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Disposable Versus Disposable Nephroscope During PCNLs: a Feasibility RCT

ConditionStone, Kidney
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-99
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

A feasibility randomised controlled trials comparing re-usable versus disposable nephroscope when treating kidney stones during mini-PCNLs

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing mini PCNL to treat renal stones with a cumulative stone diameter 2-5 cm and completing at least a 3 month's follow-up

Cases performed by surgeons beyond their learning curves

Patients aged > 18

Unenhanced CT scan carried out within 3 months pre-operatively

Disqualifiers

PCNL performed for proximal ureteric stones

Urinary tract with abnormal anatomy

Obese patients

ASA>3

Trial design

Design model

Parallel

Treatments tested in this trial

  • Disposable mini-PCNL

    Procedure/Surgery

    Mini-PCNL carried out using disposable scope

  • Re-usable mini-PCNL

    Procedure/Surgery

    Mini-PCNL carried out using re-usable scope

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Mini-PCNL with disposable scopeExperimental treatment 1 intervention
Group B: Mini-PCNL using re-usable scopeActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Stone free rate

ability of used scope in determining a complete stone clearance, or absence of clinically significant residual fragments

Time frame
90 days post-op

Secondary outcomes

1

complication rate

presence of post-operative complications according to Calvin-Dindo classification system

Time frame
30 days post-op
2

adequacy of used instrument

adequacy of instruments (including failure, quality of view, handling) will be tested

Time frame
intra-operative assessment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The First Affiliated Hospital of Guangzhou Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: