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A novel spherical-headed fascial dilator is feasible for second-stage ultrasound guided percutaneous nephrolithotomy: A pilot study |
Yiwei Wanga,1,Liheng Gaob,1,Mingxi Xua,1,Wenfeng Lia,Yuanshen Maoa,Fujun Wangb,Lu Wangb,Jun Daa,*( ),Zhong Wanga,*( )
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a Department of Urology, Ninth People’s Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China b Key Laboratory of Textile Science and Technology, Ministry of Education, College of Textiles, Donghua University, Shanghai, China |
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Abstract Objective: In second-stage percutaneous nephrolithotomy (PCNL), because the hydronephrosis has been decompressed, the dilated renal pelvis has resolved and the space is small. Consequently, introduction of the tip of the Amplatz dilator can cause injury to the opposite side of the renal-pelvic mucosa. In this study, we report the experimental and initial clinical performance of a spherical-headed fascial dilator developed specifically for second-stage PCNL. Methods: The novel spherical-headed dilator was compared with existing tapered-headed dilators in configuration and in puncture resistance utilizing a static puncture test. Subsequently, a pilot clinical study was conducted during which patients scheduled to undergo second-stage PCNL from June 2019 to October 2019 in our center were enrolled. A typical ultrasound guided PCNL procedure was performed with the exception that the new spherical-headed fascial dilator was substituted for a tapered-headed one. Results: Experimentally, stab resistance against polyethylene film was significantly increased using the novel spherical-headed dilator compared to the traditional tapered-headed dilators (p<0.005). In the clinical study, the novel dilators were successfully introduced into the renal pelvis and passed down the collecting system in all eight second-stage PCNL cases. There were no cases of renal pelvic perforation or brisk hemorrhage nor need for transfusion. Conclusion: The design of the novel spherical-headed fascial dilator avoided the concentration of pressure at the tapered tip of the current Amplatz dilator by increasing the contact area and uniformly distributing and diffusing the pressure. Therefore, it is feasible to use the spherical-headed fascial dilator for second-stage PCNL.
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Received: 28 February 2020
Available online: 15 April 2021
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Corresponding Authors:
Jun Da,Zhong Wang
E-mail: phillda@sh9hospital.org.cn;wangz1658@sh9hospital.org.cn
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Morphology of dilators. D1 and D2 dilaters have tapered heads with flat tips; D3 dilator has a sphericalhead. D means bulk diameter; d means tip diameter; C means taper; r means radius of curvature; L means cone length. The physical features of stated dilaters are listed in Table 1.
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Sample No. | Type | Bulk diameter, mm | Tip diameter, mm | Cone length, mm | Taper, mm | Radius of curvature, mm | D1 | Tapered | 5.00 | 0.79 | 22.15 | 0.226 | - | D2 | Tapered | 5.00 | 0.90 | 11.55 | 0.433 | - | D3 | Spherical | 5.00 | - | - | - | 3.90 |
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Morphological features of the dilators.
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Static puncture resistance-displacement behavior of dilators against PE or NBR film. (A and B) Typical puncture resistance-displacement curve; (C) Displacements of dilators; (D) Puncture resistance of dilators; (E) Puncture work of dilators; (F) Testing method. PE, polyethylene; NBR, nitrile butadiene rubber.
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Characteristc | Value | Age, mean (range), year | 50.1 (31-70) | Male/female, n | 6/2 | Right/left, n | 3/5 | Reason for a second stage PCNL, n | Residual stone | 2 | Large stone burden | 4 | Pyonephrosis | 2 | Stone size, mean (range), mm | 18.1 (10-30) | Time between the two procedures, mean (range), week | 3.1 (2-4) | Preoperativeblood hemoglobin concentration, mean (range), g/L | 134 (128-143) | Postoperative blood hemoglobin concentration, mean (range), g/L | 132 (122-142) | Operative time, mean (range), min | 50 (35-72) | Postoperative hospital stay, mean (range), day | 1.6 (1-3) | Clavien II-IV complication rate, % | 0 | Urinary leakage, n | 0 |
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Patient characteristics and perioperative findings.
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