Clinical trial NCT05291702: Multitract Percutaneous Nephrolithotomy(PCNL) in Large Renal Stones.
Official title: Multitract PCNL as One Step for Management of Large Renal Stones
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Staghorn Calculi
Keywords: PCNL
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigator aimed to analyze the clinical efficacy and safety of multiple tracts PCNL as one step therapy to treat the staghorn stones or multiple calyceal calculi which are inaccessible by single tract

Detailed description: Staghorn calculi are branched stones either partial or complete occupying the pelvis and one or more of the renal caliceal system that is detected by non contrast computrized tomography (NCCT) and plain on kidney, ureter, urinary bladder (KUB). An untreated staghorn calculus over time can damage the kidney and deteriorate its function and /or cause life threatening sepsis.

Total stone clearance is an important goal to eradicate any infective focus, relieve obstruction and preserve the kidney function.

Based on American Urological Association (AUA) guideline, PCNL is the most effective, safest and minimally invasive treatment option compared to open surgery

Eligibility criteria: Inclusion Criteria:

1. Adult patients more than 18 years old.
2. Patients with staghorn stone (partial, complete).
3. Patients with multiple calyceal calculi which are inaccessible by single tract.

Exclusion Criteria:

1. Patients under 18 years old.
2. Patients with renal anomalies.
3. Patients with only function kidney.
4. Patients with distal ureteric obstruction.
5. Patients with radiolucent stone.
6. Patients with febrile urinary tract infection.
7. Patients with abnormal coagulopathy state.
8. Patients refused to participate in this study.
9. pregnancy.
10. Musculoskeletal deformity.

Primary outcomes:
measure: Stone free rate
timeFrame: The participants will be followed for one month after the procedure
Secondary outcomes:
measure: Postoperative complications
timeFrame: From the start of the operation and till one month after the patient discharge.
measure: Operative time
timeFrame: Average of three hours
measure: Postoperative pain
timeFrame: Within 24 hours postoperative and till the patient discharge
measure: Hospital stay
timeFrame: Average of six days
Other outcomes:
Locations:
Study officials:
References:
citation: Romero V, Akpinar H, Assimos DG. Kidney stones: a global picture of prevalence, incidence, and associated risk factors. Rev Urol. 2010 Spring;12(2-3):e86-96.
citation: Turk C, Petrik A, Sarica K, et al. Urolithiassis. European Association of Urolgy. Accessed: August 23,2019.
citation: Assimos D, Krambeck A, Miller NL, Monga M, Murad MH, Nelson CP, Pace KT, Pais VM Jr, Pearle MS, Preminger GM, Razvi H, Shah O, Matlaga BR. Surgical Management of Stones: American Urological Association/Endourological Society Guideline, PART I. J Urol. 2016 Oct;196(4):1153-60. doi: 10.1016/j.juro.2016.05.090. Epub 2016 May 27.
citation: Zhu W, Liu Y, Liu L, Lei M, Yuan J, Wan SP, Zeng G. Minimally invasive versus standard percutaneous nephrolithotomy: a meta-analysis. Urolithiasis. 2015 Nov;43(6):563-70. doi: 10.1007/s00240-015-0808-y. Epub 2015 Aug 5.