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

Ain Shams University

Status: Completed

Conditions: Renal Stone Disease; Percutaneous Nephrolithotomy (PCNL)

Treatments: Procedure: renal dilatation by metallic telescopic dilators (Alken).; Procedure: renal dilatation by sequential fascial dilators (Amplatz); Procedure: renal dilatation by one-shot dilatation technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07279389

FMASU MS133/2022

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Patients receiving renal dilatation by one-shot dilatation technique

Active Comparator group

Description:

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

Treatment:

Procedure: renal dilatation by one-shot dilatation technique

Patients receiving renal dilatation by metallic telescopic dilators (Alken).

Active Comparator group

Treatment:

Procedure: renal dilatation by metallic telescopic dilators (Alken).

Patients receiving renal dilatation by sequential fascial dilators (Amplatz).

Active Comparator group

Treatment:

Procedure: renal dilatation by sequential fascial dilators (Amplatz)