Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05640219 |
| Other study ID # |
PCNL track |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 25, 2023 |
| Est. completion date |
March 17, 2023 |
Study information
| Verified date |
December 2022 |
| Source |
Benha University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Benha modification for renal track creation in percutaneous nephrolithotomy (PCNL) Our
modification aims to decrease the complications of PCNL in large stones
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 :
1. 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.
2. 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.
3. 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]
4. Michel MS, Trojan L,and Rassweiler JJ(2007): Complications in Percutaneous
Nephrolithotomy in European urology.; 51(4)899-906.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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
10. Taylor E, Miller J, Chi T,and Stoller ML (2012). Complications associated with
percutaneous nephrolithotomy. Transl Androl Urol ; 1:223-228.
