NCT06350045

Brief Summary

as the supra eleventh puncture PCNL is not well investigated in the literature we will conduct that randomised trial in comparison to the subcostal one

Trial Health

75
On Track

Trial Health Score

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

Enrollment
162

participants targeted

Target at P50-P75 for phase_4

Timeline
22mo left

Started Mar 2024

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress56%
Mar 2024Apr 2028

Study Start

First participant enrolled

March 1, 2024

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 5, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

April 5, 2024

Status Verified

April 1, 2024

Enrollment Period

4.1 years

First QC Date

March 29, 2024

Last Update Submit

April 3, 2024

Conditions

Urolithiasis

Outcome Measures

Primary Outcomes (2)

  • Rate of complications

    Clavien -Dindo classification.

    within 3 months post operative

  • Stone free rate

    the patient being either completely stone-free or there are residual fragments (less than 4 mm).

    within 3 months post operative

Secondary Outcomes (2)

  • duration of Hospital stay.

    Postoperativly

  • Operative time

    intraoperative

Study Arms (2)

subcostal puncture PCNL

EXPERIMENTAL

puncturing the subcostal region to reach the kidney

Combination Product: PCNL

supracostal puncture PCNL

EXPERIMENTAL

puncturing the supra eleventh rib

Combination Product: PCNL

Interventions

PCNLCOMBINATION_PRODUCT

percutaneous nephrolithotomy

subcostal puncture PCNLsupracostal puncture PCNL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old.
  • Patients amenable for PCNL with stone burden between 2 cm - 4 cm (guy score 1-2-3)

You may not qualify if:

  • Ectopic kidney.
  • Single middle calyceal stone.
  • Skeletal anomalies.
  • Bleeding diathesis.
  • Active urinary tract infection.
  • Patient refusing participation.
  • Patients with active pulmonary and pleural disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 11751, Egypt

Location

Related Publications (6)

  • Fernstrom I, Johansson B. Percutaneous pyelolithotomy. A new extraction technique. Scand J Urol Nephrol. 1976;10(3):257-9. doi: 10.1080/21681805.1976.11882084.

    PMID: 1006190BACKGROUND

  • Galvin DJ, Pearle MS. The contemporary management of renal and ureteric calculi. BJU Int. 2006 Dec;98(6):1283-8. doi: 10.1111/j.1464-410X.2006.06514.x. No abstract available.

    PMID: 17125486BACKGROUND

  • He Z, Tang F, Lu Z, He Y, Wei G, Zhong F, Zeng G, Wu W, Yan L, Li Z. Comparison of Supracostal and Infracostal Access For Percutaneous Nephrolithotomy: A Systematic Review and Meta-Analysis. Urol J. 2019 May 5;16(2):107-114. doi: 10.22037/uj.v0i0.4727.

    PMID: 30882159BACKGROUND

  • Sampaio FJ. Renal anatomy. Endourologic considerations. Urol Clin North Am. 2000 Nov;27(4):585-607, vii. doi: 10.1016/s0094-0143(05)70109-9.

    PMID: 11098758BACKGROUND

  • Sinha M, Krishnappa P, Subudhi SK, Krishnamoorthy V. Supracostal percutaneous nephrolithotomy: A prospective comparative study. Indian J Urol. 2016 Jan-Mar;32(1):45-9. doi: 10.4103/0970-1591.173121.

    PMID: 26941494BACKGROUND

  • Mousavi-Bahar SH, Mehrabi S, Moslemi MK. The safety and efficacy of PCNL with supracostal approach in the treatment of renal stones. Int Urol Nephrol. 2011 Dec;43(4):983-7. doi: 10.1007/s11255-011-9916-y. Epub 2011 Mar 11.

    PMID: 21394440BACKGROUND

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • ayman assem, dr

    Assiut University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
closed envelop
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 29, 2024

First Posted

April 5, 2024

Study Start

March 1, 2024

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

April 1, 2028

Last Updated

April 5, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)