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CTRI Number  CTRI/2018/10/016076 [Registered on: 18/10/2018] Trial Registered Prospectively
Last Modified On: 17/10/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Observation of complications of Percutaneous Nephrolithotomy (PCNL) procedure using Modified Clavien Grading System  
Scientific Title of Study   A prospective observational study of complications of Percutaneous Nephrolithotomy (PCNL)using Modified Clavien Grading System 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Akshay Kriplani 
Designation  Urology Registrar  
Affiliation  Kasturba Medical College 
Address  Room no 14 Department of Urology Kasturba Hospital Manipal

Udupi
KARNATAKA
576104
India 
Phone  8668955602  
Fax    
Email  akshaykriplani@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Arun Chawla 
Designation  Professor urology 
Affiliation  Kasturba Medical College 
Address  Room no. 14 Department Of Urology Kasturba Hospital

Udupi
KARNATAKA
576104
India 
Phone  9008002440  
Fax    
Email  urologyarun@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Akshay Kriplani 
Designation  Urology Registrar  
Affiliation  Kasturba Medical College 
Address  Room no. 14 Department Of Urology Kasturba Hospital

Udupi
KARNATAKA
576104
India 
Phone  8668955602  
Fax    
Email  akshaykriplani@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College Manipal 576104 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  Kasturba Medical College Manipal 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 
Akshay Kriplani  Kasturba Medical College  Room no. 14, Department of Urology, Kasturba Hospital, Manipal 576104
Udupi
KARNATAKA 		 8668955602

akshaykriplani@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Kasturba Medical College and Kasturba Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  95.00 Year(s)
Gender  Both 
Details  All patients between the age group of 5 to 95 years who are scheduled to undergo PCNL shall be included in the observational study. 
 
ExclusionCriteria 
Details  Among the patients being posted for PCNL, no patients shall be excluded 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the post-operative complications of PCNL by using the modified Clavien Grading System in patients of renal calculi/ Upper ureteric calculi.  Immediate postoperative period and one month after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the variation in complication rates according to the varying patient factors, stone factors and the operative procedure.  Immediate Postoperative period and one month after surgery. 
 
Target Sample Size   Total Sample Size="500"
Sample Size from India="500" 
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)   28/10/2018 
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="1"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Title of the project: A prospective observational study of complications of Percutaneous Nephrolithotomy (PCNL) using Modified Clavien Grading System

 

Type of Study: Prospective, single center, observational study.

 

Objectives:

Primary:  To evaluate the postoperative complications of PCNL by using the Modified Clavien Grading System in patients of renal calculi/ upper ureteric calculi.

Secondary: To assess the variation in complication rate according to the varying patient factors, stone factors and the operative procedure.

 

Inclusion Criteria: All patients with renal calculi or upper ureteric calculus who were planned to undergo PCNL.

Exclusion criteria: None.

 

Detailed description of procedure / processes:

All patients from the study population will undergo standard preoperative evaluation.

Data collected will include patient demographics (Name, Age, Sex, BMI), their associated comorbidities and any history of previous surgeries of the same kidney.

Laboratory investigations (Complete blood count, renal function tests, urine routine and culture) and Imaging findings (USG KUB/ X-ray KUB/ CT KUB/ IVP) of these patients shall be documented.

All patients will undergo CT (Plain or Contrast enhanced) KUB. Stone characteristics in relation to location, size, number, laterality, HU, associated Hydroureteronephrosis and stone burden as studied on CT shall be noted. Bone density, Aortic Calcification and Visceral fat shall also be documented from the CT scans.

Various stone scoring systems (S.T.O.N.E, GUY, CROES, S-ReSC) shall be applied.

Anatomic Variations on imaging like malrotated kidney, Horseshoe kidney, supernumerary kidney, duplex pelvicalyceal system or any spinal anomalies shall be looked for.

Procedure specific variables like Supine PCNL or Prone PCNL, type of PCNL (Standard / MiniPCNL / Micro PCNL), number of punctures, Site of puncture (Superior/ Middle/ Inferior Calyx), Supracostal/ infracostal puncture, Primary and secondary tract size (Amplatz), Mode of stone fragmentation (Lithoclast, Laser, Mixed, Lithovac), Clearance of stone on endoscopy and fluoroscopy (total/ partial) shall be recorded.

Intraoperative parameters noted includes: amount of saline used, fluoroscopy time, stone fragmentation time, nephroscopy time, total procedure time, use of DJ stent/ Ureteric catheter, nephrostomy placement (suction catheter/ Malecots/ PCN tube), use of Flexible nephroscopy (if done), Ureteroscopy- Ipsilateral/contralateral/Bilateral (if done in the same sitting), or a Simultaneous Contralateral PCNL (if done)

Stone specimen shall be sent for analysis.

Postoperative parameters like pain (assessed by Visual Analog Scale), Fever (37C/ 98.6F), or respiratory distress shall be looked for. At 6 hours postoperatively fall in Hemoglobin, rise in Total Leucocyte Count and Creatinine rise shall be measured. Need for blood transfusion, length of hospital stay, symptoms/signs suggestive of adjacent organ injury or an increasing perirenal hematoma on USG shall be noted.

Patients will be followed up after one month with USG KUB/ X-ray KUB.

 

Outcome measures:

Complications observed postoperatively and in follow up shall be documented and shall be correlated with respective patient factors, stone factors and procedure specific factors

 
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