None listed
Conditions
Brief summary
Purpose: To establish if a retropulsion prevention device for ureteral stones equalizes surgical success and push-back rates of Ho:YAG laser and pneumatic lithotripters for upper ureteral stones. Materials and Methods: Patients with upper ureteral stones (n=267) were treated endoscopically at the Department of Urology between April 2014 and December 2015. Patients were randomly assigned to pneumatic and Ho:YAG laser lithotripters as group-1 and group-2, respectively. Among the 267 patients three and four patients were excluded due to changing stone localizations in group-1 and group-2, respectively. Pneumatic lithotripsy was performed in 130 patients and laser lithotripsy was performed in 130 patients. Two patients in group-2 were excluded due to inappropriate follow-up.Lithotripsy was performed with Stone-coneTM in both groups. Results: The surgical success rate on the first postoperative day was 81.5% (n=106) and 90.6% (n=116) for group-1 and group-2, respectively, and the difference between the groups was statistically significant (p<0.05). The relation between stone size and surgical success was statistically significant for both groups (p<0.01). Surgical success for the stones closer than 2cm to the UPJ was 23.1% for the pneumatic group versus 64% for the laser group (p<0.01). Lithotripsy time was significantly longer in group-2 (16.48+/-4.74 min.) than group-1 (12.24+/-3.95 min.) (p<0.01). Conclusions: Ho:YAG laser can fragment the stone in place in the low-power settings and this provides high success rates with the use of a push-back prevention device, especially for very high level upper ureteral stones. Many clinics may not have unlimited access to flexible ureteroscopy. Ho:YAG laser lithotripsy is more successful than pneumatic lithotripsy for upper ureteral stones, and a retropulsion prevention device does not equalize the surgical success of Ho:YAG laser and pneumatic lithotripters for upper ureteral stones.
Interventions
Patients were treated with pneumatic(comparator) and Ho:YAG laser(intervention) lithotripters in group-1 and group-2, respectively. Pneumatic lithotripsy was performed in 130 patients and laser lithotripsy was performed in 130 patients. Two patients in group-2 were excluded due to inappropriate follow-up.
Ureteroscopy and lithotripsy were performed under spinal anesthesia for all patients. The surgeries were performed by the same surgical team (consultant urologist). Semi-rigid 7.5 or 9.5 Fr ur
Patients were treated with pneumatic(comparator) and Ho:YAG laser(intervention) lithotripters in group-1 and group-2, respectively. Pneumatic lithotripsy was performed in 130 patients and laser lithotripsy was performed in 130 patients. Two patients in group-2 were excluded due to inappropriate follow-up. Ureteroscopy and lithotripsy were performed under spinal anesthesia for all patients. The surgeries were performed by the same surgical team (consultant urologist). Semi-rigid 7.5 or 9.5 Fr ureterorenoscopes (Richard Wolf, Knittlingen, Germany) were used for ureteroscopy under lithotomy position. Initially, a hydrophilic guidewire for safety was inserted into the ureter under fluoroscopy or direct vision. After that, a Stone-coneTM Nitinol Retrieval Coin (Boston Scientific, Marlborough, MA, USA) was placed for retropulsion prevention but not activated. Thereafter, the stone cone was opened under direct vision or fluoroscopy and lithotripsy was performed with Ho:YAG laser (Sphinx 30 Minimally Invasive Surgical Laser, LISA laser, Pleasanton, CA, USA) lithotripter for group-2. For group-2, 365 microm laser fibers were used and lithotripsy was performed with 1.0-2.0 Joule 5-10 Hz (5-20 Watt) settings. Treating surgeon decided the adjustments of energy setting on the basis of stone characteristics during the surgery. At the end of efficient fragmentation, extraction of the stone fragments was performed with stone forceps and the Stone-coneTM was closed and withdrawn. Approximate duration of surgery was 48 minutes. Flexible ureterorenoscopy was not performed in any of patients simultaneously. A double–J stent was inserted for two weeks in patients with residual stone fragments, bleeding and ureteral edema.
Sponsors
Ahi Evran University, Academical Researches Supporting Unit
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 82 Years
Healthy volunteers
No
Inclusion criteria
Patients between 18 and 82 with obstructive, radioopaque and primary unilateral upper ureteral stones were included in this study.
Exclusion criteria
Exclusion criterias were abnormal coagulation profile, previous SWL, bilateral ureteral stones, radiolucent stones, likelihood of spontaneous stone passage, and presence of a non-functioning kidney. Patients with narrow ureters that required stenting and with push-back of the stone before activation of the stone cone were excluded. Stone localization in the fluoroscopic stone immediately prior to the surgery was compared with preoperative stone localizations. Patients with changing stone localizations were excluded from the study.
Outcome results
None listed