Factors That Influence Outcomes Of The Mitrofanoff And Malone Antegrade Continence Enema Reconstructive Procedures In Children

Factors That Influence Outcomes Of The Mitrofanoff And Malone Antegrade Continence Enema Reconstructive Procedures In Children

0022-5347/02/1684-1537/0 THE JOURNAL OF UROLOGY® Copyright © 2002 by AMERICAN UROLOGICAL ASSOCIATION, INC.® Vol. 168, 1537–1540, October 2002 Printed...

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0022-5347/02/1684-1537/0 THE JOURNAL OF UROLOGY® Copyright © 2002 by AMERICAN UROLOGICAL ASSOCIATION, INC.®

Vol. 168, 1537–1540, October 2002 Printed in U.S.A.

DOI: 10.1097/01.ju.0000028619.08733.7f

FACTORS THAT INFLUENCE OUTCOMES OF THE MITROFANOFF AND MALONE ANTEGRADE CONTINENCE ENEMA RECONSTRUCTIVE PROCEDURES IN CHILDREN TRAVIS CLARK, JOHN C. POPE, IV, MARK C. ADAMS, NANCY WELLS

AND

JOHN W. BROCK, III

From the Division of Pediatric Urology, Vanderbilt University Children’s Hospital, Nashville, Tennessee

ABSTRACT

Purpose: Surgical techniques that provide adequate urinary and fecal continence in children with neurogenic bladder and bowel dysfunction are becoming increasingly used. We reviewed our experience and discuss factors that influence outcome. Materials and Methods: Between 1994 and 2000, 65 stomal procedures were performed in 47 patients. For the urinary continent catheterizable channel we used appendix in 60% of cases, a continent bladder tube in 20%, a Yang-Monti tube in 16% and ureter in 4%. For the antegrade continence enema continent catheterizable channel we used appendix in 85% of cases, a YangMonti tube in 5% and a cecal tube in 10%. In the 19 patients who underwent simultaneous Mitrofanoff and antegrade continence enema procedures the urinary continent catheterizable channel was appendix in 21%, a Yang-Monti tube in 32% and continent vesicostomy in 47%. Patients were divided into 2 groups based on compliance status. In addition, percentile body weight for age was evaluated. Results: Stomal continence was achieved in 63 of the 65 cases (97%). Of the patients who underwent the antegrade continence enema procedure 95% achieved continence via the rectum. Except for ureter stenosis rates according to continent catheterizable channel type did not differ greatly, namely 19% for appendix, 11% for the Yang-Monti tube, 22% for the bladder tube, 50% for ureter and 0% for the cecal tube. Infectious complications developed in 16 patients and 4 had stones. The rates of infection (p ⫽ 0.004), stomal stenosis (p ⫽ 0.001) and revision (p ⫽ 0.004) were statistically lower in the compliant group and the stone formation rate showed a trend favoring the compliant group (p ⫽ 0.11). No significant difference was noted for incontinence. Percentile weight predicted a higher rate of stomal stenosis with the highest rate of stomal stenosis overall in the greater than 100th percentile group. Conclusions: The Mitrofanoff and antegrade continence enema procedures are reliable and effective. Proper patient selection and surgical technique with a tension-free anastomosis are essential. The choice of tissue for constructing the continent catheterizable channel is not as important as patient compliance, age and possibly body habitus. This report reinforces the importance of careful screening, and rigorous preoperative and postoperative teaching to achieve overall patient success. KEY WORDS: urinary diversion; bladder, neurogenic; stomas; urinary incontinence; transplantation

Providing continence mechanisms for patients with neurogenic bladder and bowel dysfunction is a rewarding endeavor. Due to the contributions of Mitrofanoff,1 Malone,2 Yang,3 Monti et al4 and others5, 6 many children with these disorders have achieved dramatic lifestyle improvement and prevention of renal deterioration. In the last 20 years significant strides have been made in improving the results of continence creating operations. Recently Liard et al suggested that the continent catheterizable cystostomy technique is durable provided that a low pressure reservoir is achieved.7 Other factors that may predict a successful outcome include proper patient selection, meticulous surgical technique and perhaps most importantly patient compliance. MATERIALS AND METHODS

