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

Not Applicable

Not yet recruiting

• Conditions: Surgery-Complications; Nephrolithiasis Staghorn Calculus; Safety Issues
• Interventions: Other: total tubeless mini-PCNL; Other: tubeless mini-PCNL

• Registration Number: NCT06288022
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-02-24
• Study First Submitted QC: 2024-02-24
• Status Verified: 2024-03
• Study First Posted: 2024-03-01
• Last Update Submitted: 2024-03-05
• Last Update Posted: 2024-03-07
• Study Start: 2024-04-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 130

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
total tubeless mini-PCNL	total tubeless mini-PCNL	When finish the mini-PCNL operation, patient not receive placement both ureteral drainage tube (DJ-stent) and nephrostomy tube.
tubeless mini-PCNL	tubeless mini-PCNL	When finish the mini-PCNL operation, patient receive placement ureteral drainage tube (DJ-stent) but not receive nephrostomy tube.

Primary Outcome Measures

Name	Time	Method
incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL	from post operative day 0 to day 45	The main objective is to study the incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL

Secondary Outcome Measures

Name	Time	Method
The secondary objective is to assess the surgical outcomes between total tubeless mini-pcnl and tubeless mini-PCNL	from post operative day 0 to day 45	surgical outcomes such as bleeding, post operative pain, length of hospital stay, stone free rate.

Trial Locations

Locations (1)

Ramathibodi Hospital, Mahidol University; 🇹🇭 Bangkok, Ratchathewi, Thailand