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Transurethral Versus Percutaneous Endoscopic Management of Bladder Stones in Boys

NCT03294239 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-09-01

No results posted yet for this study

Summary

To compare safety and efficacy of trans urethral and per cutaneous approaches in endoscopic management of bladder stones in boys younger than 14 years

Conditions

  • Pediatric Bladder Stones

Interventions

PROCEDURE

Transurethral extraction of bladder stone(s)

Patients will have transurethral approach for management of their bladder stones. Either pneumatic or Holmium:YAG laser will be used for stone distentegration. Stone basket and/or Elics current evacuation will be used to retrieve stone fragments. Urethral catheter will be applied for 48 hours.

PROCEDURE

percutaneous extraction of bladder stone(s)

Patients will have percutaneous approach for management of their bladder stones. After initial cystoscopy a Foley's urethral catheter will be fixed for continuous irrigation. Then, the bladder will be filled to capacity with normal saline. Access to the distended bladder will be obtained by 10-gauge needle in the midline 1-2 cm above the pubic bone. Once suitable placement is confirmed with return of fluid, a guide wire will be passed through the needle into the bladder. Dilatation will be done using 8-10 Fr coaxial dilators then single fascial dilator with placement of 16 Fr Amplatz sheath as a working tract. No ultrasonic or fluoroscopic guidance will be used. Stone basket will be used to extract the stone. If the stones were larger than the used sheath, disintegration will be performed with a pneumatic lithotrite. Primary skin closure of the suprapubic stab wound by one stitch will be done and the urethral catheter will remain for 48 hours.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
14 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2020-08-01
Completion
2020-09-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03294239 on ClinicalTrials.gov