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CTRI Number  CTRI/2023/11/060307 [Registered on: 29/11/2023] Trial Registered Prospectively
Last Modified On: 26/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   A study to assess the role of kidney stone culture in predicting and treating infections occurring after Percutaneous Nephrolithotripsy(PCNL) surgery for kidney stone. 
Scientific Title of Study   Correlation between stone culture and infective complications of PCNL 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Krishnakanth AVB 
Designation  Registrar 
Affiliation  Kasturba Medical College and Hospital 
Address  Room no:14, OPD block, Kasturba Medical College and Hospital, Madhavnagar, Manipal, Udupi-576104

Udupi
KARNATAKA
576104
India 
Phone  9655181450  
Fax    
Email  krishnakanth002@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Padmaraj Hegde 
Designation  Head of Unit 2 - Department of Urology and Renal Transplant 
Affiliation  Kasturba Medical College and Hospital 
Address  Room no:14, OPD block, Kasturba Medical College and Hospital, Madhavnagar, Manipal, Udupi-576104

Udupi
KARNATAKA
576104
India 
Phone  9900264579  
Fax    
Email  padmaraj.hegde@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Krishnakanth AVB 
Designation  Registrar 
Affiliation  Kasturba Medical College and Hospital 
Address  Room no:14, OPD block, Kasturba Medical College and Hospital, Madhavnagar, Manipal, Udupi-576104

Udupi
KARNATAKA
576104
India 
Phone  9655181450  
Fax    
Email  krishnakanth002@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College and Hospital 
 
Primary Sponsor  
Name  Kasturba Medical College and Hospital 
Address  Kasturba Medical College and Hospital, Madhavnagar, 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 Krishnakanth AVB  Kasturba Medical College and Hospital  Room no: 14, Department of Urology and Renal Transplant OPD, First floor, OPD block, Kasturba Medical College and Hospital, Madhavnagar, Manipal, Udupi-576104
Udupi
KARNATAKA 
9655181450

krishnakanth002@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  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  0.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients undergoing PCNL.
Patients treated for prior stone related uro-sepsis.
Presence of indwelling DJ stent/ catheter or PCN (Subset – To assess their microbial characteristics). 
 
ExclusionCriteria 
Details  As it is only an observational study, no exclusion criteria is being applied. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Correlation between stone culture and infective complications of PCNL.  Baseline, POD-0,POD-1 and at 4 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation between stone culture & renal function.
Correlation between stone culture & pre-operative urine culture in all patients included in the study.
Correlation between stone culture & blood culture in patients with uro-sepsis before or after PCNL.
Culture & sensitivity patterns in our population.
Correlation between stone culture & stone analysis.
Correlation between stone culture & staghorn calculi. 
Baseline, POD-0,POD-1 & at 4 weeks. 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
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   N/A 
Date of First Enrollment (India)   05/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  05/12/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Urosepsis in post-operative period may prove to be catastrophic despite adequate pre-operative antibiotic coverage, and negative urine culture. Culture of the stone could thus be used as an early guide for treatment or prevention of post-operative urosepsis. Stone culture is not a usual practice in endourologic surgeries, and pre-operative urine cultures have been heavily relied on for treatment of post-operative infections and sepsis. The aim of this study was to find correlation between intra-operative stone culture obtained during PCNL with pre-operative urine culture and its correlation with infective complications related to the procedure.

Primary Objective -   To assess the correlation between stone culture and infective complications of PCNL.

Justification for study : The high rates of post-PCNL infective complications warrant the need for well-defined predictive factors and high index of suspicion in the prediction of such complications. Stone culture will help in predicting infective complications in PCNL and help in administering appropriate intervention.

Benefits of the study:

In determining the role of stone culture in predicting infective complications of PCNL so as to administer timely intervention.

To assess the stone culture sensitivity in local population so that any changes if required can be implemented in the current antibiotic protocol in our department.

Ethical considerations:  Institutional Ethics Committee clearance obtained. Consent forms will be obtained from the patient if they are willing to participate in the study. Confidentiality will be maintained as identities of participants will not be revealed and only their hospital ID numbers will be used for reference in the study.          

Study Hypothesis - There is positive correlation between stone culture and occurrence of postoperative infective complications of PCNL. 


 
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