RecruitingACTRN12618000737235

Early removal of the plastic tube placed in ureter after kidney transplantation

Does early removal of ureteric stent simultaneously with indwelling urethral catheter post kidney transplantation reduce the infection and healthcare costs?

Sponsor

Bulang He

Enrollment

80 participants

Start Date

Jan 3, 2019

Study Type

Interventional

Conditions

On the waiting list for kidney transplantation

Summary

Kidney transplantation is a definitive treatment for patients with end stage kidney disease, which extend the patient life expectancy and improve quality of life. During the surgery of kidney transplantation, placement of a ureteric stent at ureter-bladder anastomosis has been confirmed beneficial from systematic literature review and meta-analysis as it reduces the urological complications of urine leakage and ureteric stenosis. On the other hand, placement of a ureteric stent is associated with stent-related complications such as urinary tract infection, BK virus infection, stent irritation symptoms, haemoturia, stent encrustation and rarely “forgotten stent”. In addition, it will require a procedure of cystoscopy under hospital admission to remove the ureteric stent under local anaesthesia or general anaesthesia. It is unknown how long period should a ureteric stent be best kept in situ before it is removed. Most transplant units have schedule to remove the ureteric stent ranging from 7 days to 12 weeks. Therefore, the aims of this study are to investigate the outcomes of early removal of a ureteric stent simultaneously with removal of indwelling urethral catheter (IDC). The surgical procedure will be slightly modified, in which a 4/0 suture string is used for connection of the stent with the tip of urethral catheter. As such, the stent will be removed by the string following removal of the urethral catheter.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 79 Yearss

Plain Language Summary

Simplified for easier understanding

Kidney transplantation is life-changing for people with kidney failure, but the surgery involves placing a small plastic tube (a ureteric stent) inside the tube that drains urine from the new kidney to the bladder. This stent reduces the risk of urine leaks and blockages — but it also causes problems of its own, including urinary tract infections and irritation, and requires a separate procedure under anaesthetic to remove it weeks later. This study is testing whether the stent can be removed much earlier — at the same time as the urinary catheter is taken out (usually within a week of the transplant) — by attaching a fine thread to the stent during surgery so it can simply be pulled out without any additional procedure. The researchers want to find out if this approach is safe and reduces stent-related complications. You may be eligible if you are between 18 and 79 years old and scheduled to receive a kidney transplant. You should not have a history of major bladder surgery (such as bladder removal or urinary diversion). Participants must be willing to attend follow-up appointments at the renal clinic. This study offers a potential way to make the post-transplant recovery period more comfortable.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

In Kidney transplantation, placement of a ureteric stent (a plastic tube) in the ureter is beneficial, which will reduce urinary tract complications such as urine leakage from the site of anastomosis

In Kidney transplantation, placement of a ureteric stent (a plastic tube) in the ureter is beneficial, which will reduce urinary tract complications such as urine leakage from the site of anastomosis and ureteric stenosis. The ureteric stent is usually removed 4-6 weeks after surgery by a procedure of cystoscopy in operating theatre requiring a hospital admission. On the other hand, the presence of a ureteric stent is associated with some increased risk of urinary tract infection, encrustation resulting in ureteric obstruction as well as increased risk of BK virus infection, which can cause long term kidney damage and kidney graft loss. Furthermore, as alluded to above, removal of a ureteric stent requires a day admission to hospital with additional surgical procedure that is adding the cost to health care system. The aim of this study is to refine the kidney transplant procedure, in which the ureteric stent is connected to the tip of indwelling urethral catheter by a suture string at the time implantation and kidney transplantation by the transplant surgeon. In this way, the ureteric stent can be removed at the same time of removal of urethral indwelling catheter at day 4-5 post surgery. The participants will be recruited from the wait list of kidney transplantation in our institute and an informed consent will be obtained. The data will be collected with respect to surgical complications including urine leakage, ureteric narrowing, urinary tract infection, ureteric blockage, BK virus infection and kidney graft function. The outcomes will be compared with historical control, in which the ureteric stent was routinely removed by cystoscopy 4-6 weeks post transplantation. This project will be expected to benefit patient quality of life and reduce the cost to health care system by not requiring hospital admission for removal of stent as well as reduce the incidence of urinary tract infection, stent encrustation, ureteric obstruction and BK virus infection.

Locations(1)

Sir Charles Gairdner Hospital - Nedlands

WA, Australia

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ACTRN12618000737235