Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2025-12-17 @ 8:39 PM
Study NCT ID:
NCT06249100
Status:
None
Last Update Posted:
2024-10-29 00:00:00
First Post:
2024-01-30 00:00:00
Brief Title:
Flexible Mini Percutaneous Nephrolithotomy Vs Retrograde Intra-renal Surgery
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Flexible Mini Percutaneous Nephrolithotomy Vs Retrograde Intra-renal Surgery for Treatment of Renal Stones: a Randomized Controlled Trial
Status:
None
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None