Stesura Seveso Archivio Italiano di Urologia e Andrologia 2020; 92, 2149 ORIGINAL PAPER Comparison of the efficiency, safety and pain scores of holmium laser devices working with 20 watt and 30 watt using in retrograde intrarenal surgery: One center prospective study Sercan Sari 1, Mehmet Çağlar Çakici 2, İbrahim Güven Kartal 2, Volkan Selmï 1, Harun Özdemïr 3, Hakkı Ugur Ozok 4, Ahmet Nihat Karakoyunlu 2, Serkan Yildiz 5, Emre Hepşen 6, Serra Ozbal 7, Hamit Ersoy 2 1 Bozok University, Department of Urology,Yozgat, Turkey; 2 University of Health Sciences, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Urology, Ankara, Turkey; 3 University of Health Sciences, Haseki Training and Research Hospital, Istanbul, Turkey; 4 Karabuk Unıversity, Department of Urology, Karabuk, Turkey; 5 Siirt State Hospital, Department of Urology, Siirt, Turkey; 6 Çubuk State Hospital,Department of Urology, Ankara,Turkey; 7 University of Health Sciences, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Radiology, Ankara, Turkey. Objectives: Holmium:Yttrium Aluminum Garnet laser lithotripsy is used in Retrograde Intrarenal Surgery. Fragmentation is made with a certain value of pulse energy (Joule) and frequency (Hertz) in Holmium laser lithotripsy and the multiplication of these values gives us total power (Watt). Devices with maximum power of 20 Watt and 30 Watt are used in clinical practice. We want to compare the effi- ciency, safety and pain scores of the lithotripsy made below 20 Watt and over 30 Watt with 30 Watt laser device. Materials and methods: 60 patients who had 2-3 cm sized kidney stones and operation planned were prospectively divided into three groups. Groups were random identified. In the first group, fragmentation was performed below 20 Watt power with 20 Watt laser device. In the second group, fragmentation was per- formed below 20 Watt power with 30 Watt laser device. In the third group, fragmentation was performed over 20 Watt power with 30 Watt laser device. Demographic, stone, intraoperative and postoperative data were recorded. We compared these groups regarding efficiency, safety and pain score. Results: For demographic and stone data, there was a statistical- ly significant difference only for stone number. For intraopera- tive and postoperative data, there was a statistically significant difference only for ureteral access sheath usage between the groups. Success was lower than the other groups in Group 1. Conclusions: Success was higher in groups using 30 Watt laser device. There was not statistically significantly difference between complications and pain. 30 Watt laser device is safe and efficient in Retrograde Intrarenal Surgery. KEY WORDS: Comparison; Efficiency; Kidney stone; Pain; Safety; Watt. Submitted 16 December 2019; Accepted 23 Decembe 2019 Summary No conflict of interest declared. DOI: 10.4081/aiua.2020.2.149 INTRODUCTION The increasing incidence of kidney stone disease caused the increasing number of lithotripsy in urology clinics (1). Retrograde intrarenal surgery (RIRS) is a new method. Its usage recently widened with advances of technology (2). Holmium:Yttrium Aluminum Garnet (Ho:YAG) laser lithotripsy is a lithotripsy method used in RIRS. Ho:YAG laser lithotripsy fragments stone with the photothermal mechanism (3). In Ho:YAG laser lithotripsy fragmentation is made with a certain value of pulse energy (Joule/J) and frequency (Hertz/Hz.). The multiplication of these values gives us total power (Watt/W). In clinical practice, the device with the maxi- mum power of 20 W was at first available. Recently the device with maximum power of 30 W has been used. In our study, we used these two devices. We want to com- pare efficiency, safety and pain scores of the lithotripsy made below 20 W and over 30 W with 30 W laser device. MATERIALS AND METHODS After receiving local ethical board approval, a randomized prospective study was planned. Study was recorded into National Clinical Trials (NCT) and NCT code was taken (NCT 02443909). Sixty patients who had 2-3 cm sized kidney stones and for whom RIRS was planned were divided into three groups. Groups were random identified. Informed consent was obtained from all individual partic- ipants included in the study. