UNILATERAL EXTRAVESICAL URETERAL REIMPLANTATION IN CHILDREN PERFORMED ON AN OUTPATIENT BASIS

UNILATERAL EXTRAVESICAL URETERAL REIMPLANTATION IN CHILDREN PERFORMED ON AN OUTPATIENT BASIS

0022-5347/05/1745-1987/0 THE JOURNAL OF UROLOGY® Copyright © 2005 by AMERICAN UROLOGICAL ASSOCIATION Vol. 174, 1987–1990, November 2005 Printed in U...

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0022-5347/05/1745-1987/0 THE JOURNAL OF UROLOGY® Copyright © 2005 by AMERICAN UROLOGICAL ASSOCIATION

Vol. 174, 1987–1990, November 2005 Printed in U.S.A.

DOI: 10.1097/01.ju.0000176795.96815.43

UNILATERAL EXTRAVESICAL URETERAL REIMPLANTATION IN CHILDREN PERFORMED ON AN OUTPATIENT BASIS SCOTT PUTMAN, CHRISTOPHER WICHER, ROBERT WAYMENT, BRUCE HARRELL, CATHERINE DEVRIES, BRENT SNOW AND PATRICK CARTWRIGHT From the Division of Urology, University of Utah, Salt Lake City, Utah

ABSTRACT

Purpose: Unilateral extravesical ureteral reimplantation is comparable to intravesical procedures for resolution of primary vesicoureteral reflux (VUR). Defining whether this operation can be consistently performed on an outpatient basis is important. Materials and Methods: A total of 80 patients with unilateral VUR were treated with extravesical ureteral reimplantation, of whom 20 were treated on an inpatient basis and 60 on an outpatient basis. We retrospectively reviewed these groups and conducted a telephone survey to evaluate overall patient satisfaction, and pain and nausea on postoperative days 1 and 14. Results: There were no significant differences in age, gender, laterality or operative time between the groups. Average length of hospital stay was 31.25 hours (range 20 to 120) for the inpatient group and 6.6 hours (3.25 to 11.20) for the outpatient group. Average intravenous narcotic use in the inpatient group was 0.39 mg/kg, compared to 0.14 mg/kg for the outpatient group (p ⬍0.005), and included 1.76 mg/kg ketorolac in inpatients and 0.74 ketorolac in outpatients (p ⬍0.005), and 0.2 mg/kg ondansetron in inpatients and 0.12 mg/kg ondansetron in outpatients (p ⫽ 0.004). Four of the 60 outpatients (6.7%) were either hospitalized postoperatively or rehospitalized on postoperative day 1. The results of the survey for the 2 groups were not significantly different. Conclusions: Extravesical ureteral reimplantation for unilateral VUR may be performed without compromise in quality on an outpatient basis with significantly less use of intravenous analgesics and anti-emetics. KEY WORDS: ureter; urologic surgical procedures; anastomosis, surgical; vesico-ureteral reflux

Ureteral reimplantation is an accepted method of surgical therapy for vesicoureteral reflux (VUR), with a durable success rate of more than 90%.1 Specifically, the extravesical technique of ureteral reimplantation pioneered by Lich in America and Gregoir in Europe in the 1960s has proved to be an excellent alternative to intravesical techniques for unilateral VUR, with a success rate of 90% to 99%.2– 4 The LichGregoir technique is also considered a less morbid technique than intravesical ureteral reimplantation, as it spares the patient from undergoing cystostomy and direct manipulation of the urothelium.5 The current state of medical economics has encouraged physicians to streamline medical costs while maintaining consistent, excellent care, which has resulted in a trend of traditionally inpatient procedures being performed on an outpatient basis.6 – 8 We consider the Lich-Gregoir extravesical unilateral ureteral reimplantation technique to be an excellent procedure for outpatient treatment, and report our experience with the first 60 patients at our institution treated on an outpatient basis, comparing the results to 20 consecutive inpatient procedures. MATERIALS AND METHODS

A total of 80 unilateral extravesical ureteral reimplantations were performed by 3 pediatric urologists (BS, CD, PC) between December 2002 and July 2004. These cases were retrospectively evaluated. Of these procedures 20 were performed on an inpatient basis during the early part of the study period. These patients were hospitalized postoperatively and stayed at least 1 night in the hospital. The remaining 60 patients were treated on an outpatient basis. These patients were admitted to the hospital, underwent the proSubmitted for publication February 2, 2005.

