UnknownNot Applicable

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

Egypt220 participantsStarted 2019-05-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Staghorn calculi
. Renal pelvis stones =\>2 cm
. Lower pole stones= \>1.5 cm
. upper ureteral calculi =\>1.5 cm
. SWL-resistant stones

Exclusion criteria

. Age \<18 years or Pregnancy
. Tubeless PNL
. Need for 3 percutaneous tracts intraoperative

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of hemoglobin reduction difference between groups

Timeframe: 8 months

Trial details

NCT IDNCT04153474

SponsorMansoura University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-01

View on ClinicalTrials.gov More Urolithiasis trials