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Ureteroileocecal Appendicostomy Based Urinary Reservoir in Irradiated and Nonirradiated Patients
Ureteroileocecal Appendicostomy Based Urinary Reservoir in Irradiated and Nonirradiated Patients Bernard H. Bochner,* Nick Karanikolas, Richard R. Barakat, Douglas Wong† and Dennis S. Chi From the Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York
Abbreviations and Acronyms CCR ⫽ continent cutaneous reservoir UIA ⫽ ureteroileocecal appendicostomy Submitted for publication March 14, 2009. Study received institutional review board approval. Supported by an Allbritton Foundation grant. * Correspondence: Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, Kimmel Center for Prostate and Urologic Cancers, 353 East 68th St., New York, New York 10021 (telephone: 646-422-4387; FAX: 212988-0759; e-mail: [email protected]). † Financial interest and/or other relationship with PowerMed Interventions and BK Medical Systems.
Purpose: The ureteroileocecal appendicostomy reservoir is designed to potentially decrease the morbidity of continent diversion, particularly in previously irradiated patients. We report our experience with this reservoir to compare complications in irradiated and nonirradiated patients. Materials and Methods: The records of 52 consecutive patients who underwent ureteroileocecal appendicostomy diversion between March 2001 and January 2008 were evaluated. Outcomes were analyzed according to whether patients received radiation therapy to the pelvis. Complications were reported as early (within 90 days of surgery) or late. Results: Overall 29 patients received radiation therapy. The incidence of early complications requiring operative intervention was 14%, including 2 patients (9%) with and 5 (17%) without radiation (p ⫽ 0.68). All except 1 reoperation was done to revise the stoma. Early urinary tract infections developed in 17% of nonirradiated and 28% of irradiated patients (p ⫽ 0.51). The most common late complication was stomal stenosis requiring dilation on an outpatient basis, which occurred in 21% of patients, including 4 with (17%) and 7 without (24%) radiation (p ⫽ 0.74). Late ureteral complications requiring intervention were reported in 15% of renal units, including 2 of 44 without (5%) and 6 of 56 with (11%) radiation (p ⫽ 0.21). Conclusions: Ureteroileocecal appendicostomy is a safe, effective technique for continent cutaneous urinary diversion in heavily irradiated patients. Complication rates did not significantly differ between irradiated and nonirradiated patients, and appear improved compared to those in previous reports. Key Words: urinary bladder, cystectomy, urinary diversion, urogenital neoplasms, radiotherapy
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ADVANCES in urinary tract reconstruction provide various options for urinary diversion in patients who require cystectomy. Currently patients who undergo radical cystectomy, anterior pelvic exenteration or total pelvic exenteration for tumors of the pelvic soft tissues, or genitourinary, gynecologic or colorectal system may be candidates for continent diversion directly connected to the remnant urethra or to the skin as a cuta-
neous reservoir. Even in the current era of orthotopic reconstruction CCR remains important for providing an appliance-free diversion alternative in patients who are not candidates for urethral preservation. Early experience with CCR showed that it could be safely created at cystectomy and prospective contemporary studies that meticulously documented the complications associated
0022-5347/09/1825-2376/0 THE JOURNAL OF UROLOGY® Copyright © 2009 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 182, 2376-2381, November 2009 Printed in U.S.A. DOI:10.1016/j.juro.2009.07.038
URETEROILEOCECAL APPENDICOSTOMY URINARY RESERVOIR
with radical cystectomy and urinary diversion show that CCR is not associated with a higher rate of severe complications.1 Longer term studies document that the most common pouch related complications associated with CCR are related to the stoma (difficult catheterization and incontinence) and ureteroenteric connections. Prior pelvic radiation was identified as a risk factor for more frequent pouch related complications after CCR formation.2–5 Numerous variations in technique are used to construct a CCR, of which all share the basic components of a detubularized bowel reservoir and a cutaneous catheterizable stoma that resists urinary flow to maintain continence. The appendix as a catheterizable continence mechanism was first described in the 1980s by Mitrofanoff 6 and later described as part of a modification of the Mainz pouch using a flap valve continence mechanism created by tunneling appendix within the cecal tinea.7 Significant experience with this design showed a high degree of continence, leading to a decreased need for major revision.8 However, concern was raised about using appendix in patients who received high radiation doses.4 Subsequent variations in Mainz appendix based reservoirs consisted of preserving the terminal ileum, such that a tubularized ureteral substitution segment could be fashioned.9,10 To minimize overall urinary reservoir related complications in all patients who undergo CCR formation, particularly in heavily irradiated patients, we have used a modified ileocecal appendicostomy reservoir with a submucosally tunneled appendiceal valve for continence and a tubularized terminal ileal segment as a ureteral substitute to allow a more proximal ureteroenteric anastomosis. We compared our experience with our modified UIA reservoir in previously irradiated and nonirradiated patients.
