MedDataX Logo

Management of Medium Sized Renal Stones

NCT ID: NCT06720311

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Urinary stone disease is a common urological condition that affects millions of people worldwide, often leading to significant morbidity and healthcare costs. Medium-sized renal stones, typically defined as stones measuring 1 to 2 cm in diameter, pose a particular challenge in management. These stones are large enough to potentially cause significant obstruction and symptoms, yet their size and location make selecting an optimal treatment modality crucial for achieving favorable outcomes with minimal complications.

Historically, open surgery was the primary intervention for large or complex stones. However, the advent of minimally invasive techniques has revolutionized stone management, allowing for more effective and patient-friendly approaches. Among these, Super-mini percutaneous nephrolithotomy (SMP), flexible uretero-renoscopy (F-URS), and shock wave lithotripsy (SWL) have emerged as minimally invasive modalities for managing medium-sized renal stones.

This study aims to evaluate the outcomes; safety, efficacy, and complications associated with SMP versus F-URS Versus SWL in the management of reanl stones 10-20 mm in diameter.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. SWL All cases will be treated as day care procedures, under analgesia without any anesthesia. Dornier MedTech (Compact Delta II), an electromagnetic shock wave lithotripter will be used. Patients will be treated in supine position and the calculus will be localized by using X-ray or Ultrasound. All sessions will be performed by a single technician under the supervision of a urology consultant. Shock waves will be delivered at the rate of 60-80 per minute with a maximum of 2500 shocks per session of treatment. Session will be started with low energy waves and gradually increased according to patient tolerability. A maximum of 2 sessions spaced two weeks apart. All patients will be advised to drink lots of fluids and maintain active lifestyle and skipping exercises if possible. Prior to every sitting an X-ray KUB will be obtained to see for the state of clearance of stone.
2. Tubeless Super mini-PCNL (SMP) Modified technique will be performed in prone position using 14 Fr Amplatz sheath with the use of Karl Stroz semi rigid ureteroscope, Holmium Laser. Lithotripsy will be achieved by means of Holmium laser fiber 365 um.

Ureteric catheter will be removed after 24 hours unless there is indications for JJ stent insertion ( eg. Only functioning kidney, perforation, etc)
3. F-URS A sensor guide wire was placed into the renal pelvis via rigid ureteroscope. A 11-13 Fr access sheath will be placed into the ureter, if possible. After ureteral access was obtained, a 8 Fr flexible ureteroscope will be used for the stone treatment. The stones disintegration by holmium laser fibers. At the end of the procedure, a ureteral stent (JJ stent or Ureteric catheter) will be inserted

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Stones

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Medium sized renal stones

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Modified Tubeless Super-Mini Percutaneous Nephrolithotomy

Group Type ACTIVE_COMPARATOR

Modified Tubeless Super-Mini Percutaneous Nephrolithotomy

Intervention Type PROCEDURE

Modified Tubeless Super-Mini Percutaneous Nephrolithotomy

Flexible Ureterorenoscopy

Group Type ACTIVE_COMPARATOR

Flexible Ureterorenoscopy

Intervention Type PROCEDURE

Flexible Ureterorenoscopy

Shockwave Lithotripsy

Group Type ACTIVE_COMPARATOR

Shockwave Lithotripsy

Intervention Type PROCEDURE

Shockwave Lithotripsy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Modified Tubeless Super-Mini Percutaneous Nephrolithotomy

Modified Tubeless Super-Mini Percutaneous Nephrolithotomy

Intervention Type PROCEDURE

Flexible Ureterorenoscopy

Flexible Ureterorenoscopy

Intervention Type PROCEDURE

Shockwave Lithotripsy

Shockwave Lithotripsy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients (≥ 18 years old)
* Single renal stones 10-20 mm in longest dimension

Exclusion Criteria

* Previous upper urinary tract exploration in ipsilateral side.
* Patients with JJ stent in ipsilateral side.
* Absolute contraindications to SWL
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ahmed Hamdan Gameel

Urologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ahmed Hamdan

Role: CONTACT

Phone: +201020959949

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AssiutU AGameel

Identifier Type: -

Identifier Source: org_study_id