cedure, stayed for a short time in the post-anesthesia care unit and were observed in a standard postoperative unit until ready for discharge home. All 80 patients had primary reflux, and surgery was performed for breakthrough urinary tract infections or high grade VUR unlikely to resolve with time. Patient characteristics were similar in each group (table 1). All children in the inpatient group underwent unilateral extravesical ureteral reimplantation as described by LichGregoir. No catheters or drains were used. Local anesthesia consisting of 0.25% bupivacaine was provided subcutaneously before and after the procedure for 18 patients (90%). Two patients (10%) received 1-shot caudal analgesia. The patients were given a range of narcotic analgesics, nonsteroidal anti-inflammatory drugs and anti-emetics intraoperatively, according to the preference of the anesthesiologist. A total of 17 patients (85%) were given a narcotic drip, which consisted of nalbuphine or morphine, and 3 (15%) were given morphine or nalbuphine on demand. The narcotic drip was run continuously and the drip velocity was titrated based on individual pain level. All patients receiving narcotic drip were weaned off of intravenous narcotics by 10 to 18 hours postoperatively. All patients received intravenous (IV) ketorolac every 8 hours until discharge from the hospital. Ondansetron was given on an as needed basis for nausea or vomiting. Discharge parameters included pain controlled with an oral analgesic, adequate spontaneous voiding, and ability to eat and drink without nausea or vomiting. The patients were discharged home with oral hydrocodone-acetaminophen and prophylactic antibiotics. Approximately 1 month after discharge home patients returned to the clinic for retroperitoneal ultrasound to evaluate for obstruction. At least 6 weeks

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OUTPATIENT EXTRAVESICAL URETERAL REIMPLANTATION IN CHILDREN TABLE 1. Patient characteristics Inpatients (20) Outpatients (60) p Value

Mean pt. age (mo/range) Mean degree reflux (range) %M %F % Lt reflux % Rt reflux

70.4 (24–153) 3.3 (2–4) 20 80 60 40

61.4 (10–153) 3 (1–5) 10 90 55 45

0.5 0.16 0.1 0.1 0.44 0.44

after surgery a telephone survey was performed, which contained 5 questions. Parents of the patients were asked to rate overall satisfaction with their experience at the hospital on a scale of 0 to 10, with 0 being completely dissatisfied and 10 being completely satisfied. The 0 to 10 Numeric Rating Scale, on which 0 equals no pain while 10 represents the worst possible pain, was used to evaluate pain on postoperative days 1 and 14. Patients younger than 3 years were assessed with the Face, Legs, Activity, Cry, Consolability, Pain Scale, a similar validated pain scale.9 A similar scale was used to evaluate degree of nausea on postoperative days 1 and 14. The outpatient group consisted of the first 60 consecutive children treated with extravesical reimplantation on an outpatient basis. A total of 54 patients (90%) underwent LichGregoir extravesical ureteral reimplantation, of whom 6 (11%) received a contralateral subureteral injection of dextranomer/hyaluronic acid copolymer for reflux that had resolved on that side. The remaining 6 patients (10%) underwent dismembered extravesical ureteral reimplantation if the submucosal tunnel alone was inadequate for resolution of reflux. As in the inpatient group, no catheters or drains were used. Parents were counseled preoperatively with the expectation that their child would be able to go home on the day of surgery. Of the 60 patients in this group 55 (92%) received 0.25% bupivacaine subcutaneously as local anesthesia before and after the procedure, while 5 (8%) received 1-shot caudal anesthesia preoperatively. Again, various narcotic analgesics, nonsteroidal anti-inflammatory drugs and anti-emetics, including morphine, nalbuphine, fentanyl, ketorolac, dexamethasone and ondansetron, were given according to the preference of the anesthesiologist. Discharge criteria were similar to those for the inpatient group. Patients returned to the clinic approximately 1 month postoperatively for retroperitoneal ultrasound, as in the inpatient group. The same telephone survey was administered to the outpatient group at least 6 weeks postoperatively. A 2-sample nonpaired Student t test was used to evaluate any statistically significant difference (p ⬍0.05) in the characteristics and results of the 2 groups. RESULTS

