Triangulation Bulls Eye and Stone Direct Targeting Pcnl

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Endourology
• Intervention / Treatment: Procedure: per-cutaneous stone extraction

Detailed 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 .

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: mahmoud abdo eldardery; Phone Number: 01008763519; Email: m.eldardery91@gmail.com

Study Locations

• Egypt
  • Assiut, Egypt, 20892
    • NIH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

all patients presented to endourology clinic by renal stone and complianting and fit for surgery.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
group 1; bulls eye localization	Procedure: per-cutaneous stone extraction; percutaneous nephrolithotripsy for renal stones by different renal access
group 2; stone targeted technique renal access	Procedure: per-cutaneous stone extraction; percutaneous nephrolithotripsy for renal stones by different renal access
group 3; triangulation renal access technique	Procedure: per-cutaneous stone extraction; percutaneous nephrolithotripsy for renal stones by different renal access

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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. No abstract available. German.
• 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. No abstract available.
• 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. doi: 10.1097/00004728-198206000-00010.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2021
• Primary Completion (Anticipated): April 20, 2023
• Study Completion (Anticipated): April 20, 2023

Study Registration Dates

• First Submitted: April 12, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 15, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2021
• Last Update Submitted That Met QC Criteria: April 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: new pcnl approch

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No