0022-534 7/92/1473-0582$03.00/0 Vol. 147, 582-586, March 1992
THE JOURNAL OF UROLOGY Copyright© 1992 by AMERICAN UROLOGICAL ASSOCIATION, INC.
Printed in U.S.A.
FUNCTIONAL EQUIVALENCE OF END AND LOOP ILEAL CONDUIT STOMAS GILBERTO CHECHILE, ERIC A. KLEIN,* LAURIE BAUER, ANDREW C. NOVICK JAMES E. MONTIE
AND
From the Department of Urology, Section of Urologic Oncology, Department of Biostatistics and Epidemiology, Cleveland Clinic Foundation, Cleveland, Ohio, and Department of Urology, Cleveland Clinic Florida, Fort Lauderdale, Florida
ABSTRACT
A total of 458 patients underwent ileal conduit urinary diversion between 1970 and 1984. An end stoma was constructed in 44% of the patients and a Turnbull loop stoma in 56%. The median interval between appliance changes for all patients was 5 days. Patients with an end stoma had a longer median interval between appliance changes than those with a loop stoma. A total of 51 patients had 66 complications. Operations for stomal revisions were required in 5.5% of the patients. There was no difference in interval until initial complication between the end and loop stoma groups, although the end stoma was more prone to ischemic complications than the loop stoma. We conclude that the ileal conduit stoma constructed in an end or loop fashion yielded clinically equivalent long-term function. KEY WORDS:
urinary diversion, ileum, ileostomy
The ileal conduit has been the standard form of urinary diversion since its description by Bricker. 1 Early reports centered on the adequacy of preservation of renal function during the short term in most patients and later many patients had complications related to the stoma. In many series stomal complications were the most frequently reported difficulties with the ileal conduit, with an incidence as high as 49%. 2 A growing awareness of these complications spawned the development of enterostomal therapy, and recognition of the need for patient education, preoperative stomal site selection and eversion of the stomal bud in obtaining an optimally functioning stoma. Coupled with improvements in external collecting devices these advances now routinely yield excellent stomal function in most patients. Until the mid 1970s ileal conduits generally were constructed with an end stomal configuration. Based on favorable experience with fecal diversion, Turnbull and Hewitt described the loop stoma for urinary diversion in 1978. 3 Use of the loop stoma was routinely adopted by some surgeons with excellent results. 4 Several comments in the literature attested to the superiority of the loop stoma even in the absence of reports that compared end and loop configurations in a concurrent series of patients. 5 • 6 We describe our experience with the ilea! conduit during a 15-year period with reference to the nature and frequency of complications of end and loop stomas. The results suggest that a properly constructed end or loop stoma yields comparable functional results and complication rates. MATERIALS AND METHODS
The charts of all patients undergoing cutaneous urinary diversion with an intestinal conduit at our clinic between January 1, 1970 and December 31, 1984 were reviewed. A total of 458 patients with an ilea! conduit was identified. There were 331 male and 127 female patients between 2 and 88 years old. Only 24 patients (5 %) were less than 18 years old at diversion. The most frequent indication for diversion was bladder cancer, with most patients undergoing concurrent radical cystectomy. Other indications included neurogenic bladder, incontinence, pelvic exenteration for gynecological or rectal malignancy, lower urinary tract obstruction, bladder exstrophy and various other conditions. Accepted for publication August 23, 1991. * Requests for reprints: Department of Urology, Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, Ohio 44195.
An end stoma was constructed in 203 patients (44 %) and a Turnbull loop stoma was constructed in 255 (56%). A total of 119 patients (26%) had undergone radiation therapy (mean dose 42 Gy.) before diversion. Followup ranged from 1 to 232 months. Of the patients 76% were followed for 1 year or longer (fig. 1). Although the use of an end stoma predominated in the early part of the series, median followup was identical for both groups (45 months) and followup between the groups was not statistically different (p >0.1, Wilcoxon rank sum test). Operative technique. Conduits were isolated from the distal ileum by standard techniques. Placement of the stoma was determined preoperatively for all patients by marking a suitable site with indelible ink after inspection of the abdominal wall with the patient in the supine, sitting and standing positions. Care was taken to ensure that the stoma was above the belt line, within easy sight by the patient, and removed from skin folds, scars and areas of retraction. Configuration as an end or loop stoma was determined by the preference of the surgeon. Although the patients of several different surgeons are included in this series, all followed the same general principles of stomal construction. A circular segment of skin, subcutaneous fat and anterior rectus fascia is excised at the previously selected stomal site (fig. 2, A). The fibers of the rectus muscle are bluntly split longitudinally, and the posterior rectus fascia, transversalis fascia and peritoneum are incised (fig. 2, A). For an end stoma the distal end of the conduit is grasped with a Babcock forceps and brought through the aperture in the abdominal wall (fig. 2, B). Several interrupted tripod sutures of 2-zero chromic are used to mature the stoma by incorporating the full thickness edge of the stoma, a seromuscular bite of conduit below the skin level and the subcuticular edge of the skin (fig. 2, C). For a loop stoma the distal end of the conduit is closed with sutures or staples. An umbilical tape is passed through a small mesenteric opening approximately 5 cm. more proximally and used to pull a knuckle of the conduit through the abdominal wall, keeping the distal end of the conduit cephalad (fig. 3, A). The umbilical tape is replaced with a plastic supporting rod, which is secured to the skin (fig. 3, B). The stoma is opened just above skin level across four-fifths of its cephalad circumference. Three tripod sutures are then placed in the caudad (functional) end of the stoma (fig. 3, B). The cephalad (defunctionalized) end of the stoma is then sutured subcuticularly to the skin. The stoma is intubated for 7 days with a 20F Foley catheter to
582
583
ILEAL CONDUI'I' STOMAS
NUMBER OF
ENTS
600~---------~----------~·-----~· 500 400 300 200 100 21 19 15 11
7
5
4
0 13 14 15 16 17 18 : 19 19 15 11
END LOOP
7
5
4
YEAR ~LOOP iBEND FIG. 1. Number of unfailed, uncensored patients at risk for complication by year of followup C
FIG. 2. A, creation of stomal aperture in abdominal wall. Circular segment of skin, subcutaneous fat and anterior rectus fascia is excised at previously selected stomal site. Fibers of rectus muscle are bluntly split longitudinally, and posterior rectus fascia, transversalis fascia and peritoneum are incised. B, creation of end stoma. Distal end of conduit is grasped with Babcock forceps and brought through aperture in abdominal wall. C, maturation of end stoma. Several interrupted tripod sutures of 2-zero chromic are used to create stomal bud by incorporating full thickness edge of stoma, seromuscular bite of conduit below skin level and subcuticular edge of skin. Final appearance of mature stoma is illustrated on right side. Reprinted with permission from Stewart, B.H.: Operative Urology. Baltimore: Williams & Wilkins, 1975.
