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CTRI Number  CTRI/2018/07/015022 [Registered on: 24/07/2018] Trial Registered Prospectively
Last Modified On: 26/12/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of two surgeries - Standard and Tubeless Percutaneous Nephrolithotomy for the treatment of kidney stones - A Prospective randomized control study 
Scientific Title of Study   Comparison of Standard and Tubeless Percutaneous Nephrolithotomy for Renal calculi - A Prospective randomized control trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Manu M K 
Designation  Additional Professor 
Affiliation  Government Medical College, Thiruvananthapuram 
Address  Department of Urology Superspeciality Block Government Medical College Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9495746829  
Fax    
Email  drmanumk@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Manu M K 
Designation  Additional Professor 
Affiliation  Government Medical College, Thiruvananthapuram 
Address  Department of Urology Superspeciality Block Government Medical College Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9495746829  
Fax    
Email  drmanumk@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Manu M K 
Designation  Additional Professor 
Affiliation  Government Medical College, Thiruvananthapuram 
Address  Department of Urology Superspeciality Block Government Medical College Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  9495746829  
Fax    
Email  drmanumk@gmail.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  none 
Address 
Type of Sponsor  Government 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 
Manu M K  Government Medical College, Trivandrum  Department of Urology 1st Floor, Superspeciality Block Government Medical College Trivandrum 695011
Thiruvananthapuram
KERALA 
9495746829

drmanumk@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Committee, Thiruvananthapuram, Kerala  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney, Renal Calculus Disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group 1 Standard Percutaneous Nephrolithotomy (Standard PCNL)  Group 1 in which after the procedure (Standard PCNL), a 20 F nephrostomy tube will be inserted into the pelvicalyceal system along with ureteral stent 
Intervention  Group 2 Tubeless Percutaneous Nephrolithotomy (Tubeless PCNL)  Group 2 in which after the procedure only ureteral stent and no nephrostomy tube will be inserted (Tubeless PCNL) 
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Those who are diagnosed to have renal calculi and consenting for the study
2. Those with renal calculi of size < 3cm
3. Those with procedure completed with single puncture tract
4. Those with duration of procedure < 2 hours
5. Those with complete stone clearance at the end of the procedure confirmed by fluoroscopy and endoscopy
6. Those without significant bleeding during the procedure
7. Those with intact pelvicalyceal system at the end of the procedure
 
 
ExclusionCriteria 
Details  1. Those with staghorn renal calculus, renal anatomical abnormalities, coagulopathies and unfit for general anaesthesia
2. Those with active urinary tract infection
3. Those who are not fulfilling inclusion criteria
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. hemoglobin drop (in gm/dl)
2. operative time ( in min)
3. pain score (visual analog scale)
4. analgesic requirement [13](morphine equivalents)
5. hospital stay (in hours) 
7 days 
 
Secondary Outcome  
Outcome  TimePoints 
1. post op bleeding [12]
2. post op pyrexia (temperature chart)
3. urine leak (yes/no)
4. blood transfusion (yes/no) 
7 days 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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)   01/08/2018 
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)   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  
Percutaneous Nephrolithotmy (PCNL) is the standard method for removal of large stones. Since its first description in 1976 by Fernström and Johansson, [1] considerable changes have occurred in the techniques and technology of PCNL. PCNL was associated with morbidities such as bleeding, pyrexia, incomplete stone removal, pleural injury, and adjacent organ injury. [2] After completion of stone removal, traditionally, a nephrostomy tube is placed. This helped in tamponade of bleeding, drainage of urine, tract recovery, and a guide for second look nephroscopy if needed. [3,4] Studies showed that smaller nephrostomy tubes were as effective as larger ones.[5-7]
Refinements in the technique, optics of the instruments, and better lithotripsy technologies have led to a reduction in these morbidities. The presence and removal of nephrostomy is associated with morbidities such as infection, pain, urine leak, bleeding, and prolonged hospitalization. [8]Bellman et al. in 1997 first described “tubeless” PCNL which involved placement of a ureteric stent without nephrostomy.[9] However, the presence of double‑J stent in tubeless PCNL is often associated with stent related problems such as frequency, urgency, nocturia, pain, and hematuria.[10]. In this study we will be evaluating the perioperative outcomes of tubless PCNL and compare it with standard PCNL. The purpose of this study is to determine whether tubeless PCNL are safe and less morbid management techniques for renal stones compared to the standard PCNL with nephrostomy tube.
1. Fernström I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol 1976;10:257‑9.
2. de la Rosette J, Assimos D, Desai M, Gutierrez J, Lingeman J, Scarpa R, et al. The Clinical Research Office of the Endourological Society Percutaneous Nephrolithotomy Global Study: Indications, complications, and outcomes in 5803 patients. J Endourol 2011;25:11‑7.
3. Paul EM, Marcovich R, Lee BR, Smith AD. Choosing the ideal nephrostomy tube. BJU Int 2003;92:672‑7.
4. Srinivasan AK, Herati A, Okeke Z, Smith AD. Renal drainage after percutaneous nephrolithotomy. J Endourol 2009;23:1743‑9.
5. Maheshwari PN, Andankar MG, Bansal M. Nephrostomy tube after percutaneous nephrolithotomy: Large‑bore or pigtail catheter? J Endourol 2000;14:735‑7.
6. Pietrow PK, Auge BK, Lallas CD, Santa‑Cruz RW, Newman GE, Albala DM, et al. Pain after percutaneous nephrolithotomy: Impact of nephrostomy tube size. J Endourol 2003;17:411‑4.
7. Desai MR, Kukreja RA, Desai MM, Mhaskar SS, Wani KA, Patel SH, et al. A prospective randomized comparison of type of nephrostomy drainage following percutaneous nephrostolithotomy: Large bore versus small bore versus tubeless. J Urol 2004;172:565‑7.
8. Borges CF, Fregonesi A, Silva DC, Sasse AD. Systematic review and meta‑analysis of nephrostomy placement versus tubeless percutaneous nephrolithotomy. J Endourol 2010;24:1739‑46.

9. Bellman GC, Davidoff R, Candela J, Gerspach J, Kurtz S, Stout L. Tubeless percutaneous renal surgery. J Urol 1997;157:1578‑82.

10.  Saltzman B. Ureteral stents. Indications, variations, and complications. Urol Clin North Am 1988;15:481‑91.

11. Tefekli A, Altunrende F, Tepeler K, Tas A, Aydin S, Muslumanoglu AY. Tubeless percutaneous nephrolithotomy in selected patients: A prospective randomized comparison. Int Urol Nephrol 2007;39:57‑63.

12. Crook TJ, Lockyer CR, Keoghane SR, Walmsley BH. A randomized controlled trial of nephrostomy placement versus tubeless percutaneous nephrolithotomy. J Urol 2008;180:612‑4.

13. WHO Guidelines: World Health Organization. Cancer pain relief: With a guide to opioid availability. 2nd ed. Geneva: WHO; 1996.
 
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