Comparison between classic percutaneous nephrolithotomy (PCNL) with nephrostomy free PCNL and tubeless PCNL on length of hospitalization and analgesic usage in patients with renal stones candidated for PCNL
Objective:
Comparison between classic percutaneous nephrolithotomy ( PCNL) and nephrostomy free PCNL and tubeless PCNL on length of hospitalization and analgesic usage in patients with renal stones candidated for PCNL.
Design:
Randomized, not blinded, single center.
Setting and Conduct:
Patients will be divided in three groups randomly(senary batches): classic group, nephrostomy free group and tubeless group. Then length of hospitalization and amount of analgesic usage in patients will be checked.
Participants including major eligibility criteria:
Inclusion criteria: Each patient with renal stones who is referred to Shahid Beheshti hospital and candidated for percutaneous nephrolithotomy between 2012-2014.
Exclusion criteria: Significant residual stones requiring Re-PCNL.
Excessive bleeding during surgery and after surgery that nephrostomy tube will be fixed. Serious damage to the pyelocalyceal system that double J will be placed.
Target sample size:
Sixty patients
Interventions:
Using no nephrostomy and ureter catheter after surgery in the interventional groups
Main outcome variables:
Patient's hospital stay,
Patient's analgesic usage.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201204169485N1
Registration date:2012-12-12, 1391/09/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-12, 1391/09/22
Registrant information
Name
Hamid Shayaninasab
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1822 9571
Email address
shayaninasab_h@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Hamedan University of Medical Sciences
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2014-03-20, 1392/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between classic percutaneous nephrolithotomy (PCNL) with nephrostomy free PCNL and tubeless PCNL on length of hospitalization and analgesic usage in patients with renal stones candidated for PCNL
Public title
Comparison between kidney stone surgery through the skin, without nephrostomy tube method and without any tube method versus classic method.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Each patient with renal stones who is referred to Shahid Beheshti hospital and candidated for percutaneous nephrolithotomy between 2012-2014.
Exclusion criteria: Significant residual stones requiring Re-PCNL.
Excessive bleeding during surgery and after surgery that nephrostomy tube will be fixed. Serious damage to the pyelocalyceal system that double J will be placed.
Age
From 10 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
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, Hamedan University of Medical Sciences
Street address
Shahid Fahmide Blvd
City
Hamedan
Postal code
Approval date
2012-03-04, 1390/12/14
Ethics committee reference number
د/پ/16/35/9/4583
Health conditions studied
1
Description of health condition studied
Renal calculus
ICD-10 code
N20.0
ICD-10 code description
Nephrolithiasis NOS. Renal calculus or stone. Staghorn calculus. Stone in kidney.
Primary outcomes
1
Description
Patient's hospital stay
Timepoint
After discharge
Method of measurement
Length of hospitalization
2
Description
Patient's analgesic usage
Timepoint
After discharge
Method of measurement
Milligram amount of analgesic drug using by patient
Secondary outcomes
1
Description
Fever after 24 hours of surgery
Timepoint
24 hours after surgery
Method of measurement
By using thermometer
Intervention groups
1
Description
Control group:
1. Access to a suitable calyce
2. Dilatation
3. Intracorporeal lithotripsy
4. Fixing a nephrostomy tube
5. Placing a ureter catheter
Category
Treatment - Surgery
2
Description
Interventional group 1:
All procedures are included like classic surgery except stage IV; Which means nephrostomy tube will not be fixed for these patients after surgery.
Category
Treatment - Surgery
3
Description
Interventional group 2:
All procedures are included like classic surgery, except last two stages; Which means patients will not have nephrostomy tube or ureter catheter after surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamedan
Full name of responsible person
Hamid Shayani Nasab
Street address
Shahid Beheshti Hospital, Eram Blvd, Qaem Square, Shahid Fahmide Blvd
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Hamedan University of Medical Sciences
Full name of responsible person
Heydar Tavilaani
Street address
Vice Chancellor for Research, Hamedan University of Medical Sciences. Shahid Fahmide Blvd
City
Hamedan
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, Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Hamid Shayani Nasab
Position
Endourologist / Assistant Professor of University
Other areas of specialty/work
Street address
Medical Faculty, Hamedan University of Medical Sciences, Shahid Fahmide Blvd
City
Hamedan
Postal code
Phone
+98 81 1822 4864
Fax
Email
Shayaninasab_h@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hamid Shayani Nasab
Position
Endourologist/ Assistant Professor of University
Other areas of specialty/work
Street address
Medical Faculty, Hamedan University of Medical Sciences, Shahid Fahmide Blvd
City
Hamedan
Postal code
Phone
+98 81 1822 4864
Fax
Email
Shayaninasab_h@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hamid Shayani Nasab
Position
Endouorologist/ Assistant Professor of University
Other areas of specialty/work
Street address
Medical Faculty, Hamedan University of Medical Sciences, Shahid Fahmide Blvd
City
Hamedan
Postal code
Phone
+98 81 1822 4864
Fax
Email
Shayaninasab_h@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)