High Supracostal Versus Subcostal Puncture in Adult PCNL

NCT ID: NCT06350045

Last Updated: 2024-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2028-04-01

Brief Summary

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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

Detailed Description

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The use of percutaneous nephrolithotomy (PCNL) was first reported by Fernström and Johansson in 1976. Percutaneous nephrolithotomy (PCNL) is the accepted treatment for staghorn stones, large renal stones, and some upper ureteric stones. Achieving suitable access to the appropriate calyx is one of the most important steps during the PCNL procedure. Effective puncture is key for the success of PCNL. An ideal percutaneous nephrolithotomy (PCNL) puncture has been described as one that provides the shortest and straightest access to all calculi, avoids major vessels, bowel and lung, lies along the axis of the calyx and causes minimal parenchymal damage.

Many studies have reported that supracostal access for PCNL is advantageous over infracostal access. By creating a straight path along the kidney's long axis, the upper-pole method guarantees access to the majority of the collecting system and makes it simpler to manipulate the rigid nephroscope and other rigid devices. Therefore, supracostal puncture is perhaps the greatest method for gaining access to the upper pole calyx, where staghorn and big, complicated renal stones are most likely to be located. Although pneumothorax, hydrothorax, and lung damage (1-10%) can result after a supracostal puncture, this injury can now be handled with minimal morbidity thanks to advances in surgical technique and understanding of pleural and diaphragmatic architecture.

Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
closed envelop

Study Groups

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subcostal puncture PCNL

puncturing the subcostal region to reach the kidney

Group Type EXPERIMENTAL

PCNL

Intervention Type COMBINATION_PRODUCT

percutaneous nephrolithotomy

supracostal puncture PCNL

puncturing the supra eleventh rib

Group Type EXPERIMENTAL

PCNL

Intervention Type COMBINATION_PRODUCT

percutaneous nephrolithotomy

Interventions

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PCNL

percutaneous nephrolithotomy

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Ahmed Gaber

Principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ayman assem, dr

Role: STUDY_CHAIR

Assiut University

Locations

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Assiut University Hospital

Asyut, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 1006190 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17125486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30882159 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11098758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26941494 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21394440 (View on PubMed)

Other Identifiers

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supra 11th puncture PCNL

Identifier Type: -

Identifier Source: org_study_id

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