MATERIALS AND METHODS After receiving institutional review board approval we identified 52 consecutive patients who underwent UIA diversion between March 2001 and January 2008, as done by a single surgeon (BHB). Procedures done before reconstruction included radical cystectomy, or anterior pelvic or total pelvic exenteration. Of the patients 29 received prior or intraoperative radiation therapy and 23 underwent surgery without prior radiation. Patients were selected to undergo UIA diversion after preoperative counseling and assessment of motivation, manual dexterity and adequate renal function (serum creatinine less than 2.5 mg/dl). The UIA pouch was the continent reservoir design of choice, which was constructed in all patients in whom a patent appendix of adequate length and caliber was identified at surgery. Postoperative followup was done at 3 to 4-month intervals for the first 2 years and every 6 months thereafter. Postoperative evaluation was done with physical examination, serum electrolyte analysis and radiography, including computerized
2377
tomography 3 to 4 months postoperatively and every 6 to 12 months thereafter. Early and late complications were defined as those that occurred within 90 and greater than 90 days after surgery, respectively. The focus of this report is on infectious, stomal, pouch and ureterointestinal complications. Reported complications were graded according to the extent of intervention required for management. Any complication resulting from the reservoir that required percutaneous or surgical intervention, prolonged hospitalization or rehospitalization was categorized as major. All other complications were categorized as minor. Data were analyzed using Stata® 8.2 with Fisher’s exact test used to determine p values. Reservoir construction was previously been reported. It consists of 4 components, including continence mechanism creation, reservoir detubularization and formation, completion of the ureteroileal anastomoses and appendiceal stomal maturation.9 Several surgical details require highlighting. The length of terminal ileum left contiguous with the cecum was typically 12 to 15 cm. However, this may be increased to provide the length needed to serve as a partial or total ureteral substitution segment. The total length of right colon segment used for the reservoir segment was 20 cm. The appendix was initially evaluated to determine the adequacy of its length and lumen. A luminal diameter that could accommodate a 12Fr to 14Fr catheter was considered adequate. Full-thickness flaps on each side a of a 4 cm incision along the anterior cecal tinea were developed to create the submucosal tunnel. The appendix was secured in position using seromuscular sutures placed in either side of the cecal wall flaps through the openings made in the first 3 or 4 windows of Deaver in the mesoappendix. Nonpelvic portions of the ureters were used for ureterointestinal connections, particularly in patients with prior radiation therapy, to ensure that a nonirradiated segment was used for anastomosis. Each ureter was stented with 8.5Fr catheters that were temporarily externalized after surgery. The preferred site of stomal placement was at the umbilicus. However, when the umbilical area was deemed unsuitable, an alternative site was chosen in the right lower quadrant.
RESULTS Of the 52 study patients 29 had received radiation therapy, including 18 males (62%) and 11 females (38%), and 23 were nonirradiated, including 15 males (65%) and 8 females (35%). Of patients who received radiation therapy it was intraoperative only in 5 (17%), preoperative only in 10 (34%), preoperative and intraoperative in 13 (45%), and postoperative in 1 (3%). All patients underwent surgical extirpation of pelvic malignancy. Table 1 lists clinical characteristics and primary tumor types. The nonirradiated group consisted of patients with primary bladder cancer, of whom all underwent radical cystectomy or anterior pelvic exenteration. All fe-
2378
URETEROILEOCECAL APPENDICOSTOMY URINARY RESERVOIR
Table 3. Late complications by patient group
Table 1. Patient clinical characteristics and primary tumor histology Characteristic
Nonirradiated
Irradiated
Complication Grade
No. Nonirradiated/ Total No. (%)
No. Irradiated/ Total No. (%)
Av age No. radiation type: Preop Intraop Preop ⫹ intraop Postop No. surgical procedure: Anterior pelvic extenteration Radical cystoprostatectomy Total pelvic exenteration No. gynecologic malignancy site: Cervix Uterus Vagina Vulva No. other malignancy site: Prostate Bladder Sarcoma Rectum
57.1
53.9
Stomal: 1–2 3–4 Pouch: 1–2 3–4 Ureterointestinal: 1–2 3–4 Infectious: 1–2 3–4