A
B
FIG. 3. A, creation of loop stoma. Defunctionalized (distal) end of conduit is closed with sutures or staples. Umbilical tape is passed through small mesenteric opening approximately 5 cm. more proximally and used to pull knuckle of conduit through abdominal wall, keeping distal end of conduit cephalad. Reprinted with permission from Stewart, B. H.: Operative Urology. Baltimore: Williams & Wilkins, 1975. B, maturation of loop stoma. Umbilical tape is replaced with plastic supporting rod, which is secured to skin. Stoma is opened just above skin level across fourfifths of its cephalad circumference. Three tripod sutures as illustrated in figure 2, C are placed in caudad (functional) end of stoma. Cephalad (defunctionalized) end of stoma is sutured subcuticularly to skin. Final appearance of mature stoma is illustrated.
ensure decompression of the ileal loop while postoperative ileus resolves. Postoperative care. During the immediate postoperative period enterostomal therapists maintain and change appliances as necessary. On postoperative day 7 the stomal Foley catheter (and the supporting rod for loop stomas) is removed, and patients begin instruction in appliance care and management.
Patients are not discharged from the hospital until they have demonstrated proficiency in appliance care, usually requiring 3 lessons on successive days. Patients are instructed to change the appliance at least once a week. The patients are seen by the surgeon and enterostomal therapist at all postoperative visits. At the initial visit 4 to 6 weeks postoperatively the stoma is remeasured for fitting with
584
CHECHILE AND ASSOCIATES
a permanent appliance. During the initial and subsequent visits the appliance is removed, the stoma is inspected, and a 14F Foley catheter is passed into the conduit to test for patency, determine residual urine volume, and obtain a urine specimen for culture and cytology. The patient is then observed while reapplying the device. The size and condition of the stoma, condition of the peristomal skin, difficulties with the appliance, presence of parastomal hernia, and interval between appliance changes are assessed and recorded on the chart at each visit. Patient education or reinstruction was provided as necessary to treat identified problems. Definition of complications. Complications were defined as any stomal related problem that significantly interfered with the health of the patient or ability to maintain a comfortable life--style. This includedmedicalpwblems that required-hospitalization or more minor difficulties that interfered with normal appliance function. Stomal stenosis was defined as the inability to pass a 14F catheter through the stoma with residual urine volume of at least 25 cc. Stomal retraction was generally associated with stenosis and when the 2 occurred concurrently only stenosis was listed as a complication. Appliance difficulty included patients with allergies to vinyl and those with difficulty placing the appliance because of poor choice of stomal location or a poor stomal bud. Minor problems, such as folliculitis and dermatitis, that responded to conservative measures within 1 or 2 weeks of treatment, were not considered complications in this analysis. The remaining complications listed were generally self-evident by patient report or upon physical examination. Statistical methods. The Wilcoxon rank sum test was used to test differences in interval between appliance changes and length of followup. The probability of occurrence of an initial complication as a function of time was estimated by the Kaplan-Meier analysis. The Mantel-Haenszel log rank test was used to test for differences between these estimates. RESULTS
Interval between appliance changes. Data pertaining to interval between appliance changes were available for 331 patients (72%). The median interval between appliance changes for all patients was 5 days. Patients with an end stoma averaged a statistically significantly longer median interval between appliance changes (6 days) than those with loop stomas (5 days, p = 0.01, Wilcoxon rank sum test), although the range of appliance wear was similar for both groups (end stoma 1 to 10 days and loop stoma 2 to 10 days). Complications. A total of 51 patients suffered 66 complications (table 1). Of the 51 patients 40 had 1, 8 had 2, 2 had 3 and 1 had 4 complications. The risk of an initial complication developing as a function of time was not statistically significantly different between the end and loop stoma groups as estimated by Kaplan-Meier projections (p >0.2, log rank test, table 2 and fig. 4). The risk of a complication developing at 2, 5, 7 and 9 years for the end stoma group was 9, 15, 16 and 18%, TABLE 1.
Complications Stomal Configuration
Complication Parastomal hernia Appliance difficulty Stenosis Prolapse Ulceration Bleeding Retraction Dermatitis Ischemia Compression by abdominal wall tumor Totals
Loop (255 pts.)
Totals (458 pts.)
8 7 7 0 3 1 1 1 1 1
11 3 1 5 0 1 0 0 0 0
19
30
21
51
End (203 pts.)
10
8 5 3 2 1 1 1 1
TABLE 2.
