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

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06519812

Enrollment

100

Registered

2024-07-25

Start date

2023-07-01

Completion date

2025-06-30

Last updated

2024-07-25

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

Conditions

Urinary Calculi

Brief summary

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

Detailed description

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,.

Interventions

PROCEDURECombined Intrarenal Surgery and percutaneous nephrolithotomy

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
stone-free rate	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

Measure	Time frame	Description
Safety of the procedure	intraoperative, early (in the first day postoperative) and late complications (3 months after the surgery).	Intra and post-operative complications

Countries

Egypt

Contacts

Primary ContactMaher Abdelrehem Mohamed, Master

maherabdelrehem2690@gmail.com01026816086

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026