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Completed

NCT Number: NCT06249100

Flexible Mini Percutaneous Nephrolithotomy Vs Retrograde Intra-renal Surgery

The use of flexible ureteroscopy and minimally-invasive percutaneous techniques, which utilize smaller tract sizes, has been established as a way to decrease the invasiveness of procedures and improve patient outcomes compared to conventional percutaneous nephrolithotomy (PCNL) and flexible mini-PCNL has emerged as a novel technique previously first as an auxiliary procedure and then as a standalone technique. This study aims to assess the feasibility and effectiveness of flexible nephoscopy in improving stone clearance compared to standard retrograde intrarenal surgery using a flexible ureteroscope.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ain Shams University Hospitals

Cairo, Cairo Governorate, 11361, Egypt

About this study

Urinary stones are one of the most common rising health concerns around the world. Urolithiasis is particularly common in high-income countries, with more than 10% of people suffering from it. Renal stones often manifest as colicky loin pain, often known as renal colic.

Percutaneous nephrolithotomy (PCNL) is highly recommended by international guidelines as the primary treatment for renal stones larger than 20 mm. However, for stones ranging from 10 to 20 mm in size, treatment options may include shock wave lithotripsy (SWL), PCNL, or retrograde intrarenal surgery (RIRS).

Significant advancements have been achieved in surgical techniques recently, leading to the emergence of minimally invasive percutaneous nephrolithotomy (mini-PCNL) as a viable and effective treatment option for the removal of large renal and proximal ureteral stones.

In recent years, there has been a consistent reduction in the size of endoscopic instruments. The primary objective of these tools is to minimize the amount of blood lost during surgery, lower the occurrence of complications both during and after the operation, and ultimately reduce the length of hospital stays.

Despite the use of a smaller nephroscope, the rigidity of the mini-nephroscope poses a limitation in maneuvering into renal calyces at acute angles. This limitation may necessitate the creation of additional tracts, leading to an increase in morbidity. To tackle this challenge, a new technique flexible mini-nephroscope has been developed. This innovative instrument allows for access to all regions of the pelvi-caliceal system through a single access tract.

Retrograde Intrarenal Surgery (RIRS) is a prominent approach utilized to eliminate kidney stone disease. In contrast to PCNL, RIRS offers the benefit of utilizing a natural orifice, thereby eliminating the need for an additional pathway for lithotripsy. Consequently, this treatment option ensures enhanced safety and facilitates a more favorable postoperative recovery process.

RIRS has some significant limitations that make it challenging to retrieve a large number of fragments after the lithotripsy of large stones. Additionally, there is a complicated balance between irrigation and intrarenal pressure that must be maintained. While continuous rinsing of renal cavities is necessary to improve visibility, an imbalanced fluid evacuation can lead to a rise in pressure within the collecting system. Due to these limitations, large stones cannot be treated with a single RIRS procedure, and multiple sessions may be required. This exposes the patient to repeated anesthesia and the risk of ureteral damage and stenosis, making it important to limit operative time and prevent complications.

This study aims to compare the clinical outcome in the form of safety and efficacy between flexible mini-nephroscopy in minimally-invasive PCNL and retrograde intra-renal surgery in patients with symptomatic renal stones.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients above the age of 16 years of either sex presented to the Urology clinic in our university hospitals
  • kidney stones with a size not exceeding 3.0 cm (estimated by CTUT as the greatest dimension or the summation of the greatest dimensions in case of more than one stone detected)

Exclusion criteria

  • Patients with lumber hernia on the same site of the surgery
  • Patients with a stone burden exceeding 3cm
  • Patients with renal anomalies preventing access
  • Patients with coagulopathies/bleeding tendency
  • Patients with untreated or active UTI

Treatment and study plan

flexible mini percutaneous nephrolithotomy

Procedure

In Group A (flexible mini-PCNL cases), a puncture will be done under fluoroscopic guidance medial to the posterior axillary line using an 18-gauge puncture needle. The puncture will be directed horizontally or with a slight upward inclination towards the lower or middle calyx. After a successful puncture, a 0.035 Fr Super Stiff guidewire will be inserted. Tract dilatation with amplatz dilator followed by access sheath insertion. Stone disintegration will be done with the flexible mini-nephroscopy (WiScope Digital Endoscope System by OTU Medical, California, USA) which has a shaft length of 38 cm, distal tip diameter is 15.3 F tapering to 10 F, working channel inner diameter is 6.6 F, and the angle of deflection of the distal tip is 210 degrees.

Retrograde Intrarenal Surgery

Procedure

n Group B, Flexible ureteroscopy will be used with a ureteral access sheath and laser fragmentation of renal stones will be done

Primary outcomes

  1. stone-free rate

    Time frame: 1 month postoperative

    patients will be considered stone free, if the stone residual in the follow up is less than 4mm

Secondary outcomes

  1. Operative time

    Time frame: 24 hour postoperative

    time from starting the procedure with the cystoscopy till termination with catheter insertion. intraoperative finding in minutes

  2. Hospital Stay

    Time frame: 1 month postoperative

    duration of hospital stay since admission on the day of the procedure till discharge

  3. Cost analysis

    Time frame: 1 month postoperative

    evaluation of the procedure cost, the additional cost of hospital stay, complication and auxiliary procedure needed for stone residual.

  4. infection rate

    Time frame: up to 1 month postoperative

    evaluation of postoperative urinary tract infection

  5. Hemoglobin drop

    Time frame: 1 day postoperative

    evaluation of hemoglobin drop in the procedure by CBC

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Flexible Mini Percutaneous Nephrolithotomy Vs Retrograde Intra-renal Surgery for Treatment of Renal Stones: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 8, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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