Novel Technique for PCNL Access

Sponsor

Benha University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05640219

Collaborator

mohamed abdelzaher (Other)

Enrollment

1.7

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Benha modification for renal track creation in percutaneous nephrolithotomy (PCNL) Our modification aims to decrease the complications of PCNL in large stones

Condition or Disease	Intervention/Treatment	Phase
PCNL	Device: laparoscopic trocar 12mm	N/A

Detailed Description

Introduction : PCNL occupies the best stone management modality till now in large stones with promissing impacts as regard to morbidity and hospital stay time. (1,2,3) Many reported complications due to PCNL either intra or postoperative especially in large stones up to 83% including bleedng and extravasation .(4) Single step dilatation during PCNL track forminghave many advantages over sequential dilatation as it ismore economic with less blood loss and less radiation exposure, so it is advantageous than conventional Alken or teflon sequential dilators also it is more economic than balloon dilators. (5,6,7,8) To decrease the incidence bleeding, the manipulation should be limited and transpapillary puncture should be kept. (9) Extravasation remains one of the most serious complication during PCNL as vigorousabsorption of the irrigant fluid may cause electrolyte disbalance that may lead to cardiac complications (overload) or brain edema.. (10) Objective : Our modification aims to decrease the complications of PCNL in large stones.

Patients and methods : Our modification will be performed in our department in Benha univerisity hospital with a written consent on 10 patients with partial staghorn stone more than 4 cm occupying the renal pelvis and the lower calyx +/_ the upper calyx in patints 18 years old or more. Also, patients with uncorrected bleeding disorders, moderate or high risk cardiac patients , active urinary tract infection , skletal deformities or patients with complete staghorn stone will be excluded.

Preoperative assesment:

full history and clinical examination
full laboratory investigation including heamoglobin (Hb) and serum creatinine (Scr)
radiological investigation as pelviabdomenal ultrasound , plain X ray (KUB) and coputerized tomography (CT)

Intraoperative assesment:

Under general anaesthesia, after ureteric catheter insertion and using fluoroscopic guidancein prone position introducing a superstiff guide wire targeting the posterior lower calyx transpapillary by puncture needle application then by a straight long artery beside the puncture needle advancing it till penetrating the fascia then open it in two different perpendicular planes to creat a wide tract permitting single step dilatation over the stiff guide wire then safety guide wire will be inserted .Using a long laparoscopic trocar 12mm (36 french) with central hole from its tip till its handle with transparent sheath also a side scrow included to adjust the irrigation fluid outflow and permitting using a suction system if stone disintegration performed while saline irrigation through the ureteric catheter was acting.

The superstiff wire will pass through the tip hole of the trocar ,then under C arm imaging the trocar directed to the targeted calx transpapillary not reaching the calyceal neck then nephroscopy and pneumatic lithotripsy used and then large fragments will be extracted and may reaches 1.5 to 2 cm.

Till the procedure end ,intraoperative time and the need for blood transfusion will be recorded.

Nephrotomy tube 28 f will be fixed in all cases.

Postoperative assessment:

Postoperative Hb , Scr KUB and CT if needed in the next morning will be performed, Also hospital stay and postoperative complications will be registered as fever , heamaturia and leakage from the nephrostoy tube site after its removal.

Keywords: single step dilatation, complications, partial staghorn stones, percutaneous nephrolithotomy Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

References :

Geraghty J.P. and Somani B.K. (2017): Worldwide Trends of urinary stone disease treatment over the last two decades: a systematic review. J Endourol.; 31(6):547-556.
Jones P., Elmussareh M., Aboumarzouk O. M., Mucksavage P. and Somani B. K.(2018): Role of Minimally Invasive (Micro and Ultra-mini) PCNL for Adult Urinary Stone Disease in the Modern Era: Evidence from a Systematic Review. Current Urology Reports 19: 27.
Turk C, Petrik A, Sarica K, Seitz C, Skolarikos A, Straub M,Drake T ,Donaldson JF ,and Rubayel L (2019): EAU guideline on urolithiasis. [Accessed 2 July 2019]
Michel MS, Trojan L,and Rassweiler JJ(2007): Complications in Percutaneous Nephrolithotomy in European urology.; 51(4)899-906.
El-Shazly M, Salem S, Allam A, Hathout B. Balloon dilator versus telescopic metal dilators for tract dilatation during percutaneous nephrolithotomy for staghorn stones and calyceal stones. Arab J Urol 2015;13:80-3.
Nour HH, Kamal AM, Zayed AS, Refaat H, Badawy MH, El-Leithy TR, et al. Single-step renal dilatation in percutaneous nephrolithotomy: A prospective randomised study. Arab J Urol 2014;12:219-22.
Suelozgen T, Isoglu CS, Turk H, Yoldas M, Karabicak M, Ergani B, et al. Can we use single-step dilation as a safe alternative dilation method in percutaneous nephrolithotomy? Urology 2017;99:38-41.
Desai MR, Sharma R, Mishra S, Sabnis RB, Stief C, Bader M, et al. Single-step percutaneous nephrolithotomy (microperc): The initial clinical report. J Urol 2011;186:140-5.
Akman T, Binbay M, Sari E, Yuruk E, Tepeler A, Akcay M,Muslumanoglu AY and Tefekli.A (2011). Factors affecting bleeding during percutaneousnephrolithotomy: single surgeon experience. J Endourol; 25:327e33
Taylor E, Miller J, Chi T,and Stoller ML (2012). Complications associated with percutaneous nephrolithotomy. Transl Androl Urol ; 1:223-228.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Benha Modification for Renal Track Creation in Percutaneous Nephrolithotomy (PCNL), How and Why?

Anticipated Study Start Date :

Jan 25, 2023

Anticipated Primary Completion Date :

Mar 7, 2023

Anticipated Study Completion Date :

Mar 17, 2023

Outcome Measures

Primary Outcome Measures

decrease the intraoperative complication [intraoperative]
assessing the operative time in minutes
blood loss in the operative theatre [intraoperative]
pre and postoperative haemoglobine in gram/dl

Secondary Outcome Measures

early postoperative impact and incidence of complication [withen 10 days postoperative]
fever, heamaturia and leakage from the nephrostomy site

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

patients with partial staghorn stone more than 4 cm occupying the renal pelvis and the lower calyx +/_ the upper calyx in patints 18 years old or more

Exclusion Criteria:

patients with uncorrected bleeding disorders, moderate or high risk cardiac patients , active urinary tract infection , skletal deformities or patients with complete staghorn

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Benha University
mohamed abdelzaher

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

mohamed abdelrahman alhefnawy, assistant professor, Benha University

ClinicalTrials.gov Identifier:

NCT05640219

Other Study ID Numbers:

PCNL track

First Posted:

Dec 7, 2022

Last Update Posted:

Jan 25, 2023

Last Verified:

Dec 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by mohamed abdelrahman alhefnawy, assistant professor, Benha University

complications, partial staghorn stones, PCNL

Study Results

No Results Posted as of Jan 25, 2023