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

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

Study Overview

• Status: Recruiting
• Conditions: Urinary Calculi
• Intervention / Treatment: Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy

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,.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maher Abdelrehem Mohamed, Master; Phone Number: 020 01026816086; Email: maherabdelrehem2690@gmail.com

Study Locations

• Egypt
  • Damietta, Egypt, 952567
    • Recruiting
    • Al-Azhar University Hospital (New Damietta)
    • Contact: Mohamed shenishan, master; Phone Number: 020 01152370018; Email: ffd3994@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: • Group I (PCNL group); 50 patients will undergo percutaneous nephrolithotomy (PCNL).	Procedure: Combined 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.
Experimental: Group II (ECIRS group); 50 patients will undergo endoscopic combined intrarenal surgery (ECIRS).	Procedure: Combined 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Al-Azhar University
• Investigators: Principal Investigator: Maher Abdelrehem Mohamed, Master, assistant lecturer of urology , Al-Azhar University (Damietta)

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 27, 2024
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): July 25, 2024
• Last Update Submitted That Met QC Criteria: July 20, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Pathological Conditions, Anatomical; Nephrolithiasis; Kidney Calculi; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Calculi; Urolithiasis; Calculi; Staghorn Calculi
• Other Study ID Numbers: Urosurg./MD/2023/0008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No