Clinical trial NCT03980444: Effectiveness Basket Wires for the Maintenance of Stone and Pneumatic Probe in the Treatment of Ureteral Stones
Official title: Determine the Effectiveness of Convective Uses of Basket Wires for the Maintenance of Stone and Pneumatic Probe in the Treatment of Ureteral Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ureter Stone
Keywords: Ureterolithiasis
Manganese Poisoning
Lithotripsy
Ureteroscopy
stone baske
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2019-06-10
Enrollment: 124
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients included in the study included the necessary tests U/A, K, Na, Cr, BUN, CBC, And U / C was checked and anesthesia counseling was done. The demographic and clinical data of the patients were recorded.

Then patients as random allocation were divided into two groups: A (control group) and group B (use of a pneumatic basket of wire). The dividing person and the patients themselves were not aware of which group they were in.

In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A, the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock.

In group B (using a basket of wires3F) the helical type was passed through the four wires of the working channel of the orthoscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the same as A group.
Primary purpose: TREATMENT

Brief summary: Patients included in the study included the necessary tests U / A, K, Na, Cr, BUN, CBC, And U / C was checked and anesthesia counseling was done. Patients were prepared for action. The demographic and clinical data of the patients, including age, sex, size, and location of the stones were recorded.

Then patients as random allocation were divided into two groups: A (control group, no basket of bases and group B (use of pneumatic synchronous buccal waist). The dividing person and the patients themselves were not aware of which group they were in. They were double-blind was.

In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A (control), the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock.

During the crushing process, the minimum flow of water, flattening and the single-shot impact was used to minimize the stone's retropulsion.

In group B (using a basket of wires3F) the helical type was passed through the four wires of the working channel of the ureteroscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as the control group. Ureteroscopic crushing was performed by a urologist in both groups under similar technical conditions. Findings during and after the completion of crushing include the success, stone retropulsion or parts larger than 3 mm, which requires secondary measures (SWL - ureter stenting, resection ureteroscopy), the duration of stone breakdown and traumatic ureteric complications in both groups it is registered.


Eligibility criteria: Inclusion Criteria:

* Individual interest in engaging in research
* Patients with ureter stones
* Symptoms of severe and resistant to supportive and therapeutic treatment
* Ureteral stones cause ureteral obstruction
* Ureteral stones, which is not likely to be disposed of by duration and size, have been selected for ureteroscopic lithotripsy.

Exclusion Criteria:

* Patients with urinary tract infection
* Not having a proper cardiovascular condition and not approved by a cardiologist or anesthetist
* Patients who are dissatisfied with ureteroscopic crushing and patients who do not have access to rocks during ureteroscopic surgery
* Individual interest in leaving the study

Primary outcomes:
measure: Stone size
timeFrame: 24 hours
measure: Crushing time
timeFrame: up to 23minute
measure: Demographic questionnaire
timeFrame: 24 hours
measure: Troma in the ureter area
timeFrame: up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: MS Bagheri-baghdasht
city: Tehran
country: Iran, Islamic Republic of
facility: MS bagheri-baghdast
Study officials:
References:
citation: Elashry OM, Tawfik AM. Preventing stone retropulsion during intracorporeal lithotripsy. Nat Rev Urol. 2012 Dec;9(12):691-8. doi: 10.1038/nrurol.2012.204. Epub 2012 Nov 20.
citation: Rane A, Bradoo A, Rao P, Shivde S, Elhilali M, Anidjar M, Pace K, D'A Honey JR. The use of a novel reverse thermosensitive polymer to prevent ureteral stone retropulsion during intracorporeal lithotripsy: a randomized, controlled trial. J Urol. 2010 Apr;183(4):1417-21. doi: 10.1016/j.juro.2009.12.023. Epub 2010 Feb 20.
citation: Vejdani K, Eisner BH, Pengune W, Stoller ML. Effect of laser insult on devices used to prevent stone retropulsion during ureteroscopic lithotripsy. J Endourol. 2009 Feb;23(2):249-51. doi: 10.1089/end.2008.0352.
citation: Ursiny M, Eisner BH. Cost-effectiveness of anti-retropulsion devices for ureteroscopic lithotripsy. J Urol. 2013 May;189(5):1762-6. doi: 10.1016/j.juro.2012.11.085. Epub 2012 Nov 15.
citation: Wu JA, Ngo TC, Hagedorn JC, Macleod LC, Chung BI, Shinghal R. The accordion antiretropulsive device improves stone-free rates during ureteroscopic laser lithotripsy. J Endourol. 2013 Apr;27(4):438-41. doi: 10.1089/end.2012.0332. Epub 2013 Feb 6.
citation: Pagnani CJ, El Akkad M, Bagley DH. Prevention of stone migration with the Accordion during endoscopic ureteral lithotripsy. J Endourol. 2012 May;26(5):484-8. doi: 10.1089/end.2011.0386. Epub 2012 Jan 4.
citation: Farahat YA, Elbahnasy AE, Elashry OM. A randomized prospective controlled study for assessment of different ureteral occlusion devices in prevention of stone migration during pneumatic lithotripsy. Urology. 2011 Jan;77(1):30-5. doi: 10.1016/j.urology.2010.05.063. Epub 2010 Oct 20.