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

N/ARecruitingNCT06519812

Al-Azhar University100 enrolled

Overview

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

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,.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Urinary Calculi

Interventions

Combined Intrarenal Surgery and percutaneous nephrolithotomyPROCEDURE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Al-Azhar University Hospital (New Damietta)

Damietta, Egypt

RECRUITING

Outcomes

Primary Outcomes

stone-free rate

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.

Time frame: 3 months postoperative

Secondary Outcomes

Safety of the procedure

Intra and post-operative complications

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

Central Contacts

Maher Abdelrehem Mohamed, Master

CONTACT

01026816086 maherabdelrehem2690@gmail.com

Data from ClinicalTrials.gov

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