Kaplan-Meier estimates of the probability of initial complication as a function of time Estimated Probability of Complication
Variable Yr. 2
Yr. 5
Yr. 7
Yr. 9
End stoma Loop stoma
0.09 0.06
0.15 0.11
0.16 0.13
0.18 0.17
Benign disease Malignancy
0.08 0.07
0.13 0.13
0.13 0.16
0.17 0.16
Previous radiation No radiation
0.04 0.08
0.13 0.13
0.13 0.15
0.13 0.17
Less than 18 yrs. old 18 or more yrs. old
0.13 0.07
0.19 0.13
0.19 0.14
0.19 0.17
respectively, and for the loop stoma group it was 6, 11, 13 and 17%, respectively (table 2). There were some differences in the type of complications affecting each group, with prolapse limited to the loop stoma patients and stenosis almost exclusively limited to those with an end stoma (table 1). Other complications affected both stomal types similarly. The risk of an initial complication developing as a function of time was not statistically significantly different between patients who underwent diversion for benign disease versus malignancy (p >0.5), patients with previous radiation therapy versus no radiotherapy (p >0.6) or patients less than 18 versus more than 18 years old (p >0.6, table 2). The type of complications also did not differ between these groups (data not shown). The complications occurring in the pediatric population (less than 18 years old) included 2 patients with stenosis, 2 with appliance difficulty, 1 with retraction and 1 with compression by an abdominal wall tumor. The small number of patients with multiple complications (8 with an end stoma and 3 with a loop stoma) prevented meaningful statistical comparison between stomal types for this parameter. Revisions. A total of 25 patients required 41 operations for stomal revisions, for an overall revision rate of 5.5%. Of the 25 patients 17 required 1, 3 required 2, 3 required 3, 1 required 4 and 1 required 5 revisions. Revisions were required for 17 of 203 end stomas (8.4%) and 8 of 255 loop stomas (3.1%). The indication for revision paralleled the type of complications and did not otherwise differ between the stomal types (table 3). DISCUSSION
Several years ago we reported on a series of patients undergoing urinary diversion with cutaneous conduits of large or small bowel during a 10-year period. 7 We demonstrated that the rate of stomal complications (8.5%) and the need for surgical revision (5%) were low after this type of diversion. We also found that end or loop stomas yielded equivalent function as measured by the average interval between appliance changes, complication rates and revision rates. One limitation of that study was that most of the end stomas were performed early in the series so that the mean followup for patients with an end stoma was significantly longer than that for those with a loop stoma. This left open the possibility that longer followup would identify a higher complication rate in loop stoma patients. To address this issue we followed these patients for an additional 5 years and expanded the study population through 1984 to include an additional 139 patients. We also used a statistical strategy that estimates the risk of complication as a function of time to control for differences in length of followup. Because the number of patients with a colon or jejunal conduit during the study interval was small (20), we limited analysis to those undergoing ileal conduit diversion. Our results are similar to those of the earlier study with comparable complication rates and need for revision (5. 7 versus 5.5%). We found on the average that patients were able to wear the appliance without leakage for a median of 5 days. Patients
585
ILE.AL CONDUIT STOMAS
Tirne until Stomal Complication lleai Conduits 0.9 0.8
0.7
.-E' :.acu
0.6
e 0...
0.4~
..0
0.5
I
0.3] 0.2: 0.1 0 0
,----------------~------,2
4
6
8
10
12
14
16
18
20
Years
FEnd ~ Loop
I
FIG. 4. Probability of occurrence of initial complication as function of time for end and loop stomas as estimated by Kaplan-Meier analysis
TABLE
3. Stomal revisions Stomal Configuration
Indication for Revision Parastomal hernia Stenosis Poor location Prolapse Retraction Desmoid tumor Parastomal fistula Totals
End (203 pts.) 11 8
Loop (255 pts.)
0 1 2 2
6 3 0 2 2 0 0
28
13
4
Totals (458 pts.) 17 11 4 2 3 2 2
:rr
Discrepancies in the total column compared with table 1 are accounted for by multiple revisions for a single complication in some patients.
with an end stoma had a statistically significantly longer median interval between appliance changes than those with a loop stoma (6 versus 5 days). The practical significance of this finding is less, since both groups had a similar range of appliance wear (up to 10 days) and the difference of 1 day translates to l extra appliance change per month during the course of 1 year. The risk of an initial complication developing as a function of time did not differ between the end stoma and loop stoma groups when estimated by Kaplan-Meier time-to-event analysis. The risk of a complication developing increased with time from 6 to 9% at 2 years to 18% at 9 years. The small number of each individual complication makes statistical comparison for each complication meaningless between the end and loop stoma groups. However, there are some differences in the type of complications that affect each group. Ischemic complications, such as stenosis, ulceration, retraction and true ischemia, were generally limited to end stoma patients. This may result from the tendency of an end stoma to have more tension than a loop stoma on the mesentery as it traverses the abdominal wall. Perhaps the only clear advantage to the loop stoma is that it is easier to obtain a good stomal bud above skin level without tension on the mesentery than with an end stoma, especially in the obese patient. The problem of prolapse was limited to the loop stoma. In all cases this included prolapse of the defunctionalized end of the stoma, and was easily repaired by simple excision and refixation of the functional end to the skin. Other complications, including the most frequently occurring