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethi- cal standards. Blood count, biochemical tests, coagulation tests, urine analysis, urine culture, kidney ureter bladder X- graphy (KUBG), urinary system ultrasonography (US), computerized tomography (CT) were preoperatively per- formed. Patients age, gender, body mass index (BMI), his- tory of shock wave lithotripsy (SWL), American Society of Anesthesiologists (ASA) score, previous stone surgery histo- ry, preoperative double J stent (JJ) history, anticoagulant usage, kidney anomaly, stone laterality, stone number, stone size and stone localization were recorded. 150Archivio Italiano di Urologia e Andrologia 2020; 92, 2 Comparison of 20 Watt 30 Watt laser devices Preoperative urine culture was sterile Patients were taken Dexketoprofen Trometamol twice a day as the analgesic and anti-inflammatory treatment after the operation. Visual analogue scale (VAS) was filled at postoperative eighth hours by patients. Patients marked the value equal to his/her pain in the VAS. The marked value was recorded. Intraoperative operation time, scopy time, postoperative JJ stent rate, ureteral access sheath (UAS) usage, hospitalization time and com- plications were recorded. Complications were evaluated according to modified Clavien and Dindo classification. The patients who had kidney anomalies, were < 18 years old, had urinary system infections in the preoperative evaluations were excluded from the study. The patients were divided into three groups. In the first group, frag- mentation was performed below 20 W power with 20 W laser device. In the second group, fragmentation was performed below 20 W power with 30 W laser device. In the third group, fragmentation was performed over 20 W power with 30 W laser device. We used dusting and fragmentation methods in our study. Preoperative antibiotic was administered to all patients. RIRS was performed under general anesthesia with 7.5 French (Fr) flexible renoscope (Flex-X2; Karl Storz, Tutlingen, Germany). After general anesthesia in modified supine position, the patient was taken to modified dor- sal lithotomy position. Semi-rigid ureterorenoscope was applied into the ureter under fluoroscopic control and 0.035/0.038 inch hydrophilic safety wire was placed into the ureter under fluoroscopic control. Semi-rigid ureterorenoscopy was performed. In case of semirigid ureterorenoscopy failure due to ureteral stricture, JJ stent was placed and the operation ended. After semirigid ureterorenoscopy, 9.5-11.5 Fr or 11-13 Fr access sheath (Elit Flex, Ankara, Turkey) was placed into the ureter up to the ureteropelvic junction under fluoroscopic control. Then flexible renoscope was placed through the UAS to provide access to the kidney. When access sheath was not placed, flexible renoscope was moved via safety wire to access the kidney. Fragmentation was performed via 200 mm: Yttrium Aluminum Garnet laser probe (Dornier Medilas H20 and HSolvo; Medtech, Munich, Germany) after the stone had been reached. In Group 1 and 2, 8-10 Hz. frequency and 1.2-1.8 J pulse ener- gy were used. In Group 3, 10-12 Hz. frequency and 2-3 J pulse energy were used. We used dusting and fragmenta- tion methods. All calices were explored with flexible renoscope at the end of operation under fluoroscopic control. JJ stent was placed into the ureter due to intraoperative conditions. JJ stent was taken three weeks later with an outpatient procedure. KUBG and US were performed on post- operative first day. CT was performed at postoperative third month. Patients who were stone free or had clinically insignificant residual fragment (< 2 mm) after intraoperative and postoper- ative controls, were evaluated as successful. We com- pared groups regarding efficiency, safety and pain score. Statistical analysis Analysis was made with SPSS for