Table 2 shows a comparison of the inpatient and outpatient reimplantation groups for operative time, length of stay, pain and nausea/vomiting on days 1 and 14, as well as overall patient satisfaction. Length of stay was predictably shorter in the outpatient group in a highly statistically significant

manner. Nausea and vomiting at 14 days was more common in the outpatient procedure but just reached statistical significance. Intravenous use of narcotics, ketorolac and ondansetron is summarized in table 3. Morphine and nalbuphine are considered together in that many patients given morphine intraoperatively were then placed on a nalbuphine drip postoperatively and these 2 narcotics are dosed similarly. The inpatient group used a significantly greater amount of narcotic, ketorolac and ondansetron than the outpatient group. No inpatients were rehospitalized after being discharged home. Four of the 60 outpatients (6.7%) either were admitted to the hospital from the postoperative unit for failing to meet discharge criteria or were readmitted after discharge.1, 3 Of the 3 patients admitted to the hospital from the postoperative unit 2 had nausea and vomiting, and required IV antiemetics and hydration, and 1 was diagnosed as having an adverse reaction to hydrocodone. These patients were all discharged home the following day, and, therefore, data on length of stay and other parameters were not calculated with the overall outpatient group. One patient was seen at the emergency room on postoperative day 1 with pain not controlled by oral analgesia. This patient was hospitalized for IV pain control and was discharged home the following day. DISCUSSION

Open abdominal procedures have traditionally been considered inpatient procedures, requiring at least an overnight stay for observation and intravenous narcotics. With the advent of minimally invasive surgical techniques and advanced techniques in anesthesia there has been a trend in surgery to shorten the hospital stay and convert some inpatient procedures to the outpatient setting. Pediatric urology has successfully followed this trend, treating ureteral reimplantations, nephrectomies and pyeloplasties as outpatient procedures at certain select centers.6 – 8 While the contributions these changes make to health care costs are obvious, patient care must not be compromised. On the other hand, hospitalization in the pediatric population has been observed to have adverse psychological effects.10 We have attempted to illustrate that unilateral extravesical ureteral reimplantation may be considered an outpatient procedure with no compromise in quality of patient care or patient/parent satisfaction. There are existing reports of extravesical and intravesical reimplantation treated on an outpatient basis.8, 11 Most notably, Marotte and Smith treated 44 patients undergoing ureteral reimplantation for VUR as outpatients.11 Bilateral extravesical reimplantation was performed in approximately half of the patients and half underwent unilateral reimplantation. Average length of stay in this study was 13.3 hours (range 5 to 30) and approximately 30% of the patients were admitted to the hospital as inpatients. We found that outpatient unilateral reimplantation resulted in only a 6 to 7-hour stay in the hospital from admission to discharge. This length of time more closely reflects the expected stay for other standard outpatient procedures. Our hospitalization/rehospitalization rate of 6.7% is higher than that for many outpatient procedures. Parents may be counseled that there is a 7% chance that their child will stay in

TABLE 2. Results Mean (range)

Operative mins (range) Hrs hospitalization Pain score postop day 1 Pain score postop day 14 Nausea/vomiting score postop day 1 Nausea/vomiting score postop day 14 Overall pt satisfaction score

Inpatients

Outpatients

67 (46–115) 31.25 (20–120) 5.5 (0–10) 0.9 (0–4) 1.8 (0–10) 0 (0) 9.1 (5–10)

69 (40–145) 6.6 (3.25–11.2) 4.9 (2–10) 0.4 (0–3) 2.3 (0–9) 0.3 (0–2) 9.1 (6–10)

TABLE 3. Use of intravenous narcotic (nalbuphine or morphine), ketorolac and ondansetron

Narcotic Ketorolac Ondansetron

Inpatients (av mg/kg)

