Comparison of therapeutic outcomes and complications of Overnight stay after Percutaneous Nephrolithotomy versus ordinary admission (3 days) in patients with renal stones: a randomized clinical trial
The aim of this study is to evaluate the safety and result of Percutaneous NephroLithotomy (PCNL) during one night stay in patients undergoing PCNL surgery without complications
Design
Clinical trial with control group, with parallel groups, one blind, randomized
Settings and conduct
Patients undergoing Percutaneous NephroLithotomy PCNL in Tehran Labafinejad Hospital; single blind (the participant has no information about the time of discharge)
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Acceptable anesthesia risk (ASA class< 3);
No Single kidney or renal insufficiency;
No Pyonephrosis or infected stone ;
Insignificant residual stone (<5mm);
No intra or postoperative complications;
≤ 1 unit blood transfusion during operation;
< 3 units hemoglobin decrease in the next morning.
Non inclusion Criteria:
Taking anti-coagulants;
Urinary tract infection;
High creatinine.
Intervention groups
Group 1: patients will be discharged after removing foley catheter, ureteral stent, and nephrostomy tube after a night stay. In group 2 : the nephrostomy tube will be removed on the second postoperative day. The patient will be discharged on the third postoperative day after removing foley and ureteral stent.
Main outcome variables
Patients' non complicated discharge after one day
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171228038115N1
Registration date:2018-05-25, 1397/03/04
Registration timing:retrospective
Last update:2018-05-25, 1397/03/04
Update count:0
Registration date
2018-05-25, 1397/03/04
Registrant information
Name
Hormoz Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3221 2001
Email address
hormozkarami@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2013-10-23, 1392/08/01
Actual recruitment start date
2013-06-22, 1392/04/01
Actual recruitment end date
2014-01-05, 1392/10/15
Trial completion date
empty
Scientific title
Comparison of therapeutic outcomes and complications of Overnight stay after Percutaneous Nephrolithotomy versus ordinary admission (3 days) in patients with renal stones: a randomized clinical trial
Public title
Comparison of therapeutic outcomes and complications of Overnight stay versus ordinary admission (3 days) after Percutaneous Nephrolithotomy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Acceptable anesthesia risk (ASA class< 3)
No Single kidney or renal insufficiency
No Pyonephrosis or infected stone
Insignificant residual stone (<5mm)
No intra or postoperative complications
≤ 1 unit blood transfusion during operation
< 3 units hemoglobin decrease in the next morning
Exclusion criteria:
Taking anti-coagulants
UTI
High creatinine
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Sample size
Target sample size:
300
Actual sample size reached:
210
Randomization (investigator's opinion)
Randomized
Randomization description
Using block randomization method, the patients will be categorized into two groups. Each block contains 4 components named "A" and "B" representing two methods of interest. Based on the permutation of the words (A and B), six blocks are defined:
1: AABB
2: BBAA
3: ABBA
4: BAAB
5: ABAB
6: BABA.
We will use numbers 1 to 6 from random numbers table to choose a block randomly. Numbers 0, 7, 8, and 9 will be ignored.
Blinding (investigator's opinion)
Single blinded
Blinding description
The participant has no information about the time of discharge
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
9th Boostan ,Pasdaran St,Tehran.
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2013-03-12, 1391/12/22
Ethics committee reference number
911222/4
Health conditions studied
1
Description of health condition studied
Stone Kidney
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
hemoglobin change
Timepoint
1-3 days
Method of measurement
Blood test
2
Description
creatinine change
Timepoint
1-3 days
Method of measurement
Blood test
3
Description
Patients' non complicated discharge after one day
Timepoint
1day
Method of measurement
Kidney, ureters and bladder x-ray (KUB), renal ultrasonography, checke hemoglobin (Hb) and creatinine (Cr), sodium and potassium .
Secondary outcomes
1
Description
Fever
Timepoint
first 24 hour
Method of measurement
thermometer
2
Description
residual stone
Timepoint
first 24 hour
Method of measurement
Sonography
Intervention groups
1
Description
Intervention group: In patients receiving general or spinal anesthesia, 5-French Ureteral Stent was placed on the affected side through cystoscopy. Then in dorsal lumbotomy position or supine position, pyelocaliceal system and stones were determined by contrast and fluoroscopy or ultrasonography, and a Chiba needle was passed into the selected calyces of the kidney. A guidewire was passed through the needle into the pelvis. Over the guidewire the dilatators and then working element (26-30F) were placed, and by using normal saline solution as irrigating solution, 24 French nephroscope was passed inside Amplatz sheaths and the stone(s) were crushed by pneumatic lithotripsy and removed with grasper. Finally, a nephrostomy tube was fixed in the kidney. The size of the nephrostomy tube was 20-24F depending on bleeding during the procedure,extent of manipulation, and surgeon’s preferences. If a considerable amount of the stone residue (>5mm) was observed on control fluoroscopy at the end of the procedure, the patient was excluded from the study. All the procedures were carried out by a surgeon.In group was discharged after extracting Foley catheter, ureter stent, and nephrostomy tub
Category
Treatment - Surgery
2
Description
Control group: In patients receiving general or spinal anesthesia, 5-French Ureteral Stent was placed on the affected side through cystoscopy. Then in dorsal lumbotomy position or supine position, pyelocaliceal system and stones were determined by contrast and fluoroscopy or ultrasonography, and a Chiba needle was passed into the selected calyces of the kidney. A guidewire was passed through the needle into the pelvis. Over the guidewire. The dilatators and then working element (26-30F) were placed, and by using normal saline solution as irrigating solution, 24 French nephroscope was passed inside Amplatz sheaths and the stone(s) were crushed by pneumatic lithotripsy and removed with grasper. Finally, a nephrostomy tube was fixed in the kidney. The size of the nephrostomy tube was 20-24F depending on bleeding during the procedure, extent of manipulation, and surgeon’s preferences. If a considerable amount of the stone residue (>5mm) was observed on control fluoroscopy at the end of the procedure, the patient was excluded. The nephrostomy tube was removed on the second postoperative day. The patient was discharged on the third postoperative day after removing the Foley and the ureteral sten. Nephrostomy tube was extracted the day after surgery and the patient was discharged on the third postoperative day after extracting Foley catheter and ureter stent.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Labafinejad Hospital
Full name of responsible person
Hormoz Karami
Street address
9th Boostan, Pasdaran St,Tehran Province
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2254 9039
Email
hormozkarami@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Deputy Research and Technology
Street address
9th Boostan, Pasdaran St,Tehran Province
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2243 1920
Email
hormozkarami@yahoo.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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hormoz Karami
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
9th Boostan, Pasdaran St, Tehran Province
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2254 9039
Email
r.bandari2314@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Hormoz Karami
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
9th Boostan, Pasdaran St, Tehran city
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2254 9039
Email
r.bandari2314@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hormoz Karami
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Urology
Street address
Department of Urology, Rahnamon Hospital, Farrokhi street,Yazd
City
Yazd
Province
Yazd
Postal code
1983969411
Phone
+98 35 3221 2001
Fax
Email
hormozkarami@ssu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available