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

NCT ID: NCT06288022

Last Updated: 2024-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgery-Complications Nephrolithiasis Staghorn Calculus Safety Issues

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial in 2 group

1. total tubeless mini-PCNL
2. tubeless mini-PCNL
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers
All eligible patients will be provided with an explanation of the research and invited to participate.

Patient will participate or not depends on whether they not meet the surgical exclusion criteria. If they meet the criteria, they will not participate in the research. If they not meet the criteria, they will be randomly assigned to one of the groups.

Patients will not be informed of the treatment intervention in advance

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

total tubeless mini-PCNL

When finish the mini-PCNL operation, patient not receive placement both ureteral drainage tube (DJ-stent) and nephrostomy tube.

Group Type EXPERIMENTAL

total tubeless mini-PCNL

Intervention Type OTHER

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.

Group Type ACTIVE_COMPARATOR

tubeless mini-PCNL

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

total tubeless mini-PCNL

When finish the mini-PCNL operation, patient not receive placement both ureteral drainage tube (DJ-stent) and nephrostomy tube.

Intervention Type OTHER

tubeless mini-PCNL

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mahidol University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Thanakorn Sirajarus

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

THANAKORN SIRAJARUS

Role: PRINCIPAL_INVESTIGATOR

Ramathibodi Hospital, Mahidol University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ramathibodi Hospital, Mahidol University

Bangkok, Ratchathewi, Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

THANAKORN SIRAJARUS

Role: CONTACT

086-599-3259

Chinnakhet Ketsuwan

Role: CONTACT

086-345-6901

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Thanakorn Sirajarus

Role: primary

086-599-3259

Chinnakhet Ketsuwan

Role: backup

086-345-6901

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COA. MURA2023/947

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.