complication of parastomal hernia, did not appear to have a predilection for either stomal type. The nature and frequency of complications in this series compare favorably to those reported by others. Bloom et al reported a 16% complication rate in 100 consecutive loop stomas, with 14 parastomal hernias (compared to 4 % in our series) and 2 stomas with prolapse of the defunctionalized end. 4 They reported no instance of stomal stenosis. Emmott et al reported a 44 % rate of stomal stenosis in 27 end stomas compared with none in 54 loop stomas. 8 They observed that most of the stenotic stomas showed signs of ischemia during the immediate postoperative period, although they did not specify how long these stomas were functional. We generally observed stomal stenosis to be a late complication, typically more than 24 months postoperatively. Emmott et al also reported a higher rate of retraction (roughly 10% for both stomal types) than we encounter~d. The reason for this discrepancy is not clear, since their described technique is similar to our own. They also reported a rate of parastomal hernia (3%) closer to our own. We have not found it necessary to close the fascia on the peritoneal side of the abdominal wall as described by Bloom et al to prevent hernias. 4 Both studies reported rare instances of stomal incrustation and dermatitis, and suggested that this is an advantage of the loop stoma. These problems were similarly rare in our experience in either the end or loop stoma group, and we believe that their infrequent occurrence is due to careful attention to appliance fit and good skin care rather than a function of the stomal type. We considered several other factors as potential predictors of stomal complications, including reason for diversion (benign disease versus malignancy), previous pelvic irradiation and patient age (less than 18 versus more than 18 years old) at diversion. Statistical analysis revealed no differences in the risk of a complication between these groups. Because they were the most frequent complications parastomal hernia and stomal stenosis were the most frequent indications for revision. The need for revision in some patients arose from conditions not directly related to stomal construction (table 3). One patient required 2 revisions because of parastomal enterocutaneous fistulas and another because of desmoid tumor involving the stoma. Although in most instances only a single revision was required, 8 patients (30% of those requiring revision) required multiple operations, emphasizing
586
CHECHILE AND ASSOCIATES
the importance of obtaining a good result with initial stomal construction. The number of revisions required for the end stoma group was more than double that for the loop stoma group (8.4 versus 3.1%). This finding most likely represents differences in the nature of the complications affecting each stomal type. Most of the complications encountered in the end stoma group were ischemic and more often resulted in significant problems with appliance wear or patient health. These complications not only required more revisions to repair but they generally required operations of larger magnitude (such as reconstruction of an entire conduit) than for the loop stoma. Potential limitations in the interpretation of these data are unrecognized patient selection factors for which we could not control, including patient characteristics, such as obesity or mesenterie at-herosele-resis-, 0r those w-it-h sh0rtmesenter-ies-wh-0 in the judgment of the surgeon were better served with a loop rather than an end stoma. The fact that prior radiotherapy did not increase the risk of complication reflects our attempt to avoid the use of intestinal segments that had obvious radiation damage. Since this was not a randomized trial, the role of these selection factors in choosing the end or loop stoma is not assessable. We believe that in a thin patient who has no factors that predispose to vascular compromise either an end or loop stoma will yield satisfactory long-term function. However, in the obese patient or those in whom the potential for vascular compromise may exist a loop stoma may offer the best chance of a satisfactory outcome. We previously emphasized the factors that we consider important to obtain optimal stomal, function. 7 These factors include careful preoperative site selection, creation of an everted stomal bud without tension on the mesentery, preoperative and postoperative patient education, and meticulous postoperative skin care. These considerations apply equally to the care and construction of either an end or loop stoma. Our results suggest some variability in the type of complications that afflict individual stomal types. Nonetheless, the results also suggest that when these criteria are met an end or loop ileal conduit stoma yields equivalent long-term results. REFERENCES
1. Bricker, E. M.: Bladder substitution after pelvic evisceration. Surg.
Clin. N. Amer., 30: 1511, 1950.
2. Dunn, M., Roberts, J. B. M., Smith, P. J. B. and Slade, N.: The long-term results of ileal conduit urinary diversion in children. Brit. J. Urol., 51: 458, 1979. 3. Turnbull, R. B., Jr. and Hewitt, C. R.: Loop-end myotomy ileostomy in the obese patient. Urol. Clin. N. Amer., 5: 423, 1978. 4. Bloom, D. A., Lieskovsky, G., Rainwater, G. and Skinner, D. G.: The Turnbull loop stoma. J. Urol., 129: 715, 1983. 5. Hendren, W. H.: Editorial comment. J. Urol., 129: 718, 1983. 6. Hampel, N., Bodner, D.R. and Persky, L.: Heal andjejunal conduit urinary diversion. Urol. Clin. N. Amer., 13: 207, 1986. 7. Klein, E. A., Montie, J. E., Montague, D. K., Novick, A. C. and Straffon, R. A.: Stomal complications of intestinal conduit urinary diversion. Cleveland Clin. J. Med., 56: 48, 1989. 8. Emmott, D., Noble, M. J. and Mebust, W. K.: A comparison of end versus loop stomas for ileal conduit urinary diversion. J. Urol., 133: 588, 1985.
EDITORIAL COMMENT A wide range of indications coupled with the lack of an ideal substitute for the normal bladder promises to keep urinary diversion a subject for continuing investigation and an important procedure in the surgical armamentarium. Although quality of life issues have helped to stimulate the evolution of techniques that obviate the need for an external appliance, either by creation of a continent abdominal stoma permitting intermittent catheterization or of an intestinal reservoir anastomosed to the urethra above a functional sphincter, it seems doubtful that the indications for the incontinent abdominal stoma of an intestinal urinary conduit will disappear completely from the surgical armamentarium within the foreseeable future. The relative merits of the end versus the loop stoma techniques in the latter situation continue to be debated and the large Cleveland Clinic experience reported by the authors is pertinent to this issue. Although the precise circumstances leading to the selection of 1 technique over the other could not be rigorously documented, the fact is that each technique generally served well. Ischemic complications were limited to end stomas, whereas prolapse was limited to loop stomas. This suggests that in the thin patient without predisposition to vascular compromise, either technique will work well, whereas obesity and vascular compromise provide relative indications for a loop stoma. Good judgment in selection of method, careful technical performance, and meticulous postoperative management and followup provide the basis for the longterm functional equivalence of the 2 techniques. Willet F. Whitmore, Jr. Urology Department Memorial Hospital New York, New York
THE JOURNAL OF UROLOGY Copyright© 1992 by AMERICAN UROLOGICAL ASSOCIATION, INC.
