Nebulized Glubran 2-Assisted Tubeless PCNL Versus Conventional PCNL

N/ANot Yet RecruitingNCT07749807

Benha University100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Kidney Calculi Nephrolithiasis

Interventions

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.

Conventional PCNL With Nephrostomy TubePROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 surgery

Secondary Outcomes

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 surgery

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 surgery

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 surgery

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 surgery

Length of Hospital Stay

The proportion of participants experiencing postoperative complications, including bleeding, fever, urinary leakage, infection, or need for an additional intervention.

Time frame: From the end of surgery through 30 days after surgery

Intraoperative Blood Loss

Estimated blood loss during the surgical procedure will be recorded in milliliters.

Time frame: Intraoperatively

Fluoroscopy Exposure Time

The cumulative duration of fluoroscopic exposure will be recorded in seconds.