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

NCT ID: NCT03980444

Last Updated: 2019-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-29

Study Completion Date

2018-04-20

Brief Summary

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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.

Detailed Description

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Conditions

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Ureter Stone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

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control group, no basket of wire

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.

Group Type EXPERIMENTAL

control group, no basket

Intervention Type PROCEDURE

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.

using a basket of wires

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 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

Group Type SHAM_COMPARATOR

Basket of wire

Intervention Type DEVICE

(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

Interventions

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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

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mohammad Sadegh Bagheri Baghdasht

OTHER

Sponsor Role lead

Responsible Party

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Mohammad Sadegh Bagheri Baghdasht

student research committee

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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MS Bagheri-baghdasht

Tehran, , Iran

Site Status

MS bagheri-baghdast

Tehran, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type RESULT
PMID: 23165399 (View on PubMed)

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.

Reference Type RESULT
PMID: 20171695 (View on PubMed)

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.

Reference Type RESULT
PMID: 19220084 (View on PubMed)

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.

Reference Type RESULT
PMID: 23159589 (View on PubMed)

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.

Reference Type RESULT
PMID: 23387558 (View on PubMed)

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.

Reference Type RESULT
PMID: 22192096 (View on PubMed)

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.

Reference Type RESULT
PMID: 20970173 (View on PubMed)

Other Identifiers

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IR.BMSU.REC.1393.4

Identifier Type: -

Identifier Source: org_study_id

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