Pediatric Kidney Disease Clinical Trial
Official title:
Ultrasonic Versus Fluoroscopic Guided Percutaneous Nephrolithotripsy in Pediatric Renal Stones: a Prospective Randomized Study
Percutaneous Nephrolithotomy (PNL) was accepted as a treatment modality for large renal stones since 1980. Although radiation exposure during PNL is within the safe limits for expert endourologist, the mutagenic hazard is still present especially in pediatric population. Therefore, employing an alternative imaging technique during PNL would be of added advantage. So, the investigators want to compare the efficacy of ultrasound guided PNL with the conventional (fluoroscopy guided) PNL in pediatric population. If ultrasound guided PNL was as effective as conventional one, this means that many children could be protected from the variable hazards of radiation exposure.
Status | Recruiting |
Enrollment | 6 |
Est. completion date | May 2022 |
Est. primary completion date | March 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 14 Years |
Eligibility | Inclusion Criteria: - All kidney stones in pediatric age group and indicated for PNL. Exclusion Criteria: - Children unfit for the procedure or non indicated for it. - Parental refusal. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of medicine-Assiut university | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Zeng G, Zhao Z, Wan S, Zhong W, Wu W. Comparison of children versus adults undergoing mini-percutaneous nephrolithotomy: large-scale analysis of a single institution. PLoS One. 2013 Jun 24;8(6):e66850. doi: 10.1371/journal.pone.0066850. Print 2013. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stone free rate. | Stone free rate (less than 4 mm residual is considered free). | Day one post operative. | |
Secondary | The need for blood transfusion. | Amount of transfused blood (if any) in milliliters. | within 24 hours of the procedure. | |
Secondary | Surrounding organ injury. | Any injured surrounding organ e.g. liver, spleen or lung will be recorded with the degree of injury. | within first 24 hours post operative. | |
Secondary | Radiation exposure. | Amount of radiation exposure (during fluoroscopy guided PNL) in millisievert (mSv). | within one hour during the procedure. |
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