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Multitract Percutaneous Nephrolithotomy(PCNL) in Large Renal Stones. (PCNL)

Primary Purpose

Staghorn Calculi

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

PCNL

About this trial

This is an interventional treatment trial for Staghorn Calculi focused on measuring PCNL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Multitract PCNL patients

Arm Description

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

Outcomes

Primary Outcome Measures

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 )

Secondary Outcome Measures

Postoperative complications

Measuring the postoperative complications rates, classification of the severity of the complications will assess the safety of the procedure.

Operative time

Measurment of the time from start of the operation till fixation of nephrostomy tube

Postoperative pain

Measurment of the postoperative pain score using the Visual analogue scale(VAS) that is divided into mild(1-3), moderate(4-6) and sever(7-10) according to the severity of the pain.

Hospital stay

Postoperative hospital stay of the participants till thier discharge

Full Information

NCT ID

NCT05291702

First Posted

January 30, 2022

Last Updated

March 13, 2022

Sponsor

Assiut University

1. Study Identification

Unique Protocol Identification Number

NCT05291702

Brief Title

Multitract Percutaneous Nephrolithotomy(PCNL) in Large Renal Stones.

Acronym

PCNL

Official Title

Multitract PCNL as One Step for Management of Large Renal Stones

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

April 1, 2022 (Anticipated)

Primary Completion Date

August 1, 2024 (Anticipated)

Study Completion Date

October 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Staghorn Calculi

Keywords

PCNL

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Multitract PCNL patients

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

PCNL

Intervention Description

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

Primary Outcome Measure Information:

Title

Stone free rate

Description

Time Frame

The participants will be followed for one month after the procedure

Secondary Outcome Measure Information:

Title

Postoperative complications

Description

Measuring the postoperative complications rates, classification of the severity of the complications will assess the safety of the procedure.

Time Frame

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

Title

Operative time

Description

Measurment of the time from start of the operation till fixation of nephrostomy tube

Time Frame

Average of three hours

Title

Postoperative pain

Description

Measurment of the postoperative pain score using the Visual analogue scale(VAS) that is divided into mild(1-3), moderate(4-6) and sever(7-10) according to the severity of the pain.

Time Frame

Within 24 hours postoperative and till the patient discharge

Title

Hospital stay

Description

Postoperative hospital stay of the participants till thier discharge

Time Frame

Average of six days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Waleed Mahmoud Abbas, M.Sc

Phone

+2001009377858

Dr_walidws@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Ali Zarzour, MD

Phone

+2001014714142

Dr-mohamedali81@yahoo.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

20811557

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.

Results Reference

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Citation

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

Results Reference

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PubMed Identifier

27238616

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.

Results Reference

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PubMed Identifier

26242465

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.

Results Reference

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Multitract Percutaneous Nephrolithotomy(PCNL) in Large Renal Stones.

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