Nephrolithiasis Staghorn Calculus, Safety Issues, Surgery-Complications
Conditions
Keywords
total tubeless PCNL, complication, safety, tubeless PCNL
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.
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.
Interventions
OTHERtotal tubeless mini-PCNL
When finish the mini-PCNL operation, patient not receive placement both ureteral drainage tube (DJ-stent) and nephrostomy tube.
OTHERtubeless mini-PCNL
When finish the mini-PCNL operation, patient receive placement ureteral drainage tube (DJ-stent) but not receive nephrostomy tube.
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Caregiver)
Masking description
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
Intervention model description
Randomized Controlled Trial in 2 group 1. total tubeless mini-PCNL 2. tubeless mini-PCNL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | surgical outcomes such as bleeding, post operative pain, length of hospital stay, stone free rate. |
Countries
Thailand
Contacts
Primary ContactTHANAKORN SIRAJARUS
Backup ContactChinnakhet Ketsuwan
Outcome results
None listed