NCT05291702

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

January 30, 2022

Last Update Submit

March 13, 2022

Conditions

Staghorn Calculi

Keywords

PCNL

Outcome Measures

Primary Outcomes (1)

  • Stone free rate

    Assessment of the instant postoperative stone free rate and after one month from the procedure for all 40 participants using the postoperative non contrast computerized tomography (NCCT )and plain on kidney , ureter, urinary bladder (KUB )

    The participants will be followed for one month after the procedure

Secondary Outcomes (4)

  • Postoperative complications

    From the start of the operation and till one month after the patient discharge.

  • Operative time

    Average of three hours

  • Postoperative pain

    Within 24 hours postoperative and till the patient discharge

  • Hospital stay

    Average of six days

Study Arms (1)

Multitract PCNL patients

OTHER

Assessment of the multitract PCNL procedure in removal of large renal stones using pneumatic or laser lithotripsy.

Procedure: PCNL

Interventions

PCNLPROCEDURE

Percutaneous nephrolithotomy ( Extraction of the renal stones using the nephroscope/ Ureteroscope )

Multitract PCNL patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Patients under 18 years old.
  • Patients with renal anomalies.
  • Patients with only function kidney.
  • Patients with distal ureteric obstruction.
  • Patients with radiolucent stone.
  • Patients with febrile urinary tract infection.
  • Patients with abnormal coagulopathy state.
  • Patients refused to participate in this study.
  • pregnancy.
  • Musculoskeletal deformity.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 20811557BACKGROUND

  • Turk C, Petrik A, Sarica K, et al. Urolithiassis. European Association of Urolgy. Accessed: August 23,2019.

    BACKGROUND

  • 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.

    PMID: 27238616BACKGROUND

  • 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.

    PMID: 26242465BACKGROUND

MeSH Terms

Conditions

Staghorn Calculi

Condition Hierarchy (Ancestors)

Kidney CalculiNephrolithiasisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisUrinary CalculiMale Urogenital DiseasesCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Waleed Mahmoud Abbas, M.Sc

CONTACT

+2001009377858Dr_walidws@yahoo.com

Mohamed Ali Zarzour, MD

CONTACT

+2001014714142Dr-mohamedali81@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

January 30, 2022

First Posted

March 23, 2022

Study Start

April 1, 2022

Primary Completion

August 1, 2024

Study Completion

October 1, 2024

Last Updated

March 23, 2022

Record last verified: 2022-03