5/23 (22) 4 1 0/23 — — 2/44 (5) 0 2 4/23 (17) 2 2
7/29 (24%) 6 1 1/29 (3) — 1 6/56 (11) 0 6 4/29 (14) 3 1
0 0 0 0
10 5 13 1
14 9 0 0 — — — —
9 3 17 16 6 5 3 2
0 23 0 0
7 0 5 1
male nonirradiated patients underwent anterior exenteration and males underwent radical cystoprostatectomy. In the irradiated group 17 patients (59%) underwent total pelvic exenteration with diverting colostomy or ileostomy, while no nonirradiated patients required bowel diversion. Mean ⫾ SD blood loss was 1,232 ⫾ 1,412 ml (95% CI 622, 1,843) in the nonirradiated group and 1,598 ⫾ 1,252 ml (95% CI 1,122, 2,075) in the irradiated group (p ⫽ 0.33). Mean hospital stay was 11.2 ⫾ 6.3 days (95% CI 8.4, 13.8) in the nonirradiated group and 19.4 ⫾ 14.3 days (95% CI 13.9, 28.4) in the irradiated group (p ⫽ 0.013). Mean followup was 26.3 ⫾ 18.8 months (95% CI 18.1, 34.7) in the nonirradiated group and 23.7 ⫾ 18.9 months (95% CI 16.4, 38.9) in the irradiated group (p ⫽ 0.626). A total of 45 patients had more than 6 months of followup and 36 were alive at last followup, includ-
Table 2. Early complications by patient group Complication Grade
No. Nonirradiated (%)
Overall Stomal: 1–2 3–4 Pouch: 1–2 3–4 Ureterointestinal: 1–2 3–4 Infectious: 1–2 3–4
23 4 (17) 2 2 0 — — 0 — — 4 (17) 3 1
No. Irradiated (%) 29 6 1 5 2
p Value
(21)
1.00
(7)
0.50
— 2 1/29 (3) — 1 8 (28) 4 4
0.89
0.51
p Value 0.84
0.37
0.21
0.94
ing 19 of 23 (83%) without and 17 of 29 (59%) with radiation.
COMPLICATIONS Appendiceal/Stomal The incidence of early stoma related complications in the nonirradiated and irradiated group was 17% and 21%, respectively (p ⫽ 1.00, table 2). The incidence of early complications requiring operative intervention was 9% and 17% in the nonirradiated and irradiated groups, respectively (p ⫽ 0.37). All except 1 reoperative procedure was done to revise the stoma. The cause of the observed appendiceal-skin disruptions was early traumatic catheterization or periumbilical wound infection. The incidence of late stomal complications was 22% in the nonirradiated group with 2 of 23 patients (9%) requiring surgical revision secondary to traumatic catheterization and 3 (17%) requiring dilation in the ambulatory setting. The incidence of late stomal complications in the irradiated group was 24% (p ⫽ 0.84, table 3). Seven late stomal complications in the irradiated group consisted of difficult catheterization in 6, which was successfully managed by office dilation. None required surgical revision. Two patients required office dilation and subsequently requested persistent urinary drainage via an indwelling stomal catheter. Another 4 patients reported difficult catheterization and 2 required 1 office dilation each. Ureterointestinal Of the 100 ureteroileal anastomoses 1 early ureterointestinal complication (1%) was observed, consisting of perioperative leak in a previously irradiated patient that resolved within 2 weeks after proximal nephrostomy tube diversion. Late ureteroileal anastomotic complications developed in 2 of 44 renal units (5%) in the nonirradiated group and in 6 of 56 (11%) in the irradiated group (p ⫽ 0.21, table 3). These complica-
URETEROILEOCECAL APPENDICOSTOMY URINARY RESERVOIR
tions were ureteral stricture requiring antegrade endoscopic management after nephrostomy tube placement. One patient subsequently underwent laparoscopic nephrectomy after failed endoscopic management. Reservoir Two early pouch related complications were noted in the nonirradiated group (table 2). One of these complications, which occurred in a previously irradiated patient who underwent total pelvic exenteration, was related to inadvertent pouch injury resulting from emergent reexploration for pelvic bleeding. This caused prolonged urinary leak, which required bilateral percutaneous nephrostomy tubes. An enteropouch fistula subsequently developed and eventually the reservoir was converted to an ileal conduit. The second complication was a pouch leak that resolved after percutaneous drainage. One late pouch complication was identified in an irradiated patient, consisting of a pouch stone that was managed by percutaneous litholopaxy. Urinary Infection The incidence of early infectious complications was 17% in the nonirradiated group and 28% in the irradiated group (p ⫽ 0.51). Three patients in the irradiated group (10%) required rehospitalization or had hospitalization extended because of a urinary tract infection. The incidence of late infectious complications was 17% in the nonirradiated group and 14% in the irradiated group (p ⫽ 0.94). Overall 5% of patients with late infectious complications required hospitalization or intravenous antibiotics.
