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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| total tubeless mini-PCNL | Experimental | When finish the mini-PCNL operation, patient not receive placement both ureteral drainage tube (DJ-stent) and nephrostomy tube. |
|
| tubeless mini-PCNL | Active Comparator | When finish the mini-PCNL operation, patient receive placement ureteral drainage tube (DJ-stent) but not receive nephrostomy tube. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| total tubeless mini-PCNL | Other | When finish the mini-PCNL operation, patient not receive placement both ureteral drainage tube (DJ-stent) and nephrostomy tube. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| THANAKORN SIRAJARUS | Contact | 086-599-3259 | thanakorn.sjr@gmail.com | |
| Chinnakhet Ketsuwan | Contact | 086-345-6901 | chinnakhet.ket@mahidol.ac.th |
| Name | Affiliation | Role |
|---|---|---|
| THANAKORN SIRAJARUS | Ramathibodi Hospital, Mahidol University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramathibodi Hospital, Mahidol University | Bangkok | Ratchathewi | 10400 | Thailand |
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| ID | Term |
|---|---|
| D000069856 | Staghorn Calculi |
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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Randomized Controlled Trial in 2 group
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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
| tubeless mini-PCNL | Other | When finish the mini-PCNL operation, patient receive placement ureteral drainage tube (DJ-stent) but not receive nephrostomy tube. |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |