Nebulized Glubran 2-Assisted Tubeless PCNL Versus Conventional PCNL
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBenha University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Active urinary tract infection.
Renal stones in an anomalous kidney.
Uncontrolled hypertension.
Uncontrolled diabetes mellitus.
Trial design
Design model
Parallel
Treatments tested in this trial
Nebulized Glubran 2-Assisted Tubeless PCNL
Procedure/SurgeryFollowing 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.
Conventional PCNL With Nephrostomy Tube
Procedure/SurgeryFollowing 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Nebulized Glubran 2-Assisted Tubeless PCNLExperimental treatment 1 intervention
Group B: Conventional PCNL With Nephrostomy TubeActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative Pain Intensity
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.
Time frame
Within the first 24 hours after surgerySecondary outcomes
1
Stone-Free Rate
The proportion of participants with no clinically significant residual renal stones on postoperative imaging will be compared between the two study groups.
Time frame
At 24 hours after surgery2
Postoperative Hemoglobin Change
The change in hemoglobin concentration will be calculated as the preoperative hemoglobin value minus the postoperative hemoglobin value, measured in g/dL.
Time frame
From baseline before surgery to 24 hours after surgery3
Blood Transfusion Requirement
The proportion of participants requiring packed red blood cell transfusion after the procedure.
Time frame
From the end of surgery through 24 hours after surgery4
Urinary Leakage
The proportion of participants developing clinically evident urine leakage from the percutaneous access site.
Time frame
From the end of surgery through 48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov
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