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NCT Number: NCT06519812

Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi

This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety

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Key information

Conditions

Urinary Calculi Calculi Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Urogenital Diseases Urolithiasis Urologic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Azhar University Hospital (New Damietta)

Damietta, 952567, Egypt

Location status: Recruiting

Location contact

Mohamed shenishan, master

CONTACT

[email protected]

01152370018 ext. 020

About this study

This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety The efficacy will be studied at stone-free rate While efficacy will be studied using DMSA scan pre- and post-procedures in addition to the safety of each procedure with regard to intra- and post-operative complications,.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients are more than 18 and less than 65 years old.
  • Patients with renal staghorn stones based on imaging modalities (stones occupying the renal pelvis and extending into at least 2 major calyces).

Exclusion criteria

  • Patients with renal insufficiency (serum creatinine > 1.6 mg/dl)
  • patients with active urinary tract infection.
  • Patients with congenital renal anomalies.
  • Morbid obesity (BMI > 35 kg/m2).
  • Pregnancy.
  • Bleeding Coagulopathy.
  • Skeletal deformity

Treatment and study plan

Combined Intrarenal Surgery and percutaneous nephrolithotomy

Procedure

A study was conducted to compare endoscopic combined intrarenal surgery and percutaneous nephrolithotomy as modalities of treatment for staghorn stones.

Primary outcomes

  1. stone-free rate

    Time frame: 3 months postoperative

    Stone-free is defined as no residual stones on CT-UT or clinically insignificant residual fragments (CIRF) less than 4 mm in diameter.

    It will be measured twice, first immediately postoperatively, and then again after 3 months of the procedure.

Secondary outcomes

  1. Safety of the procedure

    Time frame: intraoperative, early (in the first day postoperative) and late complications (3 months after the surgery).

    Intra and post-operative complications

Study contacts

Contact information is provided by the study sponsor or research team.

Maher Abdelrehem Mohamed, Master

CONTACT

[email protected]

01026816086 ext. 020

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Efficacy and Safety of Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi, A Prospective Randomized Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Jul 25, 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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