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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05855057
Other study ID # RC 14-4-2023
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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