Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462573
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
Extra-Corporeal Shock Wave Lithotripsy for Renal and Upper Ureteral Stones in Adults Under Locally Infiltrate d Anaesthetics a Clinical Randomized Controlled Study
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Extra-Corporeal Shock Wave Lithotripsy for Renal and Upper Ureteral Stones in Adults Under Locally Infiltrate d Anaesthetics a Clinical Randomized Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
There are many treatment modalities available for managing renal and upper ureteric stones They range from completely non-invasive outpatient procedures to invasive procedures requiring hospital admission and increased risks of complications Extracorporeal shockwave lithotripsy ESWL is a truly non-invasive procedure as opposed to other surgical treatments used such as retrograde intrarenal surgery and percutaneous nephrolithotomy 1
The choice between shockwave lithotripsy SWL and other treatment modalities depends on several factors including stone site stone burden stone CT density etc Another compounding factor in choosing the treatment modality is patient preference and expectation 1
Extracorporeal Shock Wave Lithotripsy is one of the treatment options for patients with renal and ureteral calculi Even though the procedure is less invasive compared to others Pain caused by the procedure is a major concern Several studies recommended the use of either local or systemic analgesia with varying results 2
As a truly non-invasive treatment option ESWL has been widely used for treating renal as well as ureteric stones with satisfactory efficacy and minimal morbidity However the pain caused by ESWL is a major limitation of its efficacy in addition to the associated patient dissatisfaction and negative experience that may result in the patient refraining from further sessions
The relationship between pain and ESWL efficacy can be explained by multiple facts firstly the pain leads to inability to increase the energy delivered by the shockwaves to optimum levels secondly the pain usually leads to significant movement of the patient as well as excessive respiratory movements both of which move the stone away from the focus of shockwaves lastly the pain may be severe that the session is discontinued before delivery of effective number of shockwaves
The choice between shockwave lithotripsy SWL and other treatment modalities depends on several factors including stone site stone burden stone CT density etc Another compounding factor in choosing the treatment modality is patient preference and expectation 1
Extracorporeal Shock Wave Lithotripsy is one of the treatment options for patients with renal and ureteral calculi Even though the procedure is less invasive compared to others Pain caused by the procedure is a major concern Several studies recommended the use of either local or systemic analgesia with varying results 2
As a truly non-invasive treatment option ESWL has been widely used for treating renal as well as ureteric stones with satisfactory efficacy and minimal morbidity However the pain caused by ESWL is a major limitation of its efficacy in addition to the associated patient dissatisfaction and negative experience that may result in the patient refraining from further sessions
The relationship between pain and ESWL efficacy can be explained by multiple facts firstly the pain leads to inability to increase the energy delivered by the shockwaves to optimum levels secondly the pain usually leads to significant movement of the patient as well as excessive respiratory movements both of which move the stone away from the focus of shockwaves lastly the pain may be severe that the session is discontinued before delivery of effective number of shockwaves
Detailed Description:
There are many treatment modalities available for managing renal and upper ureteric stones They range from completely non-invasive outpatient procedures to invasive procedures requiring hospital admission and increased risks of complications Extracorporeal shockwave lithotripsy ESWL is a truly non-invasive procedure as opposed to other surgical treatments used such as retrograde intrarenal surgery and percutaneous nephrolithotomy 1
The choice between shockwave lithotripsy SWL and other treatment modalities depends on several factors including stone site stone burden stone CT density etc Another compounding factor in choosing the treatment modality is patient preference and expectation 1
Extracorporeal Shock Wave Lithotripsy is one of the treatment options for patients with renal and ureteral calculi Even though the procedure is less invasive compared to others Pain caused by the procedure is a major concern Several studies recommended the use of either local or systemic analgesia with varying results 2
As a truly non-invasive treatment option ESWL has been widely used for treating renal as well as ureteric stones with satisfactory efficacy and minimal morbidity However the pain caused by ESWL is a major limitation of its efficacy in addition to the associated patient dissatisfaction and negative experience that may result in the patient refraining from further sessions
The relationship between pain and ESWL efficacy can be explained by multiple facts firstly the pain leads to inability to increase the energy delivered by the shockwaves to optimum levels secondly the pain usually leads to significant movement of the patient as well as excessive respiratory movements both of which move the stone away from the focus of shockwaves lastly the pain may be severe that the session is discontinued before delivery of effective number of shockwaves
The choice between shockwave lithotripsy SWL and other treatment modalities depends on several factors including stone site stone burden stone CT density etc Another compounding factor in choosing the treatment modality is patient preference and expectation 1
Extracorporeal Shock Wave Lithotripsy is one of the treatment options for patients with renal and ureteral calculi Even though the procedure is less invasive compared to others Pain caused by the procedure is a major concern Several studies recommended the use of either local or systemic analgesia with varying results 2
As a truly non-invasive treatment option ESWL has been widely used for treating renal as well as ureteric stones with satisfactory efficacy and minimal morbidity However the pain caused by ESWL is a major limitation of its efficacy in addition to the associated patient dissatisfaction and negative experience that may result in the patient refraining from further sessions
The relationship between pain and ESWL efficacy can be explained by multiple facts firstly the pain leads to inability to increase the energy delivered by the shockwaves to optimum levels secondly the pain usually leads to significant movement of the patient as well as excessive respiratory movements both of which move the stone away from the focus of shockwaves lastly the pain may be severe that the session is discontinued before delivery of effective number of shockwaves
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