Printed in U.S.A.
FUNCTIONAL EQUIVALENCE OF END AND LOOP ILEAL CONDUIT STOMAS GILBERTO CHECHILE, ERIC A. KLEIN,* LAURIE BAUER, ANDREW C. NOVICK JAMES E. MONTIE
AND
From the Department of Urology, Section of Urologic Oncology, Department of Biostatistics and Epidemiology, Cleveland Clinic Foundation, Cleveland, Ohio, and Department of Urology, Cleveland Clinic Florida, Fort Lauderdale, Florida
ABSTRACT
A total of 458 patients underwent ileal conduit urinary diversion between 1970 and 1984. An end stoma was constructed in 44% of the patients and a Turnbull loop stoma in 56%. The median interval between appliance changes for all patients was 5 days. Patients with an end stoma had a longer median interval between appliance changes than those with a loop stoma. A total of 51 patients had 66 complications. Operations for stomal revisions were required in 5.5% of the patients. There was no difference in interval until initial complication between the end and loop stoma groups, although the end stoma was more prone to ischemic complications than the loop stoma. We conclude that the ileal conduit stoma constructed in an end or loop fashion yielded clinically equivalent long-term function. KEY WORDS:
urinary diversion, ileum, ileostomy
The ileal conduit has been the standard form of urinary diversion since its description by Bricker. 1 Early reports centered on the adequacy of preservation of renal function during the short term in most patients and later many patients had complications related to the stoma. In many series stomal complications were the most frequently reported difficulties with the ileal conduit, with an incidence as high as 49%. 2 A growing awareness of these complications spawned the development of enterostomal therapy, and recognition of the need for patient education, preoperative stomal site selection and eversion of the stomal bud in obtaining an optimally functioning stoma. Coupled with improvements in external collecting devices these advances now routinely yield excellent stomal function in most patients. Until the mid 1970s ileal conduits generally were constructed with an end stomal configuration. Based on favorable experience with fecal diversion, Turnbull and Hewitt described the loop stoma for urinary diversion in 1978. 3 Use of the loop stoma was routinely adopted by some surgeons with excellent results. 4 Several comments in the literature attested to the superiority of the loop stoma even in the absence of reports that compared end and loop configurations in a concurrent series of patients. 5 • 6 We describe our experience with the ilea! conduit during a 15-year period with reference to the nature and frequency of complications of end and loop stomas. The results suggest that a properly constructed end or loop stoma yields comparable functional results and complication rates. MATERIALS AND METHODS
The charts of all patients undergoing cutaneous urinary diversion with an intestinal conduit at our clinic between January 1, 1970 and December 31, 1984 were reviewed. A total of 458 patients with an ilea! conduit was identified. There were 331 male and 127 female patients between 2 and 88 years old. Only 24 patients (5 %) were less than 18 years old at diversion. The most frequent indication for diversion was bladder cancer, with most patients undergoing concurrent radical cystectomy. Other indications included neurogenic bladder, incontinence, pelvic exenteration for gynecological or rectal malignancy, lower urinary tract obstruction, bladder exstrophy and various other conditions. Accepted for publication August 23, 1991. * Requests for reprints: Department of Urology, Cleveland Clinic Foundation, 9500 Euclid Ave., Cleveland, Ohio 44195.
An end stoma was constructed in 203 patients (44 %) and a Turnbull loop stoma was constructed in 255 (56%). A total of 119 patients (26%) had undergone radiation therapy (mean dose 42 Gy.) before diversion. Followup ranged from 1 to 232 months. Of the patients 76% were followed for 1 year or longer (fig. 1). Although the use of an end stoma predominated in the early part of the series, median followup was identical for both groups (45 months) and followup between the groups was not statistically different (p >0.1, Wilcoxon rank sum test). Operative technique. Conduits were isolated from the distal ileum by standard techniques. Placement of the stoma was determined preoperatively for all patients by marking a suitable site with indelible ink after inspection of the abdominal wall with the patient in the supine, sitting and standing positions. Care was taken to ensure that the stoma was above the belt line, within easy sight by the patient, and removed from skin folds, scars and areas of retraction. Configuration as an end or loop stoma was determined by the preference of the surgeon. Although the patients of several different surgeons are included in this series, all followed the same general principles of stomal construction. A circular segment of skin, subcutaneous fat and anterior rectus fascia is excised at the previously selected stomal site (fig. 2, A). The fibers of the rectus muscle are bluntly split longitudinally, and the posterior rectus fascia, transversalis fascia and peritoneum are incised (fig. 2, A). For an end stoma the distal end of the conduit is grasped with a Babcock forceps and brought through the aperture in the abdominal wall (fig. 2, B). Several interrupted tripod sutures of 2-zero chromic are used to mature the stoma by incorporating the full thickness edge of the stoma, a seromuscular bite of conduit below the skin level and the subcuticular edge of the skin (fig. 2, C). For a loop stoma the distal end of the conduit is closed with sutures or staples. An umbilical tape is passed through a small mesenteric opening approximately 5 cm. more proximally and used to pull a knuckle of the conduit through the abdominal wall, keeping the distal end of the conduit cephalad (fig. 3, A). The umbilical tape is replaced with a plastic supporting rod, which is secured to the skin (fig. 3, B). The stoma is opened just above skin level across four-fifths of its cephalad circumference. Three tripod sutures are then placed in the caudad (functional) end of the stoma (fig. 3, B). The cephalad (defunctionalized) end of the stoma is then sutured subcuticularly to the skin. The stoma is intubated for 7 days with a 20F Foley catheter to
582
583
ILEAL CONDUI'I' STOMAS
NUMBER OF
ENTS
600~---------~----------~·-----~· 500 400 300 200 100 21 19 15 11
7
5
4
0 13 14 15 16 17 18 : 19 19 15 11
END LOOP
7
5
4
YEAR ~LOOP iBEND FIG. 1. Number of unfailed, uncensored patients at risk for complication by year of followup C
FIG. 2. A, creation of stomal aperture in abdominal wall. Circular segment of skin, subcutaneous fat and anterior rectus fascia is excised at previously selected stomal site. Fibers of rectus muscle are bluntly split longitudinally, and posterior rectus fascia, transversalis fascia and peritoneum are incised. B, creation of end stoma. Distal end of conduit is grasped with Babcock forceps and brought through aperture in abdominal wall. C, maturation of end stoma. Several interrupted tripod sutures of 2-zero chromic are used to create stomal bud by incorporating full thickness edge of stoma, seromuscular bite of conduit below skin level and subcuticular edge of skin. Final appearance of mature stoma is illustrated on right side. Reprinted with permission from Stewart, B.H.: Operative Urology. Baltimore: Williams & Wilkins, 1975.
