Comparative Study Between One-Shot Dilatation Versus Serial Dilatation Techniques for Access in Percutaneous Nephrolithotomy in Adult Patients

Ain Shams University60 enrolled

Overview

This comparative study aims to compare and assess the safety, efficacy, outcome, feasibility, intraoperative and postoperative complications of one-shot dilatation versus serial dilatation techniques for access during percutaneous nephrolithotomy for management of renal stone disease in adult patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Percutaneous Nephrolithotomy (PCNL)Renal Stone Disease

Interventions

renal dilatation by one-shot dilatation techniquePROCEDURE

renal dilatation was done by one-shot dilatation technique using 30Fr Amplatz dilator directly over the central Alken rod.

renal dilatation by metallic telescopic dilators (Alken).PROCEDURE

insertion of the Alken guide followed by a telescopic dilator between 9Fr to 30Fr, then an Amplatz sheath 30Fr was advanced over the dilator which was then removed, leaving the Amplatz sheath in the collecting system

renal dilatation by sequential fascial dilators (Amplatz)PROCEDURE

sequential renal dilatation with Amplatz dilator set was used

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients aged between 18 and 70 years. * Patients with renal stones which their size in maximum diameter is more than 2cm and indicated for percutaneous nephrolithotomy. * Patients clinically fit for surgery. * Patients with normal anatomy of urinary tract. * Patients able to understand the procedure and accept to sign the informed consent. Exclusion Criteria: * Patients aged below 18 or above 70 years. * Patients with renal stones which their size in maximum diameter is less than 2cm or contraindicated for endoscopic management. * Patients with urinary tract infection, abnormal coagulopathy state or clinically unfit for surgery. * Patients with nephrostomy tube in situ. * Patients with more than single access tract. * Patients undergoing simultaneous bilateral stone procedures. * Patients with urinary tract abnormalities or history of renal transplantation. * Renal insufficiency with serum creatinine above 3.0mg/dL * Patients unable to understand the procedure or refuse to sign the informed consent.

Locations (1)

Ain Shams University

Cairo, Cairo Governorate, Egypt

Outcomes

Primary Outcomes

Mean Fluoroscopy time

Time frame: From enrollment to the end of treatment at 8 weeks

Mean access time

Time frame: From enrollment to the end of treatment at 8 weeks

Stone free rate

Time frame: From enrollment to the end of treatment at 8 weeks

Hospitalization Period

Time frame: From enrollment to the end of treatment at 8 weeks

Data from ClinicalTrials.gov

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