Comparison of two surgeries - Standard and Tubeless Percutaneous Nephrolithotomy for the treatment of kidney stones - A Prospective randomized control study

Not yet recruiting

• Conditions: Calculus of kidney, Renal Calculus Disease,

• Registration Number: CTRI/2018/07/015022

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
5. hospital stay (in hours)	7 days
3. pain score (visual analog scale)	7 days
4. analgesic requirement [13](morphine equivalents)	7 days
1. hemoglobin drop (in gm/dl)	7 days
2. operative time ( in min)	7 days

Secondary Outcome Measures

Name	Time	Method
1. post op bleeding [12]	2. post op pyrexia (temperature chart)

Trial Locations

Locations (1)

Government Medical College, Trivandrum; 🇮🇳 Thiruvananthapuram, KERALA, India

Government Medical College, Trivandrum

🇮🇳Thiruvananthapuram, KERALA, India

Manu M K

Principal investigator

9495746829

drmanumk@gmail.com