuj University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Shahid Mofateh clinic, Montazeri street,Yasuj,Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 1812
Email
sadrollahm@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Professor, Chairman of Urology Department, Yasuj University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Shahid Mofateh clinic, Montazeri street,Yasuj,Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 1812
Email
sadrollahm@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Professor, Chairman of Urology Department, Yasuj University of Medical Sciences
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Yasuj University of Medical Sciences, Mottahari Street, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 9297
Email
dr.mehrabi@yums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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