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

Safety Issues Clinical Trial

Official title:

Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL : A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06288022
• Other study ID #: COA. MURA2023/947
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: June 30, 2026

Study information

• Verified date: March 2024
• Source: Mahidol University
• Contact: THANAKORN SIRAJARUS
• Phone: 086-599-3259
• Email: thanakorn.sjr[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: June 30, 2026
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis
• Safety Issues

Intervention

Other:
• 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
When finish the mini-PCNL operation, patient receive placement ureteral drainage tube (DJ-stent) but not receive nephrostomy tube.

Locations

Country	Name	City	State
Thailand	Ramathibodi Hospital, Mahidol University	Bangkok	Ratchathewi

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	from post operative day 0 to day 45
Secondary	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.	from post operative day 0 to day 45