Outpatients (av mg/kg)

p Value

0.39 1.76 0.2

0.14 0.74 0.12

⬍0.005 ⬍0.005 —

OUTPATIENT EXTRAVESICAL URETERAL REIMPLANTATION IN CHILDREN

the hospital overnight. Parental expectations are a key element, and most parents have no problem accepting that in more than 9 of 10 procedures a child will be fine to go home the day of surgery. As evidenced by the telephone survey, there was no significant difference in parent perception of patient pain, nor was parent perception of the overall experience diminished. The 80 patients evaluated were all treated for unilateral VUR. In cases of bilateral VUR we have generally performed intravesical ureteral reimplantation. Bilateral extravesical reimplantation has been found to cause urinary retention and this outcome has been our experience as well.12 Therefore, we limited our outpatient correction of VUR to unilateral cases. However, modifications to the Lich-Gregoir technique, so as to spare the detrusor innervation, may allow extravesical surgical therapy for bilateral VUR without the threat of problematic urinary retention.13 The use of intravenous analgesia and anti-emetics was significantly higher in the inpatient group than in outpatients. However, the difference in pain and nausea levels between the 2 groups was not significantly different. While this finding may be explained by the psychological effect of being hospitalized, the true amount of delivered narcotic was not measured. The amount of oral analgesia taken in the first 24 hours by the outpatient group was certainly higher in that they began taking hydrocodone/acetaminophen within 1 to 2 hours of the procedure and the inpatient group was switched to oral analgesia after 10 to 18 hours. A comparison of the amount of total analgesia used was not evaluated here. This study suggests that intravenous narcotics may only be necessary during the intraoperative period and oral analgesia is sufficient postoperatively for this procedure. A single dose of ketorolac may also be sufficient postoperatively, rather than scheduled ketorolac until discharge from the hospital. There are several limitations to this study. The telephone survey contained some questions that have not been validated. Although the questions about overall satisfaction and level of nausea/vomiting were based on the Numeric Rating Scale for pain, which is a validated instrument regarding intensity of pain, this rating system has not been validated for satisfaction and nausea/vomiting. There may also be an element of recall bias in that patients and parents were asked to assess pain, nausea and vomiting at 2 weeks and sometimes as long as 6 weeks after surgery. It is also difficult to compare oral intake of narcotic analgesia by group. It is easy to monitor inpatient use of narcotics but the outpatient group was taking hydrocodone/acetaminophen on an as needed basis and often alternated ibuprofen with hydrocodone/acetaminophen or did not take hydrocodone/acetaminophen at all after discharge from the hospital. Most parents could not recall the exact schedule of oral analgesia postoperatively. While we have found that patients with unilateral vesicoureteral reflux may be treated on an outpatient basis with open extravesical ureteral reimplantation, subureteral injection of dextranomer/hyaluronic acid copolymer is also an acceptable outpatient alternative. Kirsch et al observed an overall resolution rate of 72% in 134 patients with all grades of vesicoureteral reflux in 2003.14 More recently, Kirsch et al have developed a modified endoscopic procedure that has resolution rates of 89% for VUR grades 1 to 4.15 The newer procedure requires a short anesthesia time, minimal postoperative narcotics and a short (2 to 3-hour) hospital stay. However, there are some drawbacks to endoscopic subureteral injections. The long-term safety and efficacy of subureteral injection with dextranomer/hyaluronic acid copolymer has not been established. At its best this procedure yields resolution rates of 89% for VUR grades 1 to 4 in contrast to open extravesical reimplantation, which has established resolution rates of 94% to 99% for all grades of VUR in current series.

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CONCLUSIONS

Unilateral extravesical reimplantation is an appropriate procedure to perform on an outpatient basis. We compared 2 groups of patients undergoing unilateral extravesical ureteral reimplantation with and without postoperative admission to the hospital. Given our method of treatment, 6% to 7% of patients designated for outpatient reimplantation will require an overnight stay. The remaining 93% to 94% can be discharged home within a few hours after surgery. There were no clinically significant differences in the results of the telephone survey. The parents of patients in both groups were equally satisfied with the overall experience. There was also no difference in the level of pain, nausea or vomiting between the 2 groups. We have demonstrated that unilateral extravesical ureteral reimplantation for primary VUR may be successfully performed on an outpatient basis, avoiding the cost and psychological stress of spending a night in the hospital.

