Kidney Calculi, Nephrolithiasis
Conditions
Keywords
Percutaneous nephrolithotomy, Tubeless percutaneous nephrolithotomy, Conventional percutaneous nephrolithotomy, Glubran 2, Cyanoacrylate tissue adhesive, Percutaneous tract sealing, Nephrostomy tube, Kidney stones, Renal calculi, Stone-free rate, Postoperative pain, Postoperative bleeding
Brief summary
This prospective randomized controlled study will compare two techniques used after percutaneous nephrolithotomy, a procedure for removing kidney stones. Participants with renal stones measuring 2-3 cm will be randomly assigned to either tubeless percutaneous nephrolithotomy with nebulized Glubran 2 used to seal the access tract or conventional percutaneous nephrolithotomy with placement of a nephrostomy tube. The study will evaluate whether the Glubran 2-assisted tubeless technique is safe and effective and whether it can reduce postoperative pain, bleeding, hospital stay, urine leakage, and other complications while maintaining a satisfactory stone-free rate.
Interventions
PROCEDURENebulized Glubran 2-Assisted Tubeless PCNL
Following stone removal by percutaneous nephrolithotomy, 1 mL of Glubran 2 will be nebulized into the percutaneous access tract using a special applicator under endoscopic and fluoroscopic guidance. The tract will be temporarily occluded using a 16 Fr Foley catheter balloon, and no nephrostomy tube will be placed.
PROCEDUREConventional PCNL With Nephrostomy Tube
Following stone removal by percutaneous nephrolithotomy, a 24 Fr Nelaton tube will be placed as a nephrostomy tube for postoperative drainage and will generally be removed after approximately 24 hours according to the participant's clinical condition.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned in parallel to either nebulized Glubran 2-assisted tubeless percutaneous nephrolithotomy or conventional percutaneous nephrolithotomy with nephrostomy tube placement.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * Single or multiple renal stones measuring 2-3 cm. * Renal stones located in an anatomical position suitable for percutaneous nephrolithotomy. * Participant considered suitable for PCNL under general anesthesia. * Ability and willingness to provide written informed consent.
Exclusion criteria
* Active urinary tract infection. * Renal stones in an anomalous kidney. * Uncontrolled hypertension. * Uncontrolled diabetes mellitus. * Uncorrected coagulopathy. * Clinically significant arrhythmia. * Distal ureteric obstruction. * Fixed hip joints preventing appropriate operative positioning. * Previous renal surgery. * Requirement for more than one percutaneous puncture. * Pelvicalyceal system perforation during the procedure. * Excessive intraoperative bleeding. * Any intraoperative finding requiring nephrostomy tube placement for safety.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity | Within the first 24 hours after surgery | Postoperative pain will be assessed using the Visual Analog Scale, ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Scores will be compared between the nebulized Glubran 2-assisted tubeless PCNL group and the conventional PCNL group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone-Free Rate | At 24 hours after surgery | The proportion of participants with no clinically significant residual renal stones on postoperative imaging will be compared between the two study groups. |
| Postoperative Hemoglobin Change | From baseline before surgery to 24 hours after surgery | The change in hemoglobin concentration will be calculated as the preoperative hemoglobin value minus the postoperative hemoglobin value, measured in g/dL. |
| Blood Transfusion Requirement | From the end of surgery through 24 hours after surgery | The proportion of participants requiring packed red blood cell transfusion after the procedure. |
| Urinary Leakage | From the end of surgery through 48 hours after surgery | The proportion of participants developing clinically evident urine leakage from the percutaneous access site. |
| Length of Hospital Stay | From the end of surgery through 30 days after surgery | The proportion of participants experiencing postoperative complications, including bleeding, fever, urinary leakage, infection, or need for an additional intervention. |
| Intraoperative Blood Loss | Intraoperatively | Estimated blood loss during the surgical procedure will be recorded in milliliters. |
| Fluoroscopy Exposure Time | Intraoperatively | The cumulative duration of fluoroscopic exposure will be recorded in seconds. |
Countries
Egypt
Contacts
CONTACTSaad A Salama, MD
Outcome results
None listed