To assess the effect of tubeless percutaneous nephrolithotomy with and without suture on clinical outcomes
Design
This is a single-blind randomized clinical trial, phase II, in which 50 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients who are a candidate for percutaneous nephrolithotomy referring to the Beheshti Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be single-blinded so that the physician examining the patients will be aware of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 75 years,
Candidate for percutaneous nephrolithotomy,
Having stones more than one centimeter in diameter in the lower calyx,
Having stones with a diameter of more than two centimeters in the upper and middle calyx and pelvis,
Having stones more than one centimeter in diameter in the ureter,
Exclusion criteria:
History of previous surgery of renal stone
Intervention groups
Intervention group:
Tubeless percutaneous nephrolithotomy without any suture on the location of surgery
Control group:
Tubeless percutaneous nephrolithotomy with one or two sutures on the location of surgery
Main outcome variables
Primary outcome:
The amount of bleeding, leakage of urine from the surgical site, mean duration of hospitalization a
Secondary outcome:
Occurrence of abscess
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N396
Registration date:2021-05-15, 1400/02/25
Registration timing:prospective
Last update:2021-05-15, 1400/02/25
Update count:0
Registration date
2021-05-15, 1400/02/25
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of tubeless percutaneous nephrolithotomy with and without suture on clinical outcomes: a single-blind randomized clinical trial
Public title
Effect of percutaneous nephrolithotomy with and without suture on clinical outcomes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 75 years,
Candidate for percutaneous nephrolithotomy,
Having stones more than one centimeter in diameter in the lower calyx,
Having stones with a diameter of more than two centimeters in the upper and middle calyx and pelvis,
Having stones more than one centimeter in diameter in the ureter,
Exclusion criteria:
History of previous surgery of renal stone
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare 50 sheets and write "intervention" on 25 sheets and "control" on others. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The physician who will examine the patients will not be aware of the intervention. Thus, the trial will be run as single-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2021-05-02, 1400/02/12
Ethics committee reference number
IR.UMSHA.REC.1400.118
Health conditions studied
1
Description of health condition studied
Kidney stone
ICD-10 code
N20.0
ICD-10 code description
Calculus of kidney
Primary outcomes
1
Description
The amount of bleeding during surgery
Timepoint
After end of surgery
Method of measurement
By counting the gases used
2
Description
Leakage of urine from the surgical site
Timepoint
In the first 24 hours after surgery
Method of measurement
With clinical examination
3
Description
Mean duration of hospitalization
Timepoint
After surgery
Method of measurement
Based on medical records
Secondary outcomes
1
Description
Occurrence of abscess at the surgical site
Timepoint
One month after surgery
Method of measurement
With clinical examination
Intervention groups
1
Description
Intervention group: Tubeless percutaneous nephrolithotomy without any suture on the location of surgery
Category
Treatment - Surgery
2
Description
Control group: Tubeless percutaneous nephrolithotomy with one or two sutures on the location of surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Hospital
Full name of responsible person
Abdorasul Dadabaev
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dadabaevrasul46@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abdorasul Dadabaev
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
dadabaevrasul46@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Seyyed Habibollah Moosavi Bahar
Position
Urologist
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
shmbahar@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
Undecided - It is not yet known if there will be 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