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The Perioperative Outcomes of Papillary Versus Non-Papillary Access in Percutaneous Nephrolithotomy: Results from a prospective randomized trial

The Perioperative Outcomes of Papillary Versus Non-Papillary Access in Percutaneous Nephrolithotomy: Results from a prospective randomized trial

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
PACTR
Registry ID
PACTR202308603946944
Enrollment
70
Registered
2023-08-01
Start date
2023-07-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urological and Genital Diseases

Interventions

Papillary puncture
Non papillary puncture

Sponsors

Tanta University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: All adult patients with renal stones who are fit for surgical intervention and planned to have PCNL.

Exclusion criteria

Exclusion criteria: • Patients who are unfit for surgery due to chronic debilitating diseases (e.g., severe hepatic cirrhosis), uncorrectable bleeding diathesis or immunodeficiency syndromes. • Patients with solitary kidney or single functioning kidney. • Patients with congenital anatomical variants (horseshoe kidney or ectopic kidney). • Patients with chronic renal impairment of serum creatinine > 2 mg/dL • Patients who refuse surgery. • Pregnant females.

Design outcomes

Primary

MeasureTime frame
The aim of this study is to prospectively compare the perioperative outcomes of the standard papillary and the non-papillary accesses in cases of percutaneous nephrolithotomy in terms of safety, feasibility, and efficacy. The primary outcome is safety of the technique, whichwhich will be evaluated by assessing the perioperative complications’ rate and type including fever, elevation of serum creatinine, hemoglobin drop, blood transfusion, injury to the lungs or bowel or other abdominal organs, persistent nephrocutaneous fistula, infundibular stenosis and death.

Secondary

MeasureTime frame
Feasibility will be assessed by calculating the success rate of obtaining an access and the fluoroscopy time passed till puncture is made.;Efficacy will be measured by recording the one-month stone free rate in each arm and the need for any auxiliary procedures.

Countries

Egypt

Contacts

Public ContactMohamed Elbendary

Professor and Consultant of Urology

mohamed.elnady@med.tanta.edu.eg00201006824248

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026