DISCUSSION We report our results of a right colon continent cutaneous urinary diversion that uses a reliable appendiceal flap valve mechanism and terminal ileum as a ureteral substitution segment in irradiated and nonirradiated patients. This design incorporates and expands established principles. While we and others reported early experience with this reservoir3,10 in irradiated or nonirradiated patients, to our knowledge we report the first comparative evaluation of the 2 groups in consecutive patients. Our analysis shows that irradiated and nonirradiated patients who underwent UIA urinary diversion had similar early and late pouch related complication rates. Our irradiated population consisted of patients who underwent more extensive surgical procedures than the nonirradiated group with total pelvic exenteration in most irradiated patients. Overall surgical morbidity was higher in the total pelvic exenteration group, as evidenced by the prolonged hospital stay, largely related to prolonged postoperative ileus and abdominal infectious complications.
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Continent reservoirs are historically associated with a 20% to 86% complication rate related to reservoir construction, particularly in the setting of prior pelvic irradiation.2,4,11–13 The most common pouch related complications involve the catheterizable limb or stoma and the ureterointestinal anastomosis. Radiation injury to the ureters and small bowel contribute to the higher postoperative complication rate in previously irradiated patients.2,4,11–13 Radiation injury ultimately results in vascular damage, fibrosis and poor tissue viability, which compromise ureteroenteric anastomosis integrity. The reported rate of ureteroenteric complications in previously irradiated patients who undergo continent urinary diversion is from 22% to 37%.4,5,11,13,14 The most common ureteral complications are stricture and anastomotic leak. Ileal reservoirs in previously irradiated patients are associated with a 20% to 37.5% urinary leakage rate and a 7.5% to 25% reoperation rate.2,4,5 The reported complication rate associated with colon pouches in irradiated patients is as high as 86%,4 which is 4-fold higher than that in nonirradiated patients. In those who undergo modified Indiana pouch reconstruction a 5-fold higher ureterointestinal complication rate was reported in irradiated vs nonirradiated patients.15 Wammack et al compared operative outcomes in 36 irradiated and 385 nonirradiated patients who received a Mainz I pouch or a right colon reservoir with an intussuscepted nipple valve.4 The rate of pouch related complications was approximately 86% in irradiated patients vs 23% in the nonirradiated group. The most common complications were leakage (25%), stomal stenosis (39%) and ureterointestinal anastomotic stricture (22%)4 We observed no postoperative stomal incontinence and our stomal stenosis rate compares favorably at 23%. Our overall ureterointestinal complication rate was 7%, that is 4% in nonirradiated and 10% in irradiated patients. UIA reservoir design allows the substitution of lower ureteral segments with terminal ileum. Using the terminal ileum segment for ureteral substitution allows the anastomosis to be created with nonpelvic ureteral segments. Using a well vascularized, nonirradiated segment of proximal ureter in a tensionfree manner is particularly important in patients who have received prior high doses of pelvic radiation. The lower rate of early and late ureterointestinal complications in this study highlights the benefit of this design in a complex group of previously irradiated patients.9 In the nonirradiated setting an advantage of this design allows the substitution of distal ureteral segments that may require excision secondary to tumor involvement, ie transitional cell carcinoma extending into the lower ureteral segments, and the theoretical advantage of having an isoperistaltic limb in place to minimize functional
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URETEROILEOCECAL APPENDICOSTOMY URINARY RESERVOIR
reflux, similar to that of the Studer type afferent limb. The increased segment of terminal ileum did not appear to be associated with an increased rate of intestinal complications such as diarrhea. However, long-term vitamin B12 was not routinely evaluated during followup in most study patients. It appears that the flap valve mechanism created by subserosal tunneling of the appendix in the cecum is superior to the hydraulic valve design for maintaining stomal continence.8 Complications reported with many ileocecal valve based limbs are largely attributable to the efferent limb design.16 They include incontinence, stomal stenosis, difficult catheterization and parastomal hernia.9 Although the continence rate using appendix is excellent, the most common complication was stomal related.8 Of our irradiated patients 15% required surgical stomal revision during the early postoperative period vs 5% in the nonirradiated group. The reason for surgical revision was disruption of the stomal connection to the skin, which resulted from early traumatic catheterization or perioperative wound infection involving the periumbilical region. Late stomal complications consisted exclusively of stomal site nar-
rowing, which was managed by office dilation. Rates of stomal related complications in the literature for the tunneled appendix vs the ileal valve appear comparable.17,18 However, the advantage of improved continence of the appendiceal mechanism is offset by the increased stomal stenosis noted with the appendix stoma.8,17
CONCLUSIONS UIA is effective for providing continent cutaneous diversion of the urinary tract in nonirradiated and previously heavily irradiated patients. Modifications to the previously appendix based stomal mechanisms provide excellent continence with minor pouch related complications. Also, the tubularized ileal segment to allow a more proximal ureter segment provides improved performance of ureterointestinal anastomoses with a lower stenosis rate than previously reported in irradiated patients. Ongoing improvements in surgical techniques for continent urinary diversion can lower the morbidity associated with cutaneous diversion and improve quality of life by minimizing postoperative complications.