A
B
FIG. 3. A, creation of loop stoma. Defunctionalized (distal) end of conduit is closed with sutures or staples. Umbilical tape is passed through small mesenteric opening approximately 5 cm. more proximally and used to pull knuckle of conduit through abdominal wall, keeping distal end of conduit cephalad. Reprinted with permission from Stewart, B. H.: Operative Urology. Baltimore: Williams & Wilkins, 1975. B, maturation of loop stoma. Umbilical tape is replaced with plastic supporting rod, which is secured to skin. Stoma is opened just above skin level across fourfifths of its cephalad circumference. Three tripod sutures as illustrated in figure 2, C are placed in caudad (functional) end of stoma. Cephalad (defunctionalized) end of stoma is sutured subcuticularly to skin. Final appearance of mature stoma is illustrated.
ensure decompression of the ileal loop while postoperative ileus resolves. Postoperative care. During the immediate postoperative period enterostomal therapists maintain and change appliances as necessary. On postoperative day 7 the stomal Foley catheter (and the supporting rod for loop stomas) is removed, and patients begin instruction in appliance care and management.
Patients are not discharged from the hospital until they have demonstrated proficiency in appliance care, usually requiring 3 lessons on successive days. Patients are instructed to change the appliance at least once a week. The patients are seen by the surgeon and enterostomal therapist at all postoperative visits. At the initial visit 4 to 6 weeks postoperatively the stoma is remeasured for fitting with
584
CHECHILE AND ASSOCIATES
a permanent appliance. During the initial and subsequent visits the appliance is removed, the stoma is inspected, and a 14F Foley catheter is passed into the conduit to test for patency, determine residual urine volume, and obtain a urine specimen for culture and cytology. The patient is then observed while reapplying the device. The size and condition of the stoma, condition of the peristomal skin, difficulties with the appliance, presence of parastomal hernia, and interval between appliance changes are assessed and recorded on the chart at each visit. Patient education or reinstruction was provided as necessary to treat identified problems. Definition of complications. Complications were defined as any stomal related problem that significantly interfered with the health of the patient or ability to maintain a comfortable life--style. This includedmedicalpwblems that required-hospitalization or more minor difficulties that interfered with normal appliance function. Stomal stenosis was defined as the inability to pass a 14F catheter through the stoma with residual urine volume of at least 25 cc. Stomal retraction was generally associated with stenosis and when the 2 occurred concurrently only stenosis was listed as a complication. Appliance difficulty included patients with allergies to vinyl and those with difficulty placing the appliance because of poor choice of stomal location or a poor stomal bud. Minor problems, such as folliculitis and dermatitis, that responded to conservative measures within 1 or 2 weeks of treatment, were not considered complications in this analysis. The remaining complications listed were generally self-evident by patient report or upon physical examination. Statistical methods. The Wilcoxon rank sum test was used to test differences in interval between appliance changes and length of followup. The probability of occurrence of an initial complication as a function of time was estimated by the Kaplan-Meier analysis. The Mantel-Haenszel log rank test was used to test for differences between these estimates. RESULTS
Interval between appliance changes. Data pertaining to interval between appliance changes were available for 331 patients (72%). The median interval between appliance changes for all patients was 5 days. Patients with an end stoma averaged a statistically significantly longer median interval between appliance changes (6 days) than those with loop stomas (5 days, p = 0.01, Wilcoxon rank sum test), although the range of appliance wear was similar for both groups (end stoma 1 to 10 days and loop stoma 2 to 10 days). Complications. A total of 51 patients suffered 66 complications (table 1). Of the 51 patients 40 had 1, 8 had 2, 2 had 3 and 1 had 4 complications. The risk of an initial complication developing as a function of time was not statistically significantly different between the end and loop stoma groups as estimated by Kaplan-Meier projections (p >0.2, log rank test, table 2 and fig. 4). The risk of a complication developing at 2, 5, 7 and 9 years for the end stoma group was 9, 15, 16 and 18%, TABLE 1.
Complications Stomal Configuration
Complication Parastomal hernia Appliance difficulty Stenosis Prolapse Ulceration Bleeding Retraction Dermatitis Ischemia Compression by abdominal wall tumor Totals
Loop (255 pts.)
Totals (458 pts.)
8 7 7 0 3 1 1 1 1 1
11 3 1 5 0 1 0 0 0 0
19
30
21
51
End (203 pts.)
10
8 5 3 2 1 1 1 1
TABLE 2.
