Effectiveness Basket Wires for the Maintenance of Stone and Pneumatic Probe in the Treatment of Ureteral Stones

Ureter Stone Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03980444
• Other study ID #: IR.BMSU.REC.1393.4
• Status: Completed
• Phase: N/A
• Start date: April 29, 2015
• Est. completion date: April 20, 2018

Study information

• Verified date: June 2019
• Source: Baqiyatallah Medical Sciences University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: April 20, 2018
• Est. primary completion date: January 18, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Ureter Stone
• Ureteral Calculi
• Ureterolithiasis

Intervention

Device:
• Basket of wire
(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 probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as control group. Urethroscopic 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

Procedure:
• control group, no basket
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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	MS Bagheri-baghdasht	Tehran
Iran, Islamic Republic of	MS bagheri-baghdast	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Mohammad Sadegh Bagheri Baghdasht

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (7)

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. Review. — View 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 — View 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. — View 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;1 — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone size	The largest diameter of the stone in the imaging of millimeters	24 hours
Primary	Crushing time	Duration needed to break the stone to the minute	up to 23minute
Primary	Demographic questionnaire	The demographic questionnaire was used to collect information	24 hours
Primary	Troma in the ureter area	Follow up of patients for perforation, missing stone, and ureter ligation according to observations during and after surgery	up to 24 hours