Comparison of Laparoscopic Pyelolithotomy versus Percutaneous Nephrolithotomy for the Treatment of patients with Staghorn Kidney Stones ; a randomized clinical trial
1- Comparison of success rate of laparoscopy versus percutaneous surgery for kidney staghorn stone treatment
Design
Single-blinded randomized clinical trial consisting of 68 patients, will be divided into two arm parallel group , randomization will be done by random allocation software
Settings and conduct
This study is a parallel randomized clinical trial study. Patients with staghorn stones (which are one-piece or maximum two-piece with an extra-renal pelvis) who are candidates for elective surgery will enter in our study. Randomization will be done through permuted block randomization to be randomly divided into pyelolithotomy and PCNL groups.
After completing the questionnaire, which includes the patient's demographic and paraclinical information, all variables examined during and after surgery will be completed according to questinnaire. Finally, the data will be entered in SPSS . the analyst is not aware about the type of patient group so this study is designed as Single Blind clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Patients with One-Piece or Two-piece Stag-Horn Stone with large Extra-Renal part
Exclusion criteria : Patients who do not have consent for open surgery.
Intervention groups
34 patients will undergo laparoscopic pyelolithotomy and 34 patients will undergo percutaneous nephrolithotomy
Main outcome variables
stone free rate, serum creatinine before and after surgery, duration of surgery, rate of hemoglobin loss, duration of hospitalization, complications after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180625040232N5
Registration date:2020-08-06, 1399/05/16
Registration timing:retrospective
Last update:2020-08-06, 1399/05/16
Update count:0
Registration date
2020-08-06, 1399/05/16
Registrant information
Name
Saman Farshid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9931
Email address
farshid.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-03, 1399/01/15
Expected recruitment end date
2020-07-20, 1399/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Laparoscopic Pyelolithotomy versus Percutaneous Nephrolithotomy for the Treatment of patients with Staghorn Kidney Stones ; a randomized clinical trial
Public title
Evaluation of laparoscopic surgery success versus percutaneous surgery for kidney staghorn stone
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with One-Piece or Two-piece Stag-Horn Stone with large Extra-Renal part
Absence Of active Urinary Tract Infection
Absence Of coagulopathy
Age 18-65 years old
HB > 10 mg/dl
ASA physical status classification 1 or 2
Exclusion criteria:
Absence of consent for entering the study
Absence of acceptance for the probability open surgery in each group of studies
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will conduct based on permuted block randomization method. Each block will have capacity for 4 subjects; it means we will have 17 blocks. Then, within each block, subjects will be randomly assigned to laparoscopy or percutaneous procedure. Random assignment will be done using a random number table
Blinding (investigator's opinion)
Single blinded
Blinding description
Given that the surgical technique should be reported to patients preoperatively , the researcher and patients participating in the study should be aware of the surgical technique, but the analyst is unaware of which patient belongs to which intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ٍEthics committe of Shahid Labbafinejad Medical Center and Urology and Nephrology Research Center,Sh
ِDuring Surgery , 2weeks after surgery in outpatient visit at hospital clinic
Method of measurement
Checklist
Secondary outcomes
1
Description
Pain severity after surgery
Timepoint
After surgery intervention during Admission
Method of measurement
According to Visual Analogue Scale Questionnaire
2
Description
Hemoglobin Drop After Surgery
Timepoint
Before and after surgery intervention
Method of measurement
CBC-Diff Test before and after surgery
3
Description
Surgery Time
Timepoint
During surgery intervention
Method of measurement
Recording the surgery time after anesthesia induction
4
Description
Post Operation Complication
Timepoint
Post operation complication
Method of measurement
Complication Check list
5
Description
Creatinine
Timepoint
Before and after surgery intervention
Method of measurement
Blood sampling
6
Description
Number of hospitalized day
Timepoint
Once on the discharge time
Method of measurement
Patient's file
Intervention groups
1
Description
Intervention group: Patients with one piece or maximum two piece Stag Horn Stone with extra renal pelvis who will undergo per-cutaneous nephrolithotomy
Category
Treatment - Surgery
2
Description
Intervention group: Patients with one piece or maximum two piece Stag Horn Stone with extra renal pelvis who will undergo laparoscopic Pyelolithotomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Labbafinejad Hospital
Full name of responsible person
Mohamad Hossein Soltani
Street address
Labbafinejad Hospital , Boostan 9 Paydarfard Ave.,Pasdaran Blvd , Tehran
City
تهران
Province
Tehran
Postal code
1666663111
Phone
+98 21 23601
Email
mhsoltani60@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Shabnam Golshan
Street address
No 103, Boostan 9 Eslami Ave.,Pasdaran Blvd.,Tehran
City
تهران
Province
Tehran
Postal code
1666663111
Phone
+98 21 2256 7222
Email
Sh.Golshan2@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Khomeini Hospital , Ershad Blvd ,Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3345 7287
Email
samanf63@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Khomeini Hospital , Ershad Blvd ,Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3345 7287
Email
samanf63@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Saman Farshid
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Imam Khomeini Hospital , Ershad Blvd ,Urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3345 7287
Email
Samanf63@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Any information without the need for patients' names will be available
When the data will become available and for how long
Six months after publication
To whom data/document is available
Faculty members of medical universities
Under which criteria data/document could be used
For research purposes
From where data/document is obtainable
Email to Dr. Saman Farshid farshid.s@umsu.ac.ir
What processes are involved for a request to access data/document