We retrospectively reviewed the records of 65 continent catheterizable channel procedures performed in 47 patients between 1994 and 2000. Surgical efforts were directed toward the restoration of urinary and fecal continence, and improvement of lower urinary tract function. Patients were Accepted for publication May 24, 2002.

stratified into compliant and noncompliant groups based on the number of followup appointments missed and adherence to catheterization regimens. Greater than 2 missed followup appointments and/or documentation of noncompliance with catheterization protocol on greater than 2 occasions led to the assignment of a particular patient to the noncompliant group. We evaluated the rate of infection, incontinence, stomal stenosis, stone formation and need for revision in each compliance group. In addition, patients were stratified into 4 additional groups based on percentile weight using standard age-weight nomograms, including the less than 0 percentile (16) the 0 to 50th percentiles (13), the 51th to 100th percentiles (13) and the greater than 100th percentile (5). The Pearson chi-square test was used to determine the significance of reconstructive material on stomal stenosis rates and the Fisher exact test was used to analyze the effects of compliance on complication rates with p ⫽ 0.05 considered statistically significant. The Cochran Q statistic was used to evaluate the effect of skin incision on stomal stenosis. In addition, the Student t test was used to evaluate the relationship of mean age and compliance status with a standard error of 0.97 years.

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FACTORS THAT INFLUENCE RECONSTRUCTIVE PROCEDURES RESULTS

Mean patient age at reconstruction was 9.6 years (range of 3 to 19). Table 1 lists the diagnoses. Spinal dysraphism was identified in most patients. Followup was 1 to 72 months (mean of 22). As a urinary continent catheterizable channel, we used appendix in 27 surgical procedures (60%), a bladder tube in 9 (20%), a Yang-Monti tube in 7 (16%) and ureter in 2 (4%). As an antegrade continence enema continent catheterizable channel, we used appendix in 17 procedures, (85%), a Yang-Monti tube in 1 (5%) and a cecal tube in 2 (10%). In the 19 patients who underwent simultaneous Mitrofanoff and antegrade continence enema procedures the urinary continent catheterizable channel was appendix in 4 (21%), a YangMonti tube in 6 (32%) and a bladder tube in 9 (47%), while the fecal continent catheterizable channel was appendix in 16 (84%), a cecal tube in 2 (11%) and a Yang-Monti tube in 1 (5%). Additional simultaneous procedures were performed in 38 cases (81%), including bladder augmentation, bladder neck reconstruction, ureteral reimplantation and other. All patients underwent urodynamic evaluations preoperatively. After examining our data we observed that 31 of the 47 patients (66%) were compliant and 16 (34%) were noncompliant based on the stated definition. Complications developed in a minority of patients, mostly in the noncompliant group. A statistically significant difference in outcome based on compliance status was observed in most complication categories except for incontinence and stone formation. The figure shows an overview of the results. Stomal stenosis developed in 12 cases. Noncompliant patients were significantly more likely to have this complication than compliant patients (56% versus 10%, p ⫽ 0.001). The stenosis rate according to continent catheterizable channel type was 19% (8 of 43 patients) for appendix, (8/43), 11% (1 of 9) for the Yang-Monti tube, 22% (2 of 9) for the bladder tube, 50% (1 of 2) for ureter and 0% (0 of 2) for the cecal tube (table 2). These differences in the stenosis rate did not achieve statistical significance (p ⫽ 0.6). In 12 patients (26%) operative revision included stomal modification and/or reexploration. Noncompliant patients were significantly more likely to require operative revision (50% versus 10%, p ⫽ 0.004). We also evaluated the type of skin incisions for stomal formation and location. We used various incisions, including a V-flap in 34 of the 65 patients (52%), a star-shaped incision in 17 (26%) and a circular incision in 14 (22%), with an associated stomal stenosis rate of 12.1%, 17.6% and 35.7%, respectively (p ⫽ 0.22). For stomal location we selected the umbilicus in 33 cases (51%), right lower quadrant in 21 (32%) and left lower quadrant in 11 (17%). The observed stomal stenosis rate was 18% (6 of 33 cases) for the umbilicus, 24% (5 of 21) for the right lower quadrant and 9% (1 of 11) for the left lower quadrant. Obviously the choice of stomal location was somewhat limited by anatomical constraints. Percentile weight was associated with the stomal stenosis

