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

Primary Purpose

Ureter Stone

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Basket of wire
control group, no basket
Sponsored by
Mohammad Sadegh Bagheri Baghdasht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ureter Stone focused on measuring Ureterolithiasis, Manganese Poisoning, Lithotripsy, Ureteroscopy, stone baske

Eligibility Criteria

30 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MS Bagheri-baghdasht
  • MS bagheri-baghdast

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

control group, no basket of wire

using a basket of wires

Arm Description

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 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

Outcomes

Primary Outcome Measures

Stone size
The largest diameter of the stone in the imaging of millimeters
Crushing time
Duration needed to break the stone to the minute
Demographic questionnaire
The demographic questionnaire was used to collect information
Troma in the ureter area
Follow up of patients for perforation, missing stone, and ureter ligation according to observations during and after surgery

Secondary Outcome Measures

Full Information

First Posted
June 4, 2019
Last Updated
June 6, 2019
Sponsor
Mohammad Sadegh Bagheri Baghdasht
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1. Study Identification

Unique Protocol Identification Number
NCT03980444
Brief Title
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

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
April 29, 2015 (Actual)
Primary Completion Date
January 18, 2017 (Actual)
Study Completion Date
April 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Mohammad Sadegh Bagheri Baghdasht

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ureter Stone
Keywords
Ureterolithiasis, Manganese Poisoning, Lithotripsy, Ureteroscopy, stone baske

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control group, no basket of wire
Arm Type
Experimental
Arm Description
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.
Arm Title
using a basket of wires
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Basket of wire
Intervention Description
(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
Procedure
Intervention Name(s)
control group, no basket
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stone size
Description
The largest diameter of the stone in the imaging of millimeters
Time Frame
24 hours
Title
Crushing time
Description
Duration needed to break the stone to the minute
Time Frame
up to 23minute
Title
Demographic questionnaire
Description
The demographic questionnaire was used to collect information
Time Frame
24 hours
Title
Troma in the ureter area
Description
Follow up of patients for perforation, missing stone, and ureter ligation according to observations during and after surgery
Time Frame
up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
MS Bagheri-baghdasht
City
Tehran
Country
Iran, Islamic Republic of
Facility Name
MS bagheri-baghdast
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23165399
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.
Results Reference
result
PubMed Identifier
20171695
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.
Results Reference
result
PubMed Identifier
19220084
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.
Results Reference
result
PubMed Identifier
23159589
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.
Results Reference
result
PubMed Identifier
23387558
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.
Results Reference
result
PubMed Identifier
22192096
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.
Results Reference
result
PubMed Identifier
20970173
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.
Results Reference
result

Learn more about this trial

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

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