Kaplan-Meier estimates of the probability of initial complication as a function of time Estimated Probability of Complication
Variable Yr. 2
Yr. 5
Yr. 7
Yr. 9
End stoma Loop stoma
0.09 0.06
0.15 0.11
0.16 0.13
0.18 0.17
Benign disease Malignancy
0.08 0.07
0.13 0.13
0.13 0.16
0.17 0.16
Previous radiation No radiation
0.04 0.08
0.13 0.13
0.13 0.15
0.13 0.17
Less than 18 yrs. old 18 or more yrs. old
0.13 0.07
0.19 0.13
0.19 0.14
0.19 0.17
respectively, and for the loop stoma group it was 6, 11, 13 and 17%, respectively (table 2). There were some differences in the type of complications affecting each group, with prolapse limited to the loop stoma patients and stenosis almost exclusively limited to those with an end stoma (table 1). Other complications affected both stomal types similarly. The risk of an initial complication developing as a function of time was not statistically significantly different between patients who underwent diversion for benign disease versus malignancy (p >0.5), patients with previous radiation therapy versus no radiotherapy (p >0.6) or patients less than 18 versus more than 18 years old (p >0.6, table 2). The type of complications also did not differ between these groups (data not shown). The complications occurring in the pediatric population (less than 18 years old) included 2 patients with stenosis, 2 with appliance difficulty, 1 with retraction and 1 with compression by an abdominal wall tumor. The small number of patients with multiple complications (8 with an end stoma and 3 with a loop stoma) prevented meaningful statistical comparison between stomal types for this parameter. Revisions. A total of 25 patients required 41 operations for stomal revisions, for an overall revision rate of 5.5%. Of the 25 patients 17 required 1, 3 required 2, 3 required 3, 1 required 4 and 1 required 5 revisions. Revisions were required for 17 of 203 end stomas (8.4%) and 8 of 255 loop stomas (3.1%). The indication for revision paralleled the type of complications and did not otherwise differ between the stomal types (table 3). DISCUSSION
Several years ago we reported on a series of patients undergoing urinary diversion with cutaneous conduits of large or small bowel during a 10-year period. 7 We demonstrated that the rate of stomal complications (8.5%) and the need for surgical revision (5%) were low after this type of diversion. We also found that end or loop stomas yielded equivalent function as measured by the average interval between appliance changes, complication rates and revision rates. One limitation of that study was that most of the end stomas were performed early in the series so that the mean followup for patients with an end stoma was significantly longer than that for those with a loop stoma. This left open the possibility that longer followup would identify a higher complication rate in loop stoma patients. To address this issue we followed these patients for an additional 5 years and expanded the study population through 1984 to include an additional 139 patients. We also used a statistical strategy that estimates the risk of complication as a function of time to control for differences in length of followup. Because the number of patients with a colon or jejunal conduit during the study interval was small (20), we limited analysis to those undergoing ileal conduit diversion. Our results are similar to those of the earlier study with comparable complication rates and need for revision (5. 7 versus 5.5%). We found on the average that patients were able to wear the appliance without leakage for a median of 5 days. Patients
585
ILE.AL CONDUIT STOMAS
Tirne until Stomal Complication lleai Conduits 0.9 0.8
0.7
.-E' :.acu
0.6
e 0...
0.4~
..0
0.5
I
0.3] 0.2: 0.1 0 0
,----------------~------,2
4
6
8
10
12
14
16
18
20
Years
FEnd ~ Loop
I
FIG. 4. Probability of occurrence of initial complication as function of time for end and loop stomas as estimated by Kaplan-Meier analysis
TABLE
3. Stomal revisions Stomal Configuration
Indication for Revision Parastomal hernia Stenosis Poor location Prolapse Retraction Desmoid tumor Parastomal fistula Totals
End (203 pts.) 11 8
Loop (255 pts.)
0 1 2 2
6 3 0 2 2 0 0
28
13
4
Totals (458 pts.) 17 11 4 2 3 2 2
:rr
Discrepancies in the total column compared with table 1 are accounted for by multiple revisions for a single complication in some patients.
with an end stoma had a statistically significantly longer median interval between appliance changes than those with a loop stoma (6 versus 5 days). The practical significance of this finding is less, since both groups had a similar range of appliance wear (up to 10 days) and the difference of 1 day translates to l extra appliance change per month during the course of 1 year. The risk of an initial complication developing as a function of time did not differ between the end stoma and loop stoma groups when estimated by Kaplan-Meier time-to-event analysis. The risk of a complication developing increased with time from 6 to 9% at 2 years to 18% at 9 years. The small number of each individual complication makes statistical comparison for each complication meaningless between the end and loop stoma groups. However, there are some differences in the type of complications that affect each group. Ischemic complications, such as stenosis, ulceration, retraction and true ischemia, were generally limited to end stoma patients. This may result from the tendency of an end stoma to have more tension than a loop stoma on the mesentery as it traverses the abdominal wall. Perhaps the only clear advantage to the loop stoma is that it is easier to obtain a good stomal bud above skin level without tension on the mesentery than with an end stoma, especially in the obese patient. The problem of prolapse was limited to the loop stoma. In all cases this included prolapse of the defunctionalized end of the stoma, and was easily repaired by simple excision and refixation of the functional end to the skin. Other complications, including the most frequently occurring