TABLE 1 Diagnosis

No. Pts. (%)

Spina bifida Sacral agenesis Myelomeningocele Exstrophy Cloaca Posterior urethral valves VATER syndrome Reflux Filum terminale Hinman’s syndrome Prune-belly syndrome

23 (49) 7 (15) 6 (13) 4 (9) 2 (4) 2 (4) 2 (4) 2 (4) 1 (2) 1 (2) 1 (2)

Total No.

47 (100)

Complication rates for compliant and noncompliant patient groups.

TABLE 2. Stenosis rate according to continent catheterizable channel type Channel Type

No. Procedures (% stenosis)

Appendix Yang-Monti tube Bladder tube Ureter Cecal tube

43 (19) 9 (11) 9 (22) 2 (50) 2 (0)

rate, although the differences were not statistically significant. The highest stenosis rates were noted in the greater than 100th percentile weight group. The rate of stomal stenosis per weight category was 40% (2 of 5 patients) for the greater than 100th percentile, 31% (4 of 13) for the 51th to 100th percentiles, 15% (2 of 13) for the 0 to 50th percentiles and 31% (5 of 16) for the less than 0 percentile (p ⫽ 0.598). Patient age was evaluated to determine whether compliance status was associated with this variable. Average age in the compliant and noncompliant patient groups was 8.2 versus 12.2 years. This difference attained statistical significance (p ⫽ 0.002). Overall stomal continence was achieved in 63 of the 65 cases continent catheterizable channel (97%). Two patients with a bladder continent catheterizable channel had nonlifestyle changing incontinence via the stoma. Of those who underwent the antegrade continence enema procedure 95% achieved complete fecal continence and none had incontinence via the stoma. Only 1 patient had periodic fecal incontinence (1 episode weekly). Urinary incontinence developed in 17 of the 47 patients and the rate was higher in noncompliant than in compliant patients (44% versus 32%, p ⫽ 0.32). It should be stressed that 88% of incontinence occurred via the urethra and of all patients there was bothersome leakage in only 4 (9%). Infectious complications in 16 patients were associated with fever or required hospital admission in only 9. The infection rate was 63% and 19% in noncompliant and compliant patients, respectively (p ⫽ 0.004). Stones formed in 4 of 47 cases (9%). The calculous rate was 19% (3 of 13 patients) in the noncompliant group and 3% (1 of 31) in the compliant group (p ⫽ 0.108). DISCUSSION

With currently available reconstructive surgical techniques it is possible to achieve reliable urinary and fecal continence in the majority of appropriate pediatric patients. Operative technique, intraoperative decision making and proper patient selection have key roles in achieving this goal. A major focus of this report is to demonstrate the quantitative effects of patient compliance on postoperative complication rates. Complication rates were universally higher in the noncompliant patient group. Furthermore, we detected sta-

