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Completed

NCT Number: NCT03980444

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

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.

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Key information

Age range

30 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MS Bagheri-baghdasht, Tehran, Iran

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basket of wire

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

control group, no basket

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.

Primary outcomes

  1. Stone size

    Time frame: 24 hours

    The largest diameter of the stone in the imaging of millimeters

  2. Crushing time

    Time frame: up to 23minute

    Duration needed to break the stone to the minute

  3. Demographic questionnaire

    Time frame: 24 hours

    The demographic questionnaire was used to collect information

  4. Troma in the ureter area

    Time frame: up to 24 hours

    Follow up of patients for perforation, missing stone, and ureter ligation according to observations during and after surgery

Sponsors and collaborators

Lead sponsor

Mohammad Sadegh Bagheri Baghdasht

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 10, 2019
Registry last updated
Jun 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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