| 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
|
|
|
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
|
|
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. |