Urolithiasis
Conditions
Keywords
PCNL, ureteral stent, nephrostomy tube, tubeless, WISQOL questionnaire scores
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.
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.
Interventions
PROCEDUREnot Indwelling the ureteral stent
Before the end of surgery, the urologist does not Indwell the ureteral stent in the patient's body. The ureteral stent is usually called Double-J Stent.
PROCEDUREIndwelling the ureteral stent
Before the end of surgery, the urologist Indwell the ureteral stent in the patient's body. The ureteral stent is usually called Double-J Stent.
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years old * Renal stones\>2cm, preparing for PCNL * Normal reading comprehension ability
Exclusion criteria
* Patients with preoperative neurogenic bladder, Over Active Bladder (OAB), and lower urinary tract symptoms (LUTS). * Kidney transplantation, isolated kidney, horseshoe kidney, urinary diversion, urinary tract abnormalities. * Stricture of ureter or stones of the affected ureter require treatment * Kidney abscess or uncontrolled urinary tract infection * Internal stent was left in the affected ureter within one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | During surgery | Surgery duration, minutes |
| Hospital stay | 1 week | Duration of hospital stay after surgery, days |
| Complication rate | 1 month after sugery | Complication is defined as any adverse event occurred intraoperatively or ≤1 month postoperatively, including intraoperative bleeding, postoperative pain and so on.The investigator will invaluate perioperative complications by modified Clavien system |
| Visual Analogue Scale(VAS) | 1 day after sugery | The basic method is to use a moving ruler about 10cm long, with 10 scales on one side and 0 and 10 points on both ends, where 0 represents no pain and 10 represents the most unbearable pain. |
| Wisconsin Stone Quality of Life questionnaire (WISQOL) Scores | on the 3rd, 14th, and 1st day after surgery | A total of 28 questions were included in 4 aspects (social, disease, vitality, and emotion), and a questionnaire was recorded and filled out on the 3rd, 14th, and 1st day after surgery through telephone inquiry and evaluation. |
Countries
China
Outcome results
None listed