Evaluation of the Clinical Results and Complications of Retroperitoneal Laparoscopic Surgery of Pelvis and Ureter Stones and its Comparison with Open Surgery
The aim of present study is to evaluate clinical results and complications of retroperitoneal laparoscopic surgery of pelvis and ureter stones and its comparison with open surgery. In a single center clinical trial study, 70 patients with pelvis and ureter stones who referred to Imam Reza Educational Medical Center of Tabriz University of Medical Sciences for doing lithotripsy surgery, will include the study and will evaluate. Patients will allocate in two groups based on the patient's desire. Inclusion criteria are middle and upper part of the ureter and the pelvic stone, and stone over 15 mm. Also exclusion criteria are multiple stones, and distal ureter stones. In first group patients (35 patients) will underwent laparoscopic retroperitoneal surgery and patients in the second group (35 patients) will underwent open stone surgery. Success in removing stones as the primary outcome variable and the incidence of postoperative complications as secondary outcome variables will be evaluate up to two weeks after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013031312728N2
Registration date:2017-07-30, 1396/05/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-07-30, 1396/05/08
Registrant information
Name
Sakineh Hajebrahimi
Name of organization / entity
Urology Department, Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7328
Email address
ebrahimis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University Of Medical Sciences.
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Clinical Results and Complications of Retroperitoneal Laparoscopic Surgery of Pelvis and Ureter Stones and its Comparison with Open Surgery
Public title
Retroperitoneal Laparoscopic Surgery of Pelvis and Ureter Stones and its Comparison with Open Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: middle and upper part of the ureter and the pelvic stone; stone over 15 mm.
Exclusion criteria: multiple stones; distal ureter stones.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Tabriz University of Medical Sciences.
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Postal code
Approval date
2017-04-24, 1396/02/04
Ethics committee reference number
IR.TBZMED.REC.1396.56
Health conditions studied
1
Description of health condition studied
Urinary stone
ICD-10 code
N20.1
ICD-10 code description
Calculus of ureter
Primary outcomes
1
Description
Success in removing stones
Timepoint
During surgery
Method of measurement
Clinical evaluation
Secondary outcomes
1
Description
Surgical complications
Timepoint
Up to two weeks after surgery
Method of measurement
Clinical evaluation
Intervention groups
1
Description
In intervention group: Patients will undergo retroperitoneal laparoscopic surgery.
Category
Treatment - Surgery
2
Description
In control group: Patients will undergoing open surgery of ureter and pelvic stones.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam-Reza Hospital of Tabriz University of Medical Sciences
Full name of responsible person
Dr Rasoul Jafari
Street address
Imam-Reza Hospital of Tabriz University of Medical Sciences, Daneshgah Street, Tabriz, Eastern Azerbaijan, Iran.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences.
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Deputy of Research and Technology, Central Building of Number Two, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Rasoul Jafari
Position
Resident of Urology
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3335 7310
Fax
Email
ra.jafari009@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences.
Full name of responsible person
Dr Sakineh Hajebrahimi
Position
Subspecialty of Urology
Other areas of specialty/work
Street address
Faculty of Medicine, Tabriz University of Medical Sciences, Daneshgah Street, Tabriz.
City
Tabriz
Postal code
Phone
+98 41 3335 7310
Fax
Email
ebrahims@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)