Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06455618
Status:
COMPLETED
Last Update Posted:
2024-06-12
First Post:
2024-06-07
Brief Title:
The Feasibility Safety and Efficacy of Not Indwelling of Ureteral Stents in Percutaneous Nephrolithotomy
Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Organization:
The First Affiliated Hospital of Guangzhou Medical University
Study Overview
Official Title:
The Feasibility Safety and Efficacy of Not Indwelling of Ureteral Stents in Percutaneous Nephrolithotomy A Randomized Controlled Trial
Status:
COMPLETED
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:
Percutaneous nephrolithotomy PCNL is currently the preferred treatment for upper urinary tract stones larger than 2cm In the standard PCNL procedure a nephrostomy tube and a ureteral stent are often placed before the end of surgery Recently PCNL without indwelling nephrostomy tube but with indwelling ureteral stent also called tubeless PCNL or PCNL without indwelling nephrostomy tube and ureteral stent also called totally tubeless PCNL has been put into practice Compared with the standard PCNL tubeless or totally tubeless PCNL can effectively reduce postoperative pain and shorten hospital stay while the incidence of complications does not significantly increase
Is it possible not to leave a ureteral stent but leave a nephrostomy tube also called stent-less PCNL after PCNL In theory the nephrostomy tube can have certain effect such as decreasing the risk of post-operative bleeding On the other hand not indwelling a ureteral stent can bring benefits to patients Recently there is limited research on not indwelling ureteral stent after PCNL and its safety and feasibility require clinical validation
In summary investigators conducted a prospective randomized controlled trial to explore the safety and feasibility of not indwelling ureteral stent after PCNL
Is it possible not to leave a ureteral stent but leave a nephrostomy tube also called stent-less PCNL after PCNL In theory the nephrostomy tube can have certain effect such as decreasing the risk of post-operative bleeding On the other hand not indwelling a ureteral stent can bring benefits to patients Recently there is limited research on not indwelling ureteral stent after PCNL and its safety and feasibility require clinical validation
In summary investigators conducted a prospective randomized controlled trial to explore the safety and feasibility of not indwelling ureteral stent after PCNL
Detailed Description:
Percutaneous nephrolithotomy PCNL is currently the preferred treatment for upper urinary tract stones larger than 2cm In the standard PCNL procedure a nephrostomy tube and a ureteral stent are often placed before the end of surgery to ensure urine drainage promote fistula healing and reduce the occurrence of kidney stones entering the ureter With the improvement of surgical techniques PCNL without indwelling nephrostomy tube but with indwelling ureteral stent also called tubeless PCNL or PCNL without indwelling nephrostomy tube and ureteral stent also called totally tubeless PCNL has been put into practice Compared with the standard PCNL tubeless or totally tubeless PCNL can effectively reduce postoperative pain and shorten hospital stay while the incidence of complications does not significantly increase
Is it possible not to leave a ureteral stent but leave a nephrostomy tube also called stent-less PCNL after PCNL This clever method combined two advantages In theory the nephrostomy tube can have certain effect such as decreasing the risk of post-operative bleeding and avoiding the occurrence of emergency events related to ureteral stones On the other hand not indwelling a ureteral stent can bring benefits to patients Recently there is limited research on not indwelling ureteral stent after PCNL and its safety and feasibility require clinical validation
On the other hand the Wisconsin Stone Quality of Life WISQOL as a specific quality of life scoring system for stone patients has been widely promoted and applied in many countries around the world Investigators have recently translated this foreign version of the scoring system into Chinese in order to help serve patients with urinary tract stones in China
In summary investigators conducted a single center prospective randomized controlled trial RCT to compare and analyze the complications of not indwelling ureteral stent after PCNL WISQOL questionnaire scores and explore the safety and feasibility of not indwelling ureteral stent after PCNL
Is it possible not to leave a ureteral stent but leave a nephrostomy tube also called stent-less PCNL after PCNL This clever method combined two advantages In theory the nephrostomy tube can have certain effect such as decreasing the risk of post-operative bleeding and avoiding the occurrence of emergency events related to ureteral stones On the other hand not indwelling a ureteral stent can bring benefits to patients Recently there is limited research on not indwelling ureteral stent after PCNL and its safety and feasibility require clinical validation
On the other hand the Wisconsin Stone Quality of Life WISQOL as a specific quality of life scoring system for stone patients has been widely promoted and applied in many countries around the world Investigators have recently translated this foreign version of the scoring system into Chinese in order to help serve patients with urinary tract stones in China
In summary investigators conducted a single center prospective randomized controlled trial RCT to compare and analyze the complications of not indwelling ureteral stent after PCNL WISQOL questionnaire scores and explore the safety and feasibility of not indwelling ureteral stent after PCNL
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