Wen Zhong1, Junjun Wen1, Linjie Peng1, Guohua Zeng2. 1. Department of Urology, Minimally Invasive Surgery Center, Guangdong Key Laboratory of Urology, Guangzhou Institute of Urology, The First Affiliated Hospital of Guangzhou Medical University, 1 Kangda Road, Haizhu District, Guangzhou, 510230, Guangdong, China. 2. Department of Urology, Minimally Invasive Surgery Center, Guangdong Key Laboratory of Urology, Guangzhou Institute of Urology, The First Affiliated Hospital of Guangzhou Medical University, 1 Kangda Road, Haizhu District, Guangzhou, 510230, Guangdong, China. gzgyzgh@vip.sina.com.
Abstract
OBJECTIVE: In the present prospective randomized controlled trial (RCT), enhanced-SMP (eSMP) and conventional Chinese mini-PCNL (mPCNL) were compared to test the low renal pelvic pressure (RPP) and high stone removal efficiency in eSMP. MATERIALS AND METHODS:Hundred patients with 2-5 cm renal calculus were enrolled. Renal pelvic pressure, operation time, lithotripsy time, removed stone volume, and complications were compared between eSMP and mPCNL statistically. RESULTS: There was no significant difference in removed stone volume between mPCNL and eSMP (8.09 ± 3.36 vs. 7.88 ± 3.07 mm3, t = 0.320, p = 0.750), lithotripsy time in mPCNL was longer than eSMP (49.6 ± 19.5 vs. 34.9 ± 14.2 min, t = 4.152, p < 0.001), thus stone removal efficiency was higher in eSMP (13.71 ± 1.18 vs. 9.82 ± 1.24 mm3/h, t = 15.499, p < 0.001). Intra-operative RPP in mPCNL was higher than eSMP (17.72 ± 3.33 vs. 12.03 ± 2.37 mmHg, t = 9.524, p < 0.001); accumulated time of backflow status (RPP > 30 mmHg) in mPCNL was longer than eSMP (23.3 ± 16.9 vs. 3.7 ± 4.2 s, t = 7.710, p < 0.001). There was no significant difference in postoperative fever rate between mPCNL and eSMP (12.77% vs. 4.34%, χ2 = 2.095, p = 0.148), nor final stone-free rate (87.2% vs. 91.3%, χ2 = 0.401, p = 0.526). Hospital stay in eSMP was shorter than mPCNL (2.54 ± 0.72 vs. 3.00 ± 0.88, t = 2.724, p = 0.008). CONCLUSION: Enhanced SMP (eSMP) was safe and effective in the management of 2-5 cm renal calculus. It can keep a lower renal pelvic pressure and a higher stone removal efficiency when compared to conventional Chinese mini-PCNL. CLINICAL TRIAL REGISTRATION: NC03206515.
RCT Entities:
OBJECTIVE: In the present prospective randomized controlled trial (RCT), enhanced-SMP (eSMP) and conventional Chinese mini-PCNL (mPCNL) were compared to test the low renal pelvic pressure (RPP) and high stone removal efficiency in eSMP. MATERIALS AND METHODS: Hundred patients with 2-5 cm renal calculus were enrolled. Renal pelvic pressure, operation time, lithotripsy time, removed stone volume, and complications were compared between eSMP and mPCNL statistically. RESULTS: There was no significant difference in removed stone volume between mPCNL and eSMP (8.09 ± 3.36 vs. 7.88 ± 3.07 mm3, t = 0.320, p = 0.750), lithotripsy time in mPCNL was longer than eSMP (49.6 ± 19.5 vs. 34.9 ± 14.2 min, t = 4.152, p < 0.001), thus stone removal efficiency was higher in eSMP (13.71 ± 1.18 vs. 9.82 ± 1.24 mm3/h, t = 15.499, p < 0.001). Intra-operative RPP in mPCNL was higher than eSMP (17.72 ± 3.33 vs. 12.03 ± 2.37 mmHg, t = 9.524, p < 0.001); accumulated time of backflow status (RPP > 30 mmHg) in mPCNL was longer than eSMP (23.3 ± 16.9 vs. 3.7 ± 4.2 s, t = 7.710, p < 0.001). There was no significant difference in postoperative fever rate between mPCNL and eSMP (12.77% vs. 4.34%, χ2 = 2.095, p = 0.148), nor final stone-free rate (87.2% vs. 91.3%, χ2 = 0.401, p = 0.526). Hospital stay in eSMP was shorter than mPCNL (2.54 ± 0.72 vs. 3.00 ± 0.88, t = 2.724, p = 0.008). CONCLUSION: Enhanced SMP (eSMP) was safe and effective in the management of 2-5 cm renal calculus. It can keep a lower renal pelvic pressure and a higher stone removal efficiency when compared to conventional Chinese mini-PCNL. CLINICAL TRIAL REGISTRATION: NC03206515.