FACTORS THAT INFLUENCE RECONSTRUCTIVE PROCEDURES

tistically significant differences in the complication rate in the 2 compliance groups in the majority of complication categories, specifically infection, stomal stenosis and need for operative revision. Obviously factors other than compliance may also influence the complication rate. The choice of continent catheterizable channel type and stomal location depends on availability, body habitus and intraoperative findings. We did not note that the type of material chosen for the continent catheterizable channel affected the rate of stomal stenosis. Although stenosis rates varied, there was no statistically significant difference for a continent catheterizable channel of appendix, bladder, a Yang-Monti tube and so forth (p ⫽ 0.6). However, a larger sample size of ureter continent catheterizable channel cases, for example, may have shown a significant difference. Narayanaswamy et al believe that the Yang-Monti tube is inferior to appendix8 but we did not observe this finding in the current study. The patient and intraoperative situation dictate which continent catheterizable channel type is best in an individual. Any of the continent catheterizable channel alternatives may be acceptable in the appropriate situation and should be used without hesitation. We continue to use appendix as our first choice of continent catheterizable channel for antegrade continence enema procedures and in patients undergoing bladder procedures in whom the antegrade continence enema procedure is not planned. It has a reliable blood supply, ideal caliber and convenient anatomical location, as shown in a previous study.9 The pros and cons of each continent catheterizable channel type have been discussed previously.10 –12 We believe that forming a tension-free anastomosis with a straight and easily catheterizable segment that has a good blood supply is much more important than which continent catheterizable channel type is created. In an effort to quantify the effects of patient compliance on reconstructive outcome we divided patients into noncompliant and compliant groups. We arbitrarily defined our noncompliant and compliant groups because of the lack of known standardized comparison criteria. Patients could be more thoroughly stratified based on these and other parameters but our simplified method provides a useful starting point for evaluating the hypothesis that noncompliant patients have a poorer outcome. Although the importance of patient compliance in this situation may be inherently obvious, it was interesting to determine the quantitative effects of these factors on actual complication rates and prove what we already held to be a valid clinical axiom. Furthermore, this information may be useful for counseling patients about the negative impact of poor compliance on treatment outcome in the preoperative setting. The noncompliant group had the highest complication rate in each complication category. It was perhaps most striking for stomal stenosis, which developed in 56% of noncompliant patients compared with only 10% of compliant patients (p ⫽ 0.001). We advocate catheterization twice daily in patients who underwent the antegrade continence enema procedure and 4 to 6 times daily in those with a urinary continent catheterizable channel. It is clear from these data that adherence to these protocols helps to lower the rate of stomal stenosis. Infectious complications developed in a minority of patients. Nevertheless, they are a relatively common clinical entity. Most patients in this category had symptomatic cystitis and/or worrisome positive urine culture results with urease-splitting organisms such as Proteus, Pseudomonas and so forth. Less than 10% of the patients had associated fever or required hospital admission. Again the infection rate was significantly higher in the noncompliant group (63% versus 19%, p ⫽ 0.004). We speculate that by failing to catheterize regularly noncompliant patients had poor emptying, inadequate irrigation with excess mucous deposition and higher reservoir pressure with associated reflux. Each problem leads to increased infectious complications.

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Stone formation was an infrequent complication, occurring in only 4 patients (9%). However, this rate may have been partially attributable to our relatively short followup (average 22 months). Longer followup may reveal more patients with symptomatic stone disease.12, 13 Despite this limitation noncompliant patients had a much higher rate of stones that did not prove to be statistically significant, undoubtedly due to small numbers (19% versus 3%, p ⫽ 0.108). Again poor emptying and excess mucus in noncompliant patient most likely explains the difference in stone formation rates. We also assessed patient age to determine whether compliance status correlated with this variable. We noted a statistically significant difference of 8.2 years in the compliant versus 12.2 years noncompliant groups (p ⫽ 0.002). A hypothesis that may explain this result is that the younger patients received more vigorous supervision and parental support than the older patients. In addition, older patients who are entering adolescence often rebel against physician and parental direction. Furthermore, we evaluated age based percentile weight with the general hypothesis that more obese patients may have more tension on the anastomosis and, thus, a higher rate of stomal stenosis. Our results partially supported this thought, although not with statistical support. The greater than 100th percentile weight group had a stenosis rate of 40% versus 15% for the thinner patients in the 0 to 50th percentile group. Despite this fact the thinnest less than 0 percentile group also had a higher rate of stenosis (31%), which remains unexplained. One may argue that because abdominal thickness is relatively uniform in all individuals at the umbilicus, if the stoma is placed there, percentile weight should have no effect. However, if the subcutaneous tissue is released around the umbilicus better to visualize the skin for the anastomosis, the abdominal wall becomes as thick at the umbilicus as it is lateral. Perhaps factors such as nutritional status and family support had a role in the higher observed rate of stomal stenosis in the thinner children. CONCLUSIONS

