FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065508 [Registered on: 10/04/2024] Trial Registered Prospectively
Last Modified On: 09/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Comparing efficacy of supine and prone PCNL in kidney stone patients 
Scientific Title of Study   A comparative study between Supine and Prone Percutaneous Nephrolithotomy 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Devendra Singh Mehra 
Designation  Senior Resident 
Affiliation  RIMS,Imphal 
Address  Urology Department,RIMS Hospital,Imphal,Manipur

Imphal West
MANIPUR
795001
India 
Phone  8433263215  
Fax    
Email  mehradevendra39@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Akoijam Kaku Singh 
Designation  Professor  
Affiliation  RIMS,Imphal 
Address  Urology Department,RIMS Hospital,Imphal,Manipur

Imphal West
MANIPUR
795001
India 
Phone  8974057025  
Fax    
Email  drkakurims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Khumukcham Somarendra 
Designation  Assistant Professor 
Affiliation  RIMS,Imphal 
Address  Urology Department,RIMS Hospital,Imphal,Manipur

Imphal West
MANIPUR
795001
India 
Phone  9612165705  
Fax    
Email  drsomensingh@gmail.com  
 
Source of Monetary or Material Support  
RIMS,Imphal 
 
Primary Sponsor  
Name  Dr Devendra Singh Mehra 
Address  Urology Department,RIMS Hospital,Imphal,Manipur 
Type of Sponsor  Other [Self] 
 
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 Devendra Singh Mehra  RIMS Hospital  Urology department,First floor Room Number-3Lamphelpat,Imphal.Manipur
Imphal West
MANIPUR 
8433263215

mehradevendra39@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
RESEARCH ETHICS BOARD RIMS  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 
Comparator Agent  prone percutaneous nephrolithotomy  Patients presenting with renal stone disease in Urology OPD in RIMS Hospital,Imphal from September,2022 to August,2024(2 years) 
Intervention  Supine Percutaneous nephrolithotomy  September, 2022 to August, 2024.(2 years) 
 
Inclusion Criteria  
Age From  12.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients presenting with lower calyceal and pelvic renal stone upto size 2cm. 
 
ExclusionCriteria 
Details  1.Patients not willing to give consent to participate in the study.
2.Paediatric age group (<12year )
3.Bilateral stone disease.
4.Previous history of PCNL or pyelolithotomy.
5.Uncontrolled cougulopathy.
6.Abnormal renal anatomy.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Operative time
2.Post op hemoglobin drop
3. Number of blood transfusions
4.Type of complications after procedure (if any)
 
zero day(intra-operative). 
 
Secondary Outcome  
Outcome  TimePoints 
1.Need for Relook PCNL
2.Duration of Hospital Stay
3.Stone Free Rate at 4 weeks
 
At 1 week and 4 weeks. 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   23/04/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

Urolithiasis is a global disease with a prevalence rate of about 12% in Indian population and     out of which 50% may end up with loss of renal functions. PCNL (Percutaneous nephrolithotomy) stands as a gold standard surgical treatment for renal calculus disease. It has gradually replaced conventional open surgery for the removal of any size renal stone, specially large and complex one.

Since its first description by Fernstrom and Johansson in 1976, PCNL has traditionally been done with the patient prone, combining a high success rate and acceptable low morbidity.

The prone position has certain advantages like wide field of working area, easiness to puncture the calyx, shorter track length, ease of tract dilation, ease to do multiple punctures etc.But is associated with many problems like circulatory and ventilatory compromise because of compression on the chest especially in the obese patient; cervical spine injuries, tracheal compression and ocular injury during turning the patient; more fluid because of antigravity drainage of fluid.

Concurrent RIRS (Retrograde intrarenal surgery) is difficult in prone position. So there was a hunt in search of a new position which can ameliorate the disadvantages of traditional prone position.First original supine position was described by Valdivia et al. In this position the direction of the tract is downward and thus preserves a low pressure in the renal pelvis, and thereby reduces the risk of fluid absorption and allows spontaneous clearance/washout of fragments by gravity directed flow of fluid.The main limitation of this position is that the flank is not fully exposed, which makes initial puncture more difficult.

In 2007 The Galdakao-modified supine Valdivia position was described by Ibarluzea et al. for supine PCNL.

The aim is to compare the surgical outcomes between prone and supine PCNL.

This study will be done in patients who will be undergoing PCNL in urology department at RIMSH, Imphal, Manipur.

Study variables will include  age, gender,BMI,post operative haemoglobin drop,need for blood transfusion,mean operative time, number of patients developing complications,mean hospital stay,need for relook PCNL and stone free rate.

Patient will be evaluated with history, physical examination, urine analysis, urine culture and sensitivity, complete blood count, renal function tests, X-ray KUB, USG KUB, and Plain and contrast enhanced computed tomography / IVP.It is a convenience  non-probability sampling method where sample is collected from a group of people easy to reach or contact.After that patient who will be undergoing PCNL will be divided into two groups (Group A& Group B) which will be dicided by the cornerned operating surgeon.. Group A will undergo prone PCNL and Group B will undergo supine PCNL after obtaining anesthetic fitness for the procedure.

P-value <0.05 will be taken as statistically significant.

 
Close