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

NCT06519812 | Recruiting

• 1 other identifier: Urosurg./MD/2023/0008
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Calculi

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of the procedure

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

Study Arms (2)

• Group I (PCNL group)

EXPERIMENTAL

50 patients will undergo percutaneous nephrolithotomy (PCNL).

Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy

Group II (ECIRS group)

EXPERIMENTAL

50 patients will undergo endoscopic combined intrarenal surgery (ECIRS).

Procedure: Combined Intrarenal Surgery and percutaneous nephrolithotomy

Interventions

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.

Group II (ECIRS group); • Group I (PCNL group)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar University Hospital (New Damietta)

Damietta, 952567, Egypt

RECRUITING

MeSH Terms

Conditions

Urinary Calculi

Interventions

Nephrolithotomy, Percutaneous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Laparoscopy; Endoscopy; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Maher Abdelrehem Mohamed, Master

  assistant lecturer of urology , Al-Azhar University (Damietta)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maher Abdelrehem Mohamed, Master

CONTACT

01026816086; maherabdelrehem2690@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Urology Faculty of Medicine, Al-Azhar University (Damietta)

Study Record Dates

• First Submitted: June 27, 2024
• First Posted: July 25, 2024
• Study Start: July 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: June 30, 2025
• Last Updated: July 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)