Triangulation Bulls Eye and Stone Direct Targeting Pcnl

Endourology Clinical Trial

Official title:

Triangulation, Eye of the Needle and Stone Direct Targeting Percutaneous Renal Access Techniques of Nephrolithotomy : Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04846699
• Other study ID #: new pcnl approch
• Status: Not yet recruiting
• Start date: April 20, 2021
• Est. completion date: April 20, 2023

Study information

• Verified date: April 2021
• Source: Assiut University
• Contact: mahmoud abdo eldardery
• Phone: 01008763519
• Email: m.eldardery91[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To assess the impact of percutaneous renal access technique on outcomes of percutaneous nephrolithotomy in management of renal stones by comparing the Triangulation and ''eye of the needle'' (or bull's eye) and the stone targeted techniques in the following:-

1. Stone free rate (SFR) (primary outcome).

2. Complicatins of surgery (primary outcome).

3. Change in haematocrit pre and postoperative (secondary outcome).

4. Operative time (secondary outcome).

5. Duration of hospitalization (secondary outcome). .

7-Fluroscpic screening time (FST) (secondary outcome). . 8- Change in haematocrit pre and postoperative (secondary outcome).

Description:

Percutaneous nephrolithotomy (PNL) is an appropriate first-line alternative for the management of kidney stones that are larger than 2 cm in diameter and that do not respond to extracorporeal shock wave lithotripsy (SWL) [1,2].

Percutaneous renal access is the most important step in PNL, and the adequacy of access directly affects the success and complication rates of this procedure.

Among C-arm fluoroscopy, computed tomography (CT), and ultrasonography (US), C-arm fluoroscopy is the most commonly used imaging technique to access the intrarenal collecting system [3-4].

Various fluoroscopy techniques have been described for achieving a good access. One can use fluoroscopy or ultrasonography or a combination of both for reaching the target calyx. Each of it has its advantages and disadvantages, and no consensus exists showing the superiority of one or the other [5].

Triangulation and ''eye of the needle'' (or bull's eye) techniques are two common methods to obtain proper percutaneous renal access under fluoroscopy guidance [6-7].

Multiplanar fluoroscopic imaging is essential in both techniques to make a proper renal puncture.

Biplanar access is based on mediolateral and cephalad-caudal movements of the needle, with the depth of the puncture adjusted based on different fluoroscopic projections, including oblique, vertical, and 30° positions [6, 8].

Most published studies of PCNL have focused on evaluating the effect of patient- and stone-related factors such as success rate, extent of bleeding, complication rate, fluoroscopic Screening times (FSTs), and operative time on outcomes. [9-10]

The imaging modalities used for guidance by urologists or radiologists during percutaneous renal access and renal access procedures have also recently been analyzed and compared in terms of outcomes and complications.[11-12]

These studies, however, have not considered the effect of percutaneous renal access technique on outcome. Although the triangulation and the bull's-eye techniques have been evaluated and compared using a biologic model in a published study [13], no clinical study comparing these techniques has been performed.

The aim of this study is to evaluate the impact of percutaneous renal access technique on outcomes of percutaneous nephrolithotomy in management of renal stones by comparing the Triangulation and ''eye of the needle'' (or bull's eye) and the stone targeted technique .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: April 20, 2023
• Est. primary completion date: April 20, 2023
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• The study will include all adult patients that with renal stones larger than 2 cm in diameter who will attend our endourology outpatient clinic from Jan 2021 to February 2023 and consented to participate in the study.

Exclusion Criteria:

• 1-Patients with urinary system anomalies as horseshoe kidney, ectopic pelvic kid.

2-Patients with skeletal malformations. 3-Bleeding tendency and ongoing anticoagulant therapy. 4-Pregnancy. 5-Patients who refuse to be involved in the trial documentation.

Related Conditions & MeSH terms

• Endourology

Intervention

Procedure:
• per-cutaneous stone extraction
percutaneous nephrolithotripsy for renal stones by different renal access

Locations

Country	Name	City	State
Egypt	NIH	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Ashley FL. Implications of wound healing research. A meeting ground for experimental biology and clinical medicine. Plast Reconstr Surg. 1969 Feb;43(2):190-1. — View Citation

Meshkov SL, Seltzer SE, Finberg HJ. CT detection of intraabdominal disease in patients with lower extremity signs and symptoms. J Comput Assist Tomogr. 1982 Jun;6(3):497-501. — View Citation

Schmahl FW, Betz E, Talke H, Hohorst HJ. [Energy rich phosphates and metabolites of energy metabolism in the cerebral cortex in the cat]. Biochem Z. 1965 Sep 30;342(5):518-31. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stone free rate	outcome of residual stone postoperative	48 hours postoperative
Primary	complication of surgery	fever , urine leakage , stent of ureter , sepsis, other intervention	from day one post-operative to 3 months