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CTRI Number  CTRI/2018/12/016522 [Registered on: 03/12/2018] Trial Registered Prospectively
Last Modified On: 14/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of two operative procedures, which uses scope of different sizes ( normal and smaller size) inserted into kidney through a small hole on the skin, for the removal of kidney stones less than 2 cm in size. 
Scientific Title of Study   Randomised Controlled Trial comparing Standard and Mini percutaneous nephrolithotomy in the management of renal calculi less than 2 cm size. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Raja Sekhar Guddeti 
Designation  MCh Registrar, Urology 
Affiliation  Manipal Academy of Higher Education 
Address  Room no : 14, Department of Urology, Kasturba Hospital, Manipal, Udupi.

Udupi
KARNATAKA
576104
India 
Phone  9989637640  
Fax    
Email  sekhar112raja@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Padmaraj Hegde 
Designation  MBBS, MS MCh  
Affiliation  Manipal Academy of Higher Education 
Address  Room no : 14, Department of Urology, Kasturba Hospital, Manipal, Udupi.

Udupi
KARNATAKA
576104
India 
Phone  9900264579  
Fax    
Email  padmaraj.hegde@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Raja Sekhar Guddeti 
Designation  MCh Registrar, Urology 
Affiliation  Manipal Academy of Higher Education 
Address  Room no : 14, Department of Urology, Kasturba Hospital, Manipal, Udupi.

Udupi
KARNATAKA
576104
India 
Phone  9989637640  
Fax    
Email  sekhar112raja@gmail.com  
 
Source of Monetary or Material Support  
Department of Urology, Kasturba Hospital, Manipal 
 
Primary Sponsor  
Name  Department of Urology 
Address  Room no 14 Kasturba Hospital Manipal Udupi 576104  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Raja Sekhar Guddeti  Department of Urology  Room no 14 Department of Urology Urology division KMC Manipal
Udupi
KARNATAKA 		 9989637640

sekhar112raja@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
kasturba medical college and kasturba hospital institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mini percutaneous nephrolithotomy  access sheath 14 - 22 Fr 
Comparator Agent  Standard percutaneous nephrolithotomy  access sheath 24 - 30 Fr 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients with Renal calculus less than 2 cm (Calculus size - longest axis by CT KUB) 
 
ExclusionCriteria 
Details  Calculus greater than 2 cm
Age less than 18 years
Untreated UTI
Bleeding diathesis
Markedly abnormal calyceal anatomy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy (stone-free rate) of standard and mini percutaneous nephrolithotomy.  1 month 
 
Secondary Outcome  
Outcome  TimePoints 
To Study the Operative time, Length of hospital stay and Post-operative pain score and
Analgesic requirement. 		 1 week 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/12/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   1) Yamaguchi A, Skolarikos A, Buchholz NP, Chomon GB, Grasso M, Saba P, et al. Operating times and bleeding complications in percutaneous nephrolithotomy: a comparison of tract dilation methods in 5,537 patients in the Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study. Journal of Endourology. 2011;25:933–939. 2)De la Rosette J, Assimos D, Desai M, et al. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: indications, complications, and outcomes in 5803 patients. Journal of Endourology. 2011;25:11–7. 3) Kukreja R, Desai M, Patel S, Bapat S, Desai M. Factors affecting blood loss during percutaneous nephrolithotomy: prospective study. Journal of Endourology. 2004;18:715–722. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   This study is a randomized, contolled single centre trial comparing the safety and efficacy of standard and mini percutaneous nephrolithotomy in the management of renal calculi less than 2 cm size that will be conducted in the department of urology, Kasturba Hospital, Manipal. The primary outcome will be comparision of efficacy ( stone free rate ) of standard and mini percutaneous nephrolithotomy. The secondary outcomes will be comparision of the operative time, length of hospital stay and post-operative pain score and analgesic requirement. 
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