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

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

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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