NCT06288022

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress94%
Apr 2024Jun 2026

First Submitted

Initial submission to the registry

February 24, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

2.1 years

First QC Date

February 24, 2024

Last Update Submit

March 5, 2024

Conditions

Surgery-ComplicationsNephrolithiasis Staghorn CalculusSafety Issues

Keywords

total tubeless PCNLcomplicationsafetytubeless PCNL

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

total tubeless mini-PCNL

EXPERIMENTAL

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

Other: total tubeless mini-PCNL

tubeless mini-PCNL

ACTIVE COMPARATOR

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

Other: tubeless mini-PCNL

Interventions

total tubeless mini-PCNLOTHER

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

total tubeless mini-PCNL
tubeless mini-PCNLOTHER

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

tubeless mini-PCNL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Presence of residual stones after the surgery, fragments larger than 4 millimeters.
  • Patients with a single functioning kidney
  • Complicated cases, including:
  • massive bleeding in the upper tract during surgery
  • Severe collecting systems injury during surgery
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramathibodi Hospital, Mahidol University

Bangkok, Ratchathewi, 10400, Thailand

Location

MeSH Terms

Conditions

Staghorn Calculi

Condition Hierarchy (Ancestors)

Kidney CalculiNephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • THANAKORN SIRAJARUS

    Ramathibodi Hospital, Mahidol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

THANAKORN SIRAJARUS

CONTACT

086-599-3259thanakorn.sjr@gmail.com

Chinnakhet Ketsuwan

CONTACT

086-345-6901chinnakhet.ket@mahidol.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
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
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial in 2 group 1. total tubeless mini-PCNL 2. tubeless mini-PCNL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2024

First Posted

March 1, 2024

Study Start

April 1, 2024

Primary Completion

April 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 7, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)