complication of parastomal hernia, did not appear to have a predilection for either stomal type. The nature and frequency of complications in this series compare favorably to those reported by others. Bloom et al reported a 16% complication rate in 100 consecutive loop stomas, with 14 parastomal hernias (compared to 4 % in our series) and 2 stomas with prolapse of the defunctionalized end. 4 They reported no instance of stomal stenosis. Emmott et al reported a 44 % rate of stomal stenosis in 27 end stomas compared with none in 54 loop stomas. 8 They observed that most of the stenotic stomas showed signs of ischemia during the immediate postoperative period, although they did not specify how long these stomas were functional. We generally observed stomal stenosis to be a late complication, typically more than 24 months postoperatively. Emmott et al also reported a higher rate of retraction (roughly 10% for both stomal types) than we encounter~d. The reason for this discrepancy is not clear, since their described technique is similar to our own. They also reported a rate of parastomal hernia (3%) closer to our own. We have not found it necessary to close the fascia on the peritoneal side of the abdominal wall as described by Bloom et al to prevent hernias. 4 Both studies reported rare instances of stomal incrustation and dermatitis, and suggested that this is an advantage of the loop stoma. These problems were similarly rare in our experience in either the end or loop stoma group, and we believe that their infrequent occurrence is due to careful attention to appliance fit and good skin care rather than a function of the stomal type. We considered several other factors as potential predictors of stomal complications, including reason for diversion (benign disease versus malignancy), previous pelvic irradiation and patient age (less than 18 versus more than 18 years old) at diversion. Statistical analysis revealed no differences in the risk of a complication between these groups. Because they were the most frequent complications parastomal hernia and stomal stenosis were the most frequent indications for revision. The need for revision in some patients arose from conditions not directly related to stomal construction (table 3). One patient required 2 revisions because of parastomal enterocutaneous fistulas and another because of desmoid tumor involving the stoma. Although in most instances only a single revision was required, 8 patients (30% of those requiring revision) required multiple operations, emphasizing
586
CHECHILE AND ASSOCIATES
the importance of obtaining a good result with initial stomal construction. The number of revisions required for the end stoma group was more than double that for the loop stoma group (8.4 versus 3.1%). This finding most likely represents differences in the nature of the complications affecting each stomal type. Most of the complications encountered in the end stoma group were ischemic and more often resulted in significant problems with appliance wear or patient health. These complications not only required more revisions to repair but they generally required operations of larger magnitude (such as reconstruction of an entire conduit) than for the loop stoma. Potential limitations in the interpretation of these data are unrecognized patient selection factors for which we could not control, including patient characteristics, such as obesity or mesenterie at-herosele-resis-, 0r those w-it-h sh0rtmesenter-ies-wh-0 in the judgment of the surgeon were better served with a loop rather than an end stoma. The fact that prior radiotherapy did not increase the risk of complication reflects our attempt to avoid the use of intestinal segments that had obvious radiation damage. Since this was not a randomized trial, the role of these selection factors in choosing the end or loop stoma is not assessable. We believe that in a thin patient who has no factors that predispose to vascular compromise either an end or loop stoma will yield satisfactory long-term function. However, in the obese patient or those in whom the potential for vascular compromise may exist a loop stoma may offer the best chance of a satisfactory outcome. We previously emphasized the factors that we consider important to obtain optimal stomal, function. 7 These factors include careful preoperative site selection, creation of an everted stomal bud without tension on the mesentery, preoperative and postoperative patient education, and meticulous postoperative skin care. These considerations apply equally to the care and construction of either an end or loop stoma. Our results suggest some variability in the type of complications that afflict individual stomal types. Nonetheless, the results also suggest that when these criteria are met an end or loop ileal conduit stoma yields equivalent long-term results. REFERENCES
1. Bricker, E. M.: Bladder substitution after pelvic evisceration. Surg.
Clin. N. Amer., 30: 1511, 1950.
2. Dunn, M., Roberts, J. B. M., Smith, P. J. B. and Slade, N.: The long-term results of ileal conduit urinary diversion in children. Brit. J. Urol., 51: 458, 1979. 3. Turnbull, R. B., Jr. and Hewitt, C. R.: Loop-end myotomy ileostomy in the obese patient. Urol. Clin. N. Amer., 5: 423, 1978. 4. Bloom, D. A., Lieskovsky, G., Rainwater, G. and Skinner, D. G.: The Turnbull loop stoma. J. Urol., 129: 715, 1983. 5. Hendren, W. H.: Editorial comment. J. Urol., 129: 718, 1983. 6. Hampel, N., Bodner, D.R. and Persky, L.: Heal andjejunal conduit urinary diversion. Urol. Clin. N. Amer., 13: 207, 1986. 7. Klein, E. A., Montie, J. E., Montague, D. K., Novick, A. C. and Straffon, R. A.: Stomal complications of intestinal conduit urinary diversion. Cleveland Clin. J. Med., 56: 48, 1989. 8. Emmott, D., Noble, M. J. and Mebust, W. K.: A comparison of end versus loop stomas for ileal conduit urinary diversion. J. Urol., 133: 588, 1985.
EDITORIAL COMMENT A wide range of indications coupled with the lack of an ideal substitute for the normal bladder promises to keep urinary diversion a subject for continuing investigation and an important procedure in the surgical armamentarium. Although quality of life issues have helped to stimulate the evolution of techniques that obviate the need for an external appliance, either by creation of a continent abdominal stoma permitting intermittent catheterization or of an intestinal reservoir anastomosed to the urethra above a functional sphincter, it seems doubtful that the indications for the incontinent abdominal stoma of an intestinal urinary conduit will disappear completely from the surgical armamentarium within the foreseeable future. The relative merits of the end versus the loop stoma techniques in the latter situation continue to be debated and the large Cleveland Clinic experience reported by the authors is pertinent to this issue. Although the precise circumstances leading to the selection of 1 technique over the other could not be rigorously documented, the fact is that each technique generally served well. Ischemic complications were limited to end stomas, whereas prolapse was limited to loop stomas. This suggests that in the thin patient without predisposition to vascular compromise, either technique will work well, whereas obesity and vascular compromise provide relative indications for a loop stoma. Good judgment in selection of method, careful technical performance, and meticulous postoperative management and followup provide the basis for the longterm functional equivalence of the 2 techniques. Willet F. Whitmore, Jr. Urology Department Memorial Hospital New York, New York
