Prophylactic Ureteric Stents in Renal Transplant Recipients: A Multicenter Randomized Controlled Trial of Early Versus Late Removal
Prophylactic ureteric stenting in renal transplantation reduces major urological complications; however, morbidity is related to the indwelling duration of a stent. We aimed to determine the optimal duration for stents in this clinical setting. Patients (aged 2-75 years) from six UK hospitals who were undergoing renal transplantation were recruited and randomly assigned to either early stent removal at 5 days (without cystoscopy) or late removal at 6 weeks after transplantation (with cystoscopy). The primary outcome was a composite of stent-related complications defined as pain, visible hematuria, migration, fragmentation, and urinary tract infections (UTIs) within 3 mo of transplantation. Between May 2010 and Nov 2013, we randomly assigned 227 participants, with 205 included in the final analysis of the primary outcome. Stent-related complications were significantly higher in the late versus early stent removal groups (36 of 126 [28.6%] vs. 6 of 79 [7.6%]; p < 0.001). The majority of stent complications consisted of UTIs, with an incidence of 31 of 126 (24.6%) in the late group compared with 6 of 79 (7.6%) in the early group (p = 0.004). We found early stent removal on day 5 significantly reduced stent-related complications and improved quality of life in the first 3 mo after transplantation (ISRCTN09184595).
CET Conclusion
| Reviewer: | Mr Simon Knight, Centre for Evidence in Transplantation, The Royal College of Surgeons of England. |
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| Conclusion: | This interesting study investigated the impact of early (day 5) versus late (week 6) ureteric stent removal in adult and paediatric renal transplant recipients. The authors report increased incidence of stent-related complications with late removal, mainly due to increased incidence of urinary tract infection, supporting the early removal of stents. It should be noted that there was a numerical (but not significant) increase in major and intermediate ureteric complications (stenosis, leak, temporary obstruction) in the early removal group. Whilst the results appear to support the early removal of stents, there are some limitations to note. Firstly, a number of randomised patients did not undergo early removal due to technical difficulties connecting the stent to the catheter. When analysed as intent-to-treat, the difference in stent-related complications did not quite reach significance. This may represent a technical learning curve and be improved with more experience. Secondly, whilst there was a protocol for urine sampling for infection and a clear definition provided, the number of samples analysed in each group is not reported. As the study is unblinded, it is possible that some measurement bias exists. Finally, longer-term follow-up for late ureteric stenoses will be important to ensure that there are no long-term effects of early removal. |
Expert Review
| Reviewer: | Professor Riadh A. S. Fadhil, Qatar Organ Donation Center, Hamad Medical Corporation, Doha. |
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| Conflicts of Interest: | No |
| Clinical Impact Rating | 3 |
| Review: | This multicentre randomised controlled trial was designed to investigate two groups: early- removal of the stent with the attached urethral catheter (5 days without cystoscopy) versus late-removal of the stent (6 weeks with cystoscopy). The study demonstrated that the early group had a significantly lower stent related complications (mainly the UTI) than the late group with low incidence of stent symptoms. However, the stent placement technique in the early group needed special attention and training curve, 15 cases were moved from the early to the late group due to technical difficulties in attaching stent to catheter. Although not statistically significant, incidence of major urological complications in the early group is higher than the late group. Six cases (7.6 %) of the early group needed further surgical intervention such as open surgical revision, nephrostomy or temporary stenting and some of these complications could have been prevented by longer stenting time. The evidence provided by this trial is not enough to make prophylactic stent users change their practice to the described early removal technique. The evidence could have been improved if a third group were included where the stent is removed in 2-4 weeks time and a longer-term follow up of the early group. |
Study Details
| Aims: | To determine the optimal duration for stent removal post renal transplantation. |
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| Interventions: | Participants were randomised to either early stent removal (on day 5 without cystoscopy) versus late stent removal (6 weeks with cystoscopy). |
| Participants: | 227 patients aged 2-75 years scheduled for renal transplantation. |
| Outcomes: | The primary outcome measured was a composite of transplant ureteric stent complications defined as pain, urinary tract infection, haematuria, fragmentation and migration. Secondary outcomes measured included major urological complications, health status and patient acceptability. |
| Follow Up: | 6 months |
Metadata
| Publication type: | Multicenter Study, Randomized Controlled Trial, Randomised Controlled Trial |
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| Organ: | Kidney |
| Language: | English |
| MeSH terms: | Adolescent; Adult; Aged; Child; Child, Preschool; Device Removal; Female; Follow-Up Studies; Glomerular Filtration Rate; Graft Rejection; Graft Survival; Humans; Kidney Failure, Chronic; Kidney Function Tests; Kidney Transplantation; Male; Middle Aged; Postoperative Complications; Prognosis; Quality of Life; Risk Factors; Stents; Time Factors; Transplant Recipients; Ureter; Urinary Tract Infections; Young Adult |