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NCT Number: NCT06350045

High Supracostal Versus Subcostal Puncture in Adult PCNL

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

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Assiut University Hospital

Asyut, 11751, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PCNL

Combination Product

percutaneous nephrolithotomy

Primary outcomes

  1. Rate of complications

    Time frame: within 3 months post operative

    Clavien -Dindo classification.

  2. Stone free rate

    Time frame: within 3 months post operative

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

Secondary outcomes

  1. duration of Hospital stay.

    Time frame: Postoperativly

    post operative hospital stay

  2. Operative time

    Time frame: intraoperative

    from the puncture until withdrawal of the endoscope at the end of the operation

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Renal Puncture Above the Eleventh Rib (High Supracostal Approach) Versus Subcostal Puncture in Percutaneous Nephrolithotomy for Treatment of Renal Stones in Adults: A Prospective Randomized Trial

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 5, 2024
Registry last updated
Apr 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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