Effectiveness of US-Guided PCNL Different Positions in Renal Stones Treatment

Ultrasound Therapy; Complications Clinical Trial

Official title:

A Retrospective Single Centered Cohort Study Comparing The Effectiveness of Ultrasound-Guided PCNL Different Positions in Renal Stones Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05855057
• Other study ID #: RC 14-4-2023
• Status: Completed
• Start date: January 20, 2018
• Est. completion date: January 20, 2022

Study information

• Verified date: May 2023
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to compare the effectiveness of Ultrasound-Guided Percutaneous nephrolithotomyin different positions supine, prone positions and flank suspend supine position in renal stones treatment.

Description:

Percutaneous nephrolithotomy (PCNL) has become the choice of modality for the treatment of large and complicated renal calculi. Initially, percutaneous access to the kidney was only performed in the prone position, as described sixty years ago.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: January 20, 2022
• Est. primary completion date: January 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• patients who underwent Percutaneous nephrolithotomy

• Patient's age from >18 - 70 years old.

• Body mass index (30-40 kg/m2).

• Both sex

• Renal stones diameter =2 cm

• Cardiac patients

Exclusion Criteria:

• Patient refusal.

• Pregnant women.

• Patients with renal anomalies.

• Transplanted kidney.

• Uncorrected coagulopathy, or active infection.

Related Conditions & MeSH terms

• Kidney Calculi
• Nephrolithiasis
• Percutaneous Nephrolithotomy
• Renal Stones
• Ultrasound Therapy; Complications

Intervention

Procedure:
• Flank suspended supine position percutaneous nephrolithotomy
The patients will be placed in the supine position with the shoulder and the buttock will be raised by a 3-l bag of water suspending the flank of the affected side. The body contour will be aligned to the edge of the table. The operating table will be adjusted to the jack knife position, with the tip of the lower part of the table will be slightly lowered. The leg of the affected side of the patent will be straightened dorsally flexed and slightly inner rotated, with the knee of the other side will be flexed. The patients will be then immobilized at the chest and the pelvis with two adherent tapes which crossed each other at the abdomen to form a 'V' shape.
• Supine percutaneous nephrolithotomy group
The patient will remain in the supine position, with the side of interest at the edge of the table, with a small cushion placed under the flank to elevate it 15-20°.
• Prone percutaneous nephrolithotomy group
Prone percutaneous nephrolithotomy. The prone position (PRON) technique followed these classic steps: patients will be placed in a lithotomy position and a ureteral catheter will be inserted through a rigid cystoscope to perform a retrograde pyelogram. The ureteral catheter will be fixed to a Foley catheter, and then the patient will be repositioned to the prone position with pads under their shoulders.

Locations

Country	Name	City	State
Egypt	Benha University Hospitals	Benha

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stone clearance rate	Comparison of stone clearance rates among different positions (flank suspended supine, supine, and prone) in Ultrasound-Guided Percutaneous Nephrolithotomy (PCNL) for the treatment of renal stones.	3 months postoperatively
Secondary	Operative time	duration of the Ultrasound-Guided Percutaneous Nephrolithotomy (PCNL) procedure among different positions	Intraoperatively
Secondary	Complication rates	Comparison of postoperative complications (e.g., bleeding, infection, injury) among the different positions.	48 hours Postoperatively
Secondary	Stone-free rates	Comparison of the percentage of patients achieving complete stone clearance among the different positions.	48 hours Postoperatively