The Mitrofanoff and antegrade continence enema procedures represent a reliable means of bladder and bowel reconstruction, and provide urinary and fecal continence in the majority of children with neurogenic bladder and bowel dysfunction. Proper patient selection is essential for achieving a satisfactory result. The type of material for continent catheterizable channel construction is not as important as the technical aspects of reconstruction. Patient compliance, age, the stomal skin incision and perhaps body habitus are also important variables that can quantitatively be used to predict the outcome in these patients. REFERENCES

1. Mitrofanoff, P.: Cystostomie continent trans-appendiculaire dans le traitement des vessies neurologiques. Chir Pediatr, 21: 297, 1980 2. Malone, P. S., Ransley, P. G. and Kiely, E. M.: Preliminary report: the antegrade continence enema. Lancet, 336: 1217, 1990 3. Yang, W. H.: Yang needle tunneling technique in creating antireflux and continent mechanisms. J Urol, 150: 830, 1993 4. Monti, P. R., Lara, R. C., Dutra, M. A. and deCarvalho, J. R.: New techniques for construction of efferent conduits based on the Mitrofanoff principle. Urology, 49: 112, 1997 5. Castellan, M. A., Gosalbez, R., Jr., Labbie, A. and Monti, P. R.: Clinical applications of the Monti procedure as a continent catheterizable stoma. Urology, 54: 152, 1999 6. Casale, A. J.: Continent vesicostomy: a new method utilizing only bladder tissue. Presented at 60th annual meeting of American Academy of Pediatrics, New Orleans, Louisiana, abstract 72, 1991 7. Liard, A., Sequier-Lipszyc, E., Mathiot, A. and Mitrofanoff, P.: The Mitrofanoff procedure: 20 years later. J Urol, 165: 2394, 2001

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8. Narayanaswamy, B., Wilcox, D. T., Cuckow, P. M., Duffy, P. G. and Ransley, P. G.: The Yang-Monti ileovesicostomy: a problematic channel? BJU Int, 87: 861, 2001 9. Duckett, J. W. and Lotfi, A. H.: Appendicovesicostomy (and variations) in bladder reconstruction. J Urol, 149: 567, 1993 10. Cain, M. P., Casale, A. J., King, S. J. and Rink, R. C.: Appendicovesicostomy and newer alternatives for the Mitrofanoff procedure: results in the last 100 patients at the Riley Children’s Hospital. J Urol, 162: 1749, 1999 11. Kaefer, M. and Retik, A. B.: The Mitrofanoff principle in continent urinary reconstruction. Urol Clin North Am, 24: 795, 1997 12. Kaefer, M., Tobin, M. S., Hendren, W. H., Bauer, S. B., Peters, C. A., Atala, A. et al: Continent urinary diversion: the Children’s Hospital experience. J Urol, 157: 1394, 1997 13. Suzer, O., Vates, T. S., Freedman, A. L., Smith, C. A. and Gonzalez, R.: Results of the Mitrofanoff procedure in urinary tract reconstruction in children. Br J Urol, 79: 279, 1997 EDITORIAL COMMENT The authors have made an important contribution to the field of reconstructive urological surgery for incontinence. While the data will not surprise many practitioners in the field, they serve to

reinforce and substantiate the belief that the best planned and executed surgeries are completely dependent on patient and family cooperation after the procedure. The authors provide an important analysis of how patient home care and compliance affect the complication rate in regard to stomal stenosis and infection, and present trends that indicate that the same correlation will eventually hold up in the area of stone formation. The tenet that the most difficult surgical decision is that which matches the patient to the operation could not be better illustrated than in surgery for incontinence in children. These results can be applied to all patients who undergo complex urinary reconstruction and, in particular, those who require intermittent catheterization. This article provides information that will help patients understand the level of commitment necessary to have success with this surgery and help surgeons decide which patients are good candidates for these procedures. Anthony J. Casale Department of Pediatric Urology Riley Children’s Hospital at Indiana University Indianapolis, Indiana