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Double J Stent With Antireflux Device in the Prevention of Short-Term Urological Complications After Cadaveric Kidney Transplantation: Single-Center Prospective Randomized Study
Double J Stent With Antireflux Device in the Prevention of Short-Term Urological Complications After Cadaveric Kidney Transplantation: Single-Center Prospective Randomized Study M. Battaglia, P. Ditonno, O. Selvaggio, S. Palazzo, C. Bettocchi, R. Peschechera, S. Di Paolo, G. Stallone, A. Schena, G. Grandaliano, E. D’Orazio, and F.P. Selvaggi ABSTRACT The placement of a double J stent to protect a uretero-vesical anastomosis in a kidney transplant is a widespread procedure performed to reduce the incidence of fistula and stenosis at the anastomosis. However, the presence of a double J stent may cause vesicoureteral reflux (VUR), predisposing one to urinary tract infections (UTIs), which may be a significant source of morbidity for the graft. We evaluated whether a ureteral stent incorporating an antireflux device can reduce the incidence of ureteral reflux and UTIs. From January to December 2003, 44 kidney transplant recipients were randomized to receive a 14-cm 4.8-F double J stent with (group A) or without an anti-reflux device (group B). Primary end points were the reduction of the incidence of VUR and of UTIs. The secondary end point was the graft function, on the basis of mean serum creatinine level at 3, 6, and 12 months. We failed to observe statistically significant differences in terms of either the incidence of VUR and UTIs, or the short-term outcomes of the grafts. We concluded that the anti-reflux device does not have an impact on the incidence of stent-related side effects.
T
HE MOST common urological complications in kidney transplantation involve the ureteroneocystostomy. Their incidence rate has decreased from 20% in the 1970s to 5% in the 1990s due to improvements in surgical technique, reduction of steroid doses, and introduction of the double J stent.1,2 However, the presence of a double J stent can cause vesicoureteral reflux (VUR) and may predispose one to the onset of urinary tract infections (UTIs) in the postoperative period when the immunosuppressive regimen is at its peak. In the early postoperative period, VUR and UTIs may be a significant source of morbidity for the graft.3 In an effort to reduce the incidence of these complications, we performed a single-center prospective randomized study in a renal transplant population to verify the efficacy of an anti-reflux device incorporated in the double J ureteral stent (Fig 1). MATERIALS AND METHODS From January to December 2003, renal transplant recipients were recruited to this study when they fulfilled the inclusion criteria: adult cadaveric transplants; ureteroneocystostomy performed using only the Lich-Gregoire technique; and good bladder compliance in the absence of outlet obstruction. Each recipient was randomized
to receive a pediatric 4.8 F double J stent (C.R. Bard, Inc., Covington, Ga) with (group A) or without an anti-reflux device (group B). Primary end points were different in VUR or UTIs between the 2 groups. The secondary end point was the short-term graft outcome evaluated on the basis of mean serum creatinine level at 3, 6, and 12 months. The presence of VUR was evaluated by voiding renal ultrasonography (US) and, if clinically indicated, by voiding cystourethrography (VCUG). The period of observation lasted 1 month until removal of the double stent.
RESULTS
From January to December 2003, among 77 cadaveric kidney transplants, 44 recipients were selected on the basis of the inclusion criteria (group A, 22 patients; group B, 22 patients). Mean donor age was 47 years (range, 27–75); mean cold ischemia time was 16 ⫾ 5 and 18 ⫾ 4 hours in From the Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. Address reprint requests to Prof. Michele Battaglia, Dipartimento dell’Emergenza e dei Trapianti d’Organo, - Sez. Urologia 1a e Trapianto Rene, P.zza G. Cesare, 11, 70124 Bari, Italy. E-mail: [email protected]
© 2005 by Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010-1710
0041-1345/05/$–see front matter doi:10.1016/j.transproceed.2005.06.107
Transplantation Proceedings, 37, 2525–2526 (2005)
2525
2526
BATTAGLIA, DITONNO, SELVAGGIO ET AL
Fig 1.
The anti-reflux device incorporated in the double J stent.
