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临床试验/CTRI/2018/07/015022
CTRI/2018/07/015022尚未招募不适用

Comparison of Standard and Tubeless Percutaneous Nephrolithotomy for Renal calculi - A Prospective randomized control trial

未提供1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年1月8日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
25
试验地点
1
主要终点
5. hospital stay (in hours)

研究概览

简要总结

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.

  1. 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.

  2. 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.

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

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
13.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 1.Those who are diagnosed to have renal calculi and consenting for the study 2.Those with renal calculi of size < 3cm
  • 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.

排除标准

  • 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.

结局指标

主要结局

5. hospital stay (in hours)

时间窗: 7 days

3. pain score (visual analog scale)

时间窗: 7 days

4. analgesic requirement [13](morphine equivalents)

时间窗: 7 days

1. hemoglobin drop (in gm/dl)

时间窗: 7 days

2. operative time ( in min)

时间窗: 7 days

次要结局

  • 1. post op bleeding [12](2. post op pyrexia (temperature chart))

研究者

发起方
未提供

研究点 (1)

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