REFERENCES

1. Duckett, J. W., Walker, R. D. and Weiss, R.: Surgical results: International Reflux Study in Children—United States branch. J Urol, 148: 1674, 1992 2. Gregoir, W. and Schulman, C. C.: Extravesical antirefluxplasty. Urologe A, 16: 124, 1977 3. Heimbach, D., Bruhl, P. and Mallmann, R.: Lich-Gregoir antireflux procedure; indications and results with 283 vesicoureteral units. Scand J Urol Nephrol, 29: 311, 1995 4. Arap, S., Abrao, E. G. and Menezes de Goes, G.: Treatment and prevention of complications after extravesical antireflux technique. Eur Urol, 7: 263, 1981 5. Ellsworth, P. I. and Merguerian, P. A.: Detrusorrhaphy for the repair of vesicoureteral reflux: comparison with the Leadbetter-Politano ureteroneocystostomy. J Pediatr Surg, 30: 600, 1995 6. Gonzalez, A. and Smith, D. P.: Minimizing hospital length of stay in children undergoing ureteroneocystostomy. Urology, 52: 501, 1998 7. Kogan, B. A., Baskin, L. S. and Allison, M. J.: Length of stay for specialized pediatric urologic care. Arch Pediatr Adolesc Med, 152: 1126, 1998 8. Sprunger, J. K., Reese, C. T. and Decter, R. M.: Can standard open pediatric urological procedures be performed on an outpatient basis? J Urol, 166: 1062, 2001 9. Manworren, R. C. and Hynan, L. S.: Clinical validation of FLACC: preverbal patient pain scale. Pediatr Nurs, 29: 140, 2003 10. Wright, M. C.: Behavioural effects of hospitalization in children. J Paediatr Child Health, 31: 165, 1995 11. Marotte, J. B. and Smith, D. P.: Extravesical ureteral reimplantations for the correction of primary reflux can be done as outpatient procedures. J Urol, 165: 2228, 2001 12. Lipski, B. A., Mitchell, M. E. and Burns, M. W.: Voiding dysfunction after bilateral extravesical ureteral reimplantation. J Urol, 159: 1019, 1998 13. David, S., Kelly, C. and Poppas, D. P.: Nerve sparing extravesical repair of bilateral vesicoureteral reflux: description of technique and evaluation of urinary retention. J Urol, part 2, 172: 1617, 2004 14. Kirsch, A. J., Perez-Brayfield, M. R. and Scherz, H. C.: Minimally invasive treatment of vesicoureteral reflux with endoscopic injection of dextranomer/hyaluronic acid copolymer: the Children’s Hospitals of Atlanta experience. J Urol, 170: 211, 2003 15. Kirsch, A. J., Perez-Brayfield, M., Smith, E. A. and Scherz, H. C.: The modified sting procedure to correct vesicoureteral reflux: improved results with submucosal implantation within the intramural ureter. J Urol, 171: 2413, 2004 EDITORIAL COMMENT The historical 3 to 7-day hospitalization for anti-reflux surgery has evolved into the “1-day stay,” then the “23-hour observation” and finally the realization of a true “outpatient surgery.” This paradigm

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shift has been realized by better anesthesia/analgesics, limited use of bladder catheters/drains, and smaller incisions and improved operative times. The goal of any procedure would be 100% success with no morbidity. Unfortunately, none of the antireflux procedures meets these criteria. The conclusion that open reimplantation is feasible on an outpatient basis is supported by the experience of the authors. The practicality of such an approach is highly individualized, and one should question the high rehospitalization rate of nearly 7% for any outpatient surgery. The excellent result of endoscopic surgery (80% to 90% cure) weakens the case for any open approach for up to grade IV VUR. However, as shown by the authors, when failures occur extravesical reimplantation on an outpatient basis may be offered in selected patients. In most instances parents will find comfort in the knowledge that their child will not need hospitalization. Others will feel quite the opposite. However, based on the limitations of this approach (cost, morbidity, scarring) and the high family satisfaction with endoscopic treatment, it would seem that this protocol should be relegated to a limited subset of children.

Andrew J. Kirsch Department of Pediatric Urology Children’s Healthcare of Atlanta Emory University School of Medicine Atlanta, Georgia REPLY BY AUTHORS We agree that subureteral Deflux™ injection is useful to treat reflux. However, we do not view 80% to 90% success as excellent. Neither do many parents in our experience, as they decide what treatment to choose if observation has failed. Many want the option with the highest chance of resolution, which currently is open reimplant. Based on our article, we tell families to expect 9 of 10 children to go home the same day after open (unilateral) reimplant vs almost all after injection. The scar from open reimplant is small and low with minimal long-term cosmetic concerns as it hides within pubic hair. At our hospital injection is more costly than open reimplant on outpatient due largely to the cost of Deflux™. Given all of this, it is not clear to us that injection is a better option than open reimplant to treat unilateral reflux.