groups A and B, respectively. Mean recipient age was 41.8 years (range, 26 – 64) and 45.3 years (range, 25– 61) in groups A and B, respectively. Ureteral stents were uniformly removed after 30 days from surgery. There were 4 retransplantations; 3 in group A and 1 in group B. No evidence of VUR occurred in either group, evaluated using US. In group A, 5 cases and in group B only 2 cases of UTI were observed (P ⫽ not significant [NS]). Mean serum creatinine level was 1.6 ⫾ 0.6 and 1.7 ⫾ 0.6 after 3 months; 1.4 ⫾ 0.4 and 1.7 ⫾ 0.5 after 6 months; 1.3 ⫾ 0.4 and 1.4 ⫾ 0.5 after 12 months, in groups A and B, respectively (P ⫽ NS). DISCUSSION
A properly performed Lich-Gregoire antireflux ureteroneocystostomy, with a ureteral tunnel at least 2 cm long and a double J stent, seems to obtain the best prevention of
VUR, UTIs, and ascending pyelonephritis in the transplanted kidney. The incorporation of an antireflux device on the double J stent does not change the incidence of VUR and UTIs and does not seem necessary to improve the outcome of Lich-Gregoire ureteroneocystostomy. REFERENCES 1. Kumar A, Balbir S, Srivastava A, et al: Evaluation of the urological complications of living related renal transplantation at a single center during the last 10 years: impact of the double J stent. J Urol 164:657, 2000 2. Gibbons W, Barry J, Hefty T: Complications following unstented parallel incision extravesical ureteroneocystostomy in 1,000 kidney transplants. J Urol 148:38, 1992 3. Streeter EH, Little DM, Cranston DW, et al: The urological complications of renal transplantation: a series of 1535 patients. BJU Int 90:627, 2002
T
HE MOST common urological complications in kidney transplantation involve the ureteroneocystostomy. Their incidence rate has decreased from 20% in the 1970s to 5% in the 1990s due to improvements in surgical technique, reduction of steroid doses, and introduction of the double J stent.1,2 However, the presence of a double J stent can cause vesicoureteral reflux (VUR) and may predispose one to the onset of urinary tract infections (UTIs) in the postoperative period when the immunosuppressive regimen is at its peak. In the early postoperative period, VUR and UTIs may be a significant source of morbidity for the graft.3 In an effort to reduce the incidence of these complications, we performed a single-center prospective randomized study in a renal transplant population to verify the efficacy of an anti-reflux device incorporated in the double J ureteral stent (Fig 1). MATERIALS AND METHODS From January to December 2003, renal transplant recipients were recruited to this study when they fulfilled the inclusion criteria: adult cadaveric transplants; ureteroneocystostomy performed using only the Lich-Gregoire technique; and good bladder compliance in the absence of outlet obstruction. Each recipient was randomized
to receive a pediatric 4.8 F double J stent (C.R. Bard, Inc., Covington, Ga) with (group A) or without an anti-reflux device (group B). Primary end points were different in VUR or UTIs between the 2 groups. The secondary end point was the short-term graft outcome evaluated on the basis of mean serum creatinine level at 3, 6, and 12 months. The presence of VUR was evaluated by voiding renal ultrasonography (US) and, if clinically indicated, by voiding cystourethrography (VCUG). The period of observation lasted 1 month until removal of the double stent.
RESULTS
From January to December 2003, among 77 cadaveric kidney transplants, 44 recipients were selected on the basis of the inclusion criteria (group A, 22 patients; group B, 22 patients). Mean donor age was 47 years (range, 27–75); mean cold ischemia time was 16 ⫾ 5 and 18 ⫾ 4 hours in From the Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy. Address reprint requests to Prof. Michele Battaglia, Dipartimento dell’Emergenza e dei Trapianti d’Organo, - Sez. Urologia 1a e Trapianto Rene, P.zza G. Cesare, 11, 70124 Bari, Italy. E-mail: [email protected]
© 2005 by Elsevier Inc. All rights reserved. 360 Park Avenue South, New York, NY 10010-1710
0041-1345/05/$–see front matter doi:10.1016/j.transproceed.2005.06.107
Transplantation Proceedings, 37, 2525–2526 (2005)
2525
2526
BATTAGLIA, DITONNO, SELVAGGIO ET AL
Fig 1.
The anti-reflux device incorporated in the double J stent.
groups A and B, respectively. Mean recipient age was 41.8 years (range, 26 – 64) and 45.3 years (range, 25– 61) in groups A and B, respectively. Ureteral stents were uniformly removed after 30 days from surgery. There were 4 retransplantations; 3 in group A and 1 in group B. No evidence of VUR occurred in either group, evaluated using US. In group A, 5 cases and in group B only 2 cases of UTI were observed (P ⫽ not significant [NS]). Mean serum creatinine level was 1.6 ⫾ 0.6 and 1.7 ⫾ 0.6 after 3 months; 1.4 ⫾ 0.4 and 1.7 ⫾ 0.5 after 6 months; 1.3 ⫾ 0.4 and 1.4 ⫾ 0.5 after 12 months, in groups A and B, respectively (P ⫽ NS). DISCUSSION
A properly performed Lich-Gregoire antireflux ureteroneocystostomy, with a ureteral tunnel at least 2 cm long and a double J stent, seems to obtain the best prevention of
VUR, UTIs, and ascending pyelonephritis in the transplanted kidney. The incorporation of an antireflux device on the double J stent does not change the incidence of VUR and UTIs and does not seem necessary to improve the outcome of Lich-Gregoire ureteroneocystostomy. REFERENCES 1. Kumar A, Balbir S, Srivastava A, et al: Evaluation of the urological complications of living related renal transplantation at a single center during the last 10 years: impact of the double J stent. J Urol 164:657, 2000 2. Gibbons W, Barry J, Hefty T: Complications following unstented parallel incision extravesical ureteroneocystostomy in 1,000 kidney transplants. J Urol 148:38, 1992 3. Streeter EH, Little DM, Cranston DW, et al: The urological complications of renal transplantation: a series of 1535 patients. BJU Int 90:627, 2002