NCT04153474

Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube?

Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube? Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Mansoura University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Regarding to the distribution of nephrostomy tube (NT) size usage by country. There was a clear distinction between countries that used solely the small bore (SB) NT (Chile and Australia) and those that used solely the large bore (LB) NT (Czech Republic and Japan). There is also a trend toward SB NT in North America (\~75% in USA and Canada) and toward LB NT in South America (\~80% in Argentina and Mexico). In Europe the trend is equal (\~50% in Germany, France, Greece and UK). Based on previous data and in view of conflicting data about postoperative complication including extravasation, bleeding and hemoglobin change and pain between previous studies, we will conduct this randomised trial comparing SB and LB NT following PNL. Our aim to evaluate the safety of small versus large bore NT reporting complications using the Clavien-Dindo system with categorisation of PNL-specific complications

Conditions

• Urolithiasis
• Nephrolithotomy
• Percutaneous Nephrolithotomy (PNL)
• Nephrostomy Tube (NT)
• Pain

Interventions

Type	Name	Description
PROCEDURE	large-bore nephrostomy tube (LBNT)	large-bore 22 french nephrostomy tube (LBNT)
PROCEDURE	small-bore nephrostomy tube (SBNT)	small-bore 14 french nephrostomy tube (SBNT)

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-02-01
• Completion: 2020-02-01
• First posted: 2019-11-06
• Last updated: 2019-11-06

Locations

1 site across 1 country: Egypt