Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMahidol University
About this trial
Limited literature has focused on the use of totally tubeless mini-percutaneous nephrolithotomy (Mini-PCNL) for the treatment of large renal stones.
This Randomized Controlled trial aims to compare complication and safety of Mini-PCNL between total tubeless and tubeless Mini-PCNL.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with kidney stones with a size ranging from 20 to 40 millimeters.
Patients have undergone mini-PCNL, unilateral
Absence of urinary tract infections before surgery.
No urological congenital abnormality
Disqualifiers
Presence of residual stones after the surgery, fragments larger than 4 millimeters.
Patients with a single functioning kidney
massive bleeding in the upper tract during surgery
Severe collecting systems injury during surgery
Trial design
Design model
Parallel
Treatments tested in this trial
total tubeless mini-PCNL
Other interventionWhen finish the mini-PCNL operation, patient not receive placement both ureteral drainage tube (DJ-stent) and nephrostomy tube.
tubeless mini-PCNL
Other interventionWhen finish the mini-PCNL operation, patient receive placement ureteral drainage tube (DJ-stent) but not receive nephrostomy tube.
Treatment groups
130 Participants
are divided into 2 treatment groupsGroup A: total tubeless mini-PCNLExperimental treatment 1 intervention
Group B: tubeless mini-PCNLActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL
The main objective is to study the incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL
Time frame
from post operative day 0 to day 45Secondary outcomes
1
The secondary objective is to assess the surgical outcomes between total tubeless mini-pcnl and tubeless mini-PCNL
surgical outcomes such as bleeding, post operative pain, length of hospital stay, stone free rate.
Time frame
from post operative day 0 to day 45Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: