Surgery-ComplicationsNCT06288022
Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL
A study testing total tubeless mini-PCNL and tubeless mini-PCNL in people with Surgery-Complications and Nephrolithiasis Staghorn Calculus, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery-Complications, Nephrolithiasis Staghorn Calculus, Safety Issues
- What is being tested?
- total tubeless mini-PCNL and tubeless mini-PCNL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteThailand
- Study dates
- 1 Apr 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Ramathibodi Hospital, Mahidol University
Bangkok, Ratchathewi, 10400
Thanakorn Sirajarus, 086-599-3259, Thanakorn.sjr@gmail.com
Chinnakhet Ketsuwan, 086-345-6901, chinnakhet.ket@mahidol.ac.th
About this study
Official title: 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.
Read the 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.
- Being tested
- total tubeless mini-PCNL, tubeless mini-PCNL
- Keywords
- total tubeless PCNL, complication, safety, tubeless PCNL
- Medical subject headings
- Staghorn Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total tubeless mini-PCNLOther
When finish the mini-PCNL operation, patient not receive placement both ureteral drainage tube (DJ-stent) and nephrostomy tube.
tubeless mini-PCNLOther
When finish the mini-PCNL operation, patient receive placement ureteral drainage tube (DJ-stent) but not receive nephrostomy tube.
| Study group | Role | What they receive |
|---|---|---|
| total tubeless mini-PCNL | Experimental | When finish the mini-PCNL operation, patient not receive placement both ureteral drainage tube (DJ-stent) and nephrostomy tube. Receives: 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. Receives: Other: tubeless mini-PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
surgical outcomes such as bleeding, post operative pain, length of hospital stay, stone free rate.
Measured: from post operative day 0 to day 45
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery-ComplicationsStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial in 2 group 1. total tubeless mini-PCNL 2. tubeless mini-PCNL
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanakorn Sirajarus, Mahidol University
- Investigators
- THANAKORN SIRAJARUS, Principal investigator, Ramathibodi Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06288022
- Sponsor's protocol ID
- COA. MURA2023/947
- Status last verified
- Mar 2024
- First submitted
- 24 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06288022
- Acronym / sponsor ID
- COA. MURA2023/947
- Keywords
- total tubeless PCNL, complication, safety, tubeless PCNL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial in 2 group 1. total tubeless mini-PCNL 2. tubeless mini-PCNL
| Arm | Type | Receives |
|---|---|---|
| total tubeless mini-PCNL | Experimental | Other: total tubeless mini-PCNLWhen finish the mini-PCNL operation, patient not receive placement both ureteral drainage tube (DJ-stent) and nephrostomy tube. |
| tubeless mini-PCNL | Active comparator | Other: tubeless mini-PCNLWhen finish the mini-PCNL operation, patient receive placement ureteral drainage tube (DJ-stent) but not receive nephrostomy tube. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- Presence of residual stones after the surgery, fragments larger than 4 millimeters.
- Patients with a single functioning kidney
- Complicated cases, including:
- Participants who decline or request withdrawal from the research study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total tubeless mini-PCNLWhen 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-PCNLWhen finish the mini-PCNL operation, patient receive placement ureteral drainage tube (DJ-stent) but not receive nephrostomy tube. | Other | tubeless mini-PCNL |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
THANAKORN SIRAJARUS principal investigator
Ramathibodi Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total tubeless mini-PCNL and tubeless mini-PCNL in people with Surgery-Complications and Nephrolithiasis Staghorn Calculus, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact THANAKORN SIRAJARUS (086-599-3259, thanakorn.sjr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL (time frame: from post operative day 0 to day 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2024.