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Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL

M

Mahidol University

Status

Not yet enrolling

Conditions

Surgery-Complications
Safety Issues
Nephrolithiasis Staghorn Calculus

Treatments

Other: tubeless mini-PCNL
Other: total tubeless mini-PCNL

Study type

Interventional

Funder types

Other

Identifiers

NCT06288022
COA. MURA2023/947

Details and patient eligibility

About

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.

Full description

After being informed about study and potential risks, all patient giving written informed consent with undergo a mini-PCNL operation. Patient who meet the eligibility requirements will be randomized in a single-blind manner (patient) in a 1:1 ratio to total tubeless mini-PCNL or tubeless mini-PCNL.

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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
  • No coagulopathy

Exclusion criteria

  • Presence of residual stones after the surgery, fragments larger than 4 millimeters.

  • Patients with a single functioning kidney

  • Complicated cases, including:

    1. massive bleeding in the upper tract during surgery
    2. Severe collecting systems injury during surgery
    3. Severe UPJ mucosa swelling considered unsafe by the physician, requiring the placement of a DJ stent or nephostomy tube
  • Participants who decline or request withdrawal from the research study.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

130 participants in 2 patient groups

total tubeless mini-PCNL
Experimental group
Description:
When finish the mini-PCNL operation, patient not receive placement both ureteral drainage tube (DJ-stent) and nephrostomy tube.
Treatment:
Other: total tubeless mini-PCNL
tubeless mini-PCNL
Active Comparator group
Description:
When finish the mini-PCNL operation, patient receive placement ureteral drainage tube (DJ-stent) but not receive nephrostomy tube.
Treatment:
Other: tubeless mini-PCNL

Trial contacts and locations

1

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Central trial contact

Chinnakhet Ketsuwan; THANAKORN SIRAJARUS

Data sourced from clinicaltrials.gov

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