Windows 16.0 package program. Normality of numerical measurement values distributions was at first researched. One-Sample Kolmogorov-Smirnov test was used to determine the dis- tributions of parameters except for age, BMI and opera- tion time. The distributions were not normal (p < 0.05). Kruskal Wallis test was used to determine whether there was difference between two groups for gender, ASA score, stone laterality, stone localization, stone number, stone size, UAS usage, postoperative JJ stent usage, resid- ual stone, scopy time, previous stone surgery history, SWL history, intraoperative and postoperative complica- tions, anticoagulant usage and VAS score. In the patients with statistically significant differences in Kruskal Wallis test, to determine from which group the difference orig- inated in the analyze, Mann-Whitney U test was used to perform dual comparisons. One-Way Anova test was performed to determine whether there was a statistical difference between the groups for age, BMI and opera- tion time. P < 0.05 value was accepted as statistically sig- nificant for results. RESULTS When we look at demographic and stone data, there was no statistically significant difference for the parameters age, gender, BMI, ASA, SWL history, previous stone sur- gery history, anticoagulant usage, preoperative JJ stent, stone laterality, stone size and stone localization between the groups. There was a statistically significant difference for stone number (p = 0.036) (Table 1). When we evaluate intraoperative and postoperative data, there was no statistically significant difference for opera- tion time, scopy time, postoperative JJ stent usage and hospitalization time. There was a statistically significant Table 1. Demographic and stone characteristics. Group 1 (n = 20) Group 2 (n = 20) Group 3 (n = 20) p Age (years) ( ± SD) 51.15 ± 12.58 47.75 ± 14.26 54.45 ± 14.45 0.315 Gender (M/F) (n) 8/12 14/6 12/8 0.154 BMI (kg/m2) ( ± SD) 28.57 ± 4.43 28.12 ± 4.60 26.42 ± 3.97 0.265 ASA mean (n) 1.551 1.3525 1.671 0.409 SWL history (n, %) 5 (25) 2 (10) 3 (15) 0.438 Previous surgery history (n, %) 9 (45) 5 (25) 5 (25) 0.298 Anticoagulant usage (n, %) 1 (5) 0 0 0.368 Preoperative JJ stent (n, %) 8 (40) 2 (10) 5 (25) 0.094 Stone laterality (R/L) (n) 9/11 7/13 7/13 0.758 Stone number (n) ( ± SD) 1.85 ± 0.48 2.20 ± 0.89 1.75 ± 1.41 0.036 Stone size (mm) (± SD) 22.30 ± 3.21 22.60 ± 3.33 23.90 ± 4.09 0.56 Stone localization (n, %) 0.55 Upper calyx (n, %) 1 (5) 1 (5) 1 (5) Lower calyx (n, %) 6 (30) 6 (30) 5 (25) Mid calyx (n, %) 0 0 2 (10) Pelvis (n, %) 2 (10) 3 (15) 8 (40) Multicaliceal (n, %) 11 (55) 10 (50) 4 (20) M/F: Male/female; BMI: Body Mass Index; ASA: American Society of Anesthesiologists; JJ: Double J; SWL: Shock Wave Lithotripsy. Archivio Italiano di Urologia e Andrologia 2020; 92, 2 S. Sari, M. Çağlar Çakici, İ. Güven Kartal, V. Selmï, H. Özdemïr, H. Ugur Ozok, A. Nihat Karakoyunlu, S. Yildiz, E. Hepşen, S. Ozbal, H. Ersoy 151 difference for UAS usage between the groups. There was no statistically insignificant difference between the groups for VAS score (Table 2). When we look at success, in Group 1 seven patients, in Group 2 sixteen patients, and in Group 3 fifteen patients were stone free. The difference was statistically significant (p = 0.006). In Group 1 the operation was unsuccessful in one patient due to malfunctioning of the device, in four patients due to ureteral stricture and in eight patients due to inability to reach the stone. In Group 2, the operation was unsuccessful in one patient due to the malfunctioning of the device, in three patients due to inability to reach the stone. In Group 3, the operation was unsuccessful due to ureteral stricture in one patient, in two patients due to inability to reach the stone and in two patients due to stone burden. There was not clinically insignificant resid- ual fragment in any group (Table 2). Complications were seen in five patients for Group 1, eight patients for Group 2 and four patients for Group 3 (p = 0.35). Intraoperative complications were seen in three patients for Group 1, five patients for Group 2 and one patient for Group 3 (p = 0.214). Postoperative com- plications were seen in two patients for Group 1, six patients for Group 2 and three patients for Group 3. Bleeding was the intraoperative and postoperative asso- ciated complication in Group 2 (Table 2). DISCUSSION RIRS is a method of increasing use in kidney stone treat- ment (4). Ho:YAG laser is used in RIRS. A certain value of frequency (Hz.) and pulse energy (J) are used in Ho:YAG laser lithotripsy. The multiplication of these values give us power (W). There are studies to determine optimum power settings in Ho:YAG laser lithotripsy in the literature (5-7). These are in vitro studies. Human stones or stone-like material were used in these studies. In the same power set- tings, low frequency/high pulse energy and high frequency/low pulse energy were compared in these studies. In the same power settings, the low-frequency high pulse energy is more effective. There are studies that report pulse ener- gy is the major variable affecting frag- mentation efficiency (6). Total fragmen- tation increases as pulse energy increase (6). The increase of pulse energy pro- vides fast fragmentation but produces larger fragments (6). Retropulsion increases due to the increase of pulse energy (7-10). As retropulsion increases, the distance between fiber tip and stone decreases (7) and the energy applied to the stone decreases (11), so retropulsion decreases fragmentation efficiency (9). Also, the high pulse energy is associated with fiber tip malfunctioning and this causes low efficiency (6, 12). When we look at literature, fragmenta- tion speed increases as total power increases. There are studies about low power settings (13). In a study, shorter lithotripsy time was reported by high power settings (2.8 J and 15 Hz.), but there was not a comparison (14). In our study, we aimed to compare the efficiency, safety and pain score of the lithotripsy under 20 W and over 20 W power with two different laser devices in the same sized stones. When we look at demographic and stone characteristics, there was no statistically significant difference between the groups except the stone number. When we look at the operation data, there was statistically significant dif- ference between the groups for UAS usage rate and suc- cess. In group 1, UAS usage rate was lower than the other groups, that may explaun the higher number of ureteral stricture observed in Group 1. When success was evaluated, it was lower than the other groups in Group 1. The inability to reach the stone was seen in 8 patients for group 1, three patients for group 2 and two patients for group 3. The lower caliceal stone rates were similar between the groups. Multicaliceal stones rate was higher in group 1 and 2 than group 3. Failure due to ureter stricture was higher in group 1 than the other groups. This result can explain the lower success rate in group 1. Success was higher in the group in which 30 W laser device was used. The success rate was similar with literature except for group 1. In group 1, due to ureter stricture and multicaliceal stones, success was lower. In our study, first operation success was evaluated. Success reached 90-95% after repeating operations in all groups. There was no statistically significant difference between the groups for complications. The increasing pulse energy produces larger fragments (6), so larger residual fragments were seen in group 3. Also, steinstrasse was seen in one patient of group 3. Operation time was lower in group 3 than group 2 due to increasing pulse energy. Operation Table 1. !ntraoperative and Postoperative Data. Group 1 (n = 20) Group 2 (n = 20) Group 3 (n = 20) p Average Operation Time (min.) ( ± SD) 52.40 ± 21.29 61.45 ± 21.60 52 ± 18.23 0.263 Average Scopy Time (Sc.) (± SD) 57.05 ± 74.40 35.85 ± 24.13 32.50 ± 21.13 0.57 Postoperative JJ stent, n (%) 19 (95) 20 (100) 19 (95) 0.368 Uretheral Access Sheath Usage, n (%) 14 (70) 20 (100) 19 (95) 0.007 Average Hospitalisation Time (± SD) (day) 1 1 1 1 Success, (n) (%) 7 (35) 16 (80) 15 (75) 0.006 Stone-free 7 (35) 16 (80) 15 (75) Residual fragment (< 3 mm) 0 0 0 Residual fragment (≥ 3 mm) 13 (65) 4 (20) 5 (25) VAS Score (point) (± SD) 3.30 ± 2.15 2.20 ± 1.61 2.60 ± 1.23 0.409 Complication rate, n (%) 5 (25) 8 (40) 4 (20) 0.35 Intraoperative complication 3 (15) 5 (25) 1 (5) 0.214 Mucosal Injury, n (%) 1 (5) 1(5) 0 Bleeding, n (%) 1 (5) 3 (15) 0 Malfunctioning or breakage of instruments, n(%) 1 (5) 1(5) 0 Perforation, n (%) 0 0 1 (5) Postoperative complication 2 (10) 6 (30) 3 (15) Fever (Clavien I), n (%) 1 (5) 2 (10) 2 (10) Bleeding (Clavien I), n (%) 0 3 (15) 0 Urinary Tract Infection (Clavien II), n (%) 1 (5) 1(5) 0 Steinstrasse (Clavien IIIb), n (%) 0 0 1 (5) Min: Minutes; Sec: Seconds; JJ: Double J ; VAS: Visuel Analog Scale. 152Archivio Italiano di Urologia e Andrologia 2020; 92, 2 Comparison of 20 Watt 30 Watt laser devices time was similar between group 1 and 3. Due to the high number of unsuccessful patients in group 1, operation time was lower in group 1. The complication rate is high- er in our study when we compared it with literature data. The fewer patient number may explain this result, there- fore studies with larger patient number are needed. There was not a statistically significant difference between the groups for VAS score. There are few studies evaluating pain in the literature. Shoshtari et al. reported the main cause of admission to the hospital was pain (15). Singh et al. reported that patients undergoing RIRS had more pain than patients undergoing SWL at postoperative first and second day (16). Oguz et al. reported that female gender, stone size and UAS duration time in ureter were statisti- cally significant factors affecting pain (17). In a review researching the effect of female gender on pain scores, Tighe et al. observed that postoperative pain scores at first day were higher in females (18). Although there are stud- ies that report postoperative JJ stent decreases postopera- tive pain significantly, other studies report that JJ stent increases postoperative pain (19). In our study, postoper- ative JJ stent rate was similar between the groups. A limitation of our study was the absence of stone analy- sis. In a study, comparing Ho:YAG laser settings, differ- ent types stones or stone-like materials were used in vitro (5-7). Another limiting factor was the type of laser fiber used. A study reported that fragmentation changed due to use of different laser fiber types (6). The same laser fiber was used in three groups. Patient number is anoth- er limiting factor because larger patient number studies are needed. CONCLUSIONS For Ho:YAG laser lithotripsy in RIRS, success was higher in groups using 30 W laser device. There was not statisti- cally significantly difference between complication and pain rates. 30 W laser device is safe and efficient in RIRS. REFERENCES 1. 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Correspondence Sercan Sari, MD - sercansari92@hotmail.com Volkan Selmi, MD - volkanselmi@hotmail.com Bozok University, Department of Urology, Yozgat (Turkey) Mehmet Caglar Cakici, MD - mcaglarcakici@hotmail.com !brahim Güven Kartal, MD - igk84@hotmail.com Ahmet Nihat Karakoyunlu, MD - nkarakoyunlu@gmail.com Hamit Ersoy, MD - hamitersoy@gmail.com University of Health Sciences, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Urology, Ankara (Turkey) Harun Özdemir, MD - dr.harun-17@hotmail.com University of Health Sciences, Haseki Training and Research Hospital, Istanbul (Turkey) Hakkı Ugur Ozok, MD - drozok@gmail.com Karabuk Unıversity, Department of Urology, Karabuk (Turkey) Serkan Yildiz, MD - s_yildiz55@yahoo.com Siirt State Hospital, Department of Urology, Siirt (Turkey) Emre Hepsen, MD - emreepsen@hotmail.com Çubuk State Hospital,Department of Urology, Ankara (Turkey) Serra Ozbal, MD - sozbal@gmail.com University of Health Sciences, Dışkapı Yıldırım Beyazıt Training and Research Hospital, Department of Radiology, Ankara (Turkey)