Skip to main content
Clinical Trials/NCT03980444
NCT03980444CompletedNot Applicable

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

Mohammad Sadegh Bagheri Baghdasht2 sites in 1 country124 target enrollmentStarted: April 29, 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
124
Locations
2
Primary Endpoint
Stone size

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (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.

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

control group, no basket of wire

Experimental

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.

Intervention: control group, no basket (Procedure)

using a basket of wires

Sham Comparator

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: Basket of wire (Device)

Outcomes

Primary Outcomes

Stone size

Time Frame: 24 hours

The largest diameter of the stone in the imaging of millimeters

Crushing time

Time Frame: up to 23minute

Duration needed to break the stone to the minute

Demographic questionnaire

Time Frame: 24 hours

The demographic questionnaire was used to collect information

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Mohammad Sadegh Bagheri Baghdasht
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Mohammad Sadegh Bagheri Baghdasht

student research committee

Baqiyatallah Medical Sciences University

Study Sites (2)

Loading locations...

Similar Trials