Comparison of efficacy and complications of transurethral lithotripsy (TUL) with Holmium laser versus extracorporeal shockwave lithotripsy (ESWL) in treatment of upper ureteral stones.
Background & Aim: our goal in this study is comparing efficacy and complications of transurethral lithotripsy (TUL) with Holmium laser versus extracorporeal shockwave lithotripsy (ESWL) in the treatment of upper ureteral stones. Materials and Methods: Sixty patients with upper ureter stones with size of 5-15 mm that refer to Shahid Beheshti hospital of Yasuj that will be candidate for Lithotripsy after taking informed consent form and approval of ethics committee randomly assigned in two groups. In the first group ESWL will be done in supine position with Dornier Delta 2 machine with ultrasound Shock Waves by standard methods. After lithotripsy patients observed for two hours and patients’ satisfaction will be checked by Beck scale. Then, in absence of any Complications patients will be discharged with medication order and outpatient follow up. In second groups after anesthesia by standard methods patients situated in lithotomy position and lithotripsy will be done with flexible ureteroscopy and Holmium laser with fluoroscopic guidance by standard methods. After operation, patients will be admitted and the next day in absence of any Complications they discharged with medication and outpatient follow up .in both groups two weeks later again patients visit and KUB with ultrasonography was done for efficacy of operation and complications and results again checked and data recorded and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201501301323N8
Registration date:2015-07-24, 1394/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-24, 1394/05/02
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
Vice chancellor for research, Yasuj University of Medical Sciences
Expected recruitment start date
2014-07-23, 1393/05/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of efficacy and complications of transurethral lithotripsy (TUL) with Holmium laser versus extracorporeal shockwave lithotripsy (ESWL) in treatment of upper ureteral stones.
Public title
Holmium laser versus extracorporeal shockwave lithotripsy (ESWL) in treatment of upper ureteral stones
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 15 years old suffering from upper ureteral stone; stone size between 6-15 mm.
Exclusion criteria: presence of coagulopathy; presence of neuropathy; stone size more than 15mm in ureter; presence of active infection; presence of azotemia; uncontrolled hypertension; hypersensitivity to narcotic drugs; pregnancy any contraindication for general anesthesia.
Age
From 15 years old to 99 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Postal code
Approval date
2013-08-12, 1392/05/21
Ethics committee reference number
25/17/1391/پ
Health conditions studied
1
Description of health condition studied
Calculus of kidney and ureter
ICD-10 code
N20.2
ICD-10 code description
Calculus of kidney and ureter
Primary outcomes
1
Description
Crushing of ureteral stones smaller than 15 milimeter
Timepoint
Two weeks after the lithotripsy and ureteroscopy
Method of measurement
KUB and Ultrasonography
Secondary outcomes
1
Description
Development of unwanted complications
Timepoint
During operation till two weeks later
Method of measurement
Observatin and examination and ultrasonography and imaging
Intervention groups
1
Description
Procedures will be done in supine position under fluoroscopic guidance by Dornier Delta 2 lithotriptor with standard technique in 12 kilovoltage power increased to 18 KV during 10 minutes until intolerance of patients or giving maximum shock of 3000.
Category
Treatment - Devices
2
Description
Lithotripsy in lithotomy position with flexible ureteroscope and Holmium laser lithotriptor.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Beheshti hospital
Full name of responsible person
Sadrollah Mehrabi
Street address
Shaheed Beheshi hospital, Montazeri street, Yasuj
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research vice chancellor
Full name of responsible person
Dr Mehdi Akbartabar
Street address
Mottahari street,Research vice chancelor, Yasuj University of Medical Sciences, ,
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research vice chancellor
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
Faculty of Medicine,Yasuj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
professor, Fellowship of endourology and laparoscopy
Other areas of specialty/work
Street address
No.22, Bahonar street, Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3334 6070
Fax
Email
sadrollahm@yahoo.com; dr.mehrabi@yums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of medicine,Yasuj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
professor, Fellowship of endourology and laparoscopy
Other areas of specialty/work
Street address
No.22, Bahonar street,Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3334 6070
Fax
Email
sadrollahm@yahoo.com; dr.mehrabi@yums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of medicine, Yasuj University of Medical Sciences
Full name of responsible person
Sadrollah Mehrabi
Position
Professor of urology department, Fellowship of endourology and laparoscopy
Other areas of specialty/work
Street address
No.22, Bahonar street, Yasuj, Iran
City
Yasuj
Postal code
Phone
+98 74 3334 6070
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)