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

March 5, 2024 updated by: Thanakorn Sirajarus, Mahidol University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL
Time Frame: 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
from post operative day 0 to day 45

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: THANAKORN SIRAJARUS, Ramathibodi Hospital, Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

February 24, 2024

First Submitted That Met QC Criteria

February 24, 2024

First Posted (Actual)

March 1, 2024

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COA. MURA2023/947

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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