REFERENCES 1. Shabsigh A, Korets R, Vora KC et al: Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol 2008; 51: 164. 2. Ahlering TE, Kanellos A, Boyd SD et al: A comparative study of perioperative complications with Kock pouch urinary diversion in highly irradiated versus nonirradiated patients. J Urol 1988; 139: 1202. 3. Bochner BH, Figueroa AJ, Skinner EC et al: Salvage radical cystoprostatectomy and orthotopic urinary diversion following radiation failure. J Urol 1998; 160: 29.
7. Riedmiller H, Burger R, Muller S et al: Continent appendix stoma: a modification of the Mainz pouch technique. J Urol 1990; 143: 1115. 8. Wiesner C, Bonfig R, Stein R et al: Continent cutaneous urinary diversion: long-term follow-up of more than 800 patients with ileocecal reservoirs. World J Urol 2006; 24: 315. 9. Bochner BH, McCreath WA, Aubey JJ et al: Use of an ureteroileocecal appendicostomy urinary reservoir in patients with recurrent pelvic malignancies treated with radiation. Gynecol Oncol 2004; 94: 140.
13. Ravi R, Dewan AK and Pandey KK: Transverse colon conduit urinary diversion in patients treated with very high dose pelvic irradiation. Br J Urol 1994; 73: 51. 14. Leissner J, Black P, Fisch M et al: Colon pouch (Mainz pouch III) for continent urinary diversion after pelvic irradiation. Urology 2000; 56: 798. 15. Wilson TG, Moreno JG, Weinberg A et al: Late complications of the modified Indiana pouch. J Urol 1994; 151: 331. 16. Holmes DG, Thrasher JB, Park GY et al: Longterm complications related to the modified Indiana pouch. Urology 2002; 60: 603.
4. Wammack R, Wricke C and Hohenfellner R: Longterm results of ileocecal continent urinary diversion in patients treated with and without previous pelvic irradiation. J Urol 2002; 167: 2058.
10. Stein JP, Daneshmand S, Dunn M et al: Continent right colon reservoir using a cutaneous appendicostomy. Urology 2004; 63: 577.
5. Wilkin M, Horwitz G, Seetharam A et al: Longterm complications associated with the Indiana pouch urinary diversion in patients with recurrent gynecologic cancers after high-dose radiation. Urol Oncol 2005; 23: 12.
11. Ahlering TE, Weinberg AC and Razor B: A comparative study of the ileal conduit, Kock pouch and modified Indiana pouch. Acta Urol Belg 1991; 59: 303.
17. Gerharz EW, Kohl U, Weingartner K et al: Complications related to different continence mechanisms in ileocecal reservoirs. J Urol 1997; 158: 1709.
12. Mannel RS, Manetta A, Buller RE et al: Use of ileocecal continent urinary reservoir in patients with previous pelvic irradiation. Gynecol Oncol 1995; 59: 376.
18. Gerharz EW, Kohl UN, Melekos MD et al: Ten years’ experience with the submucosally embedded in situ appendix in continent cutaneous diversion. Eur Urol 2001; 40: 625.
6. Mitrofanoff P: Trans-appendicular continent cystostomy in the management of the neurogenic bladder. Chir Pediatr 1980; 21: 297.
EDITORIAL COMMENT These authors report experience with a modified UIA reservoir in 52 irradiated and nonirradiated patients. There were no significant differences in
early or late complication rates between the 2 groups. The most common late complication was stomal stenosis, which occurred in 21% of patients.
URETEROILEOCECAL APPENDICOSTOMY URINARY RESERVOIR
This study provides a contemporary update of a previous experience and shows that UIA is a reasonable option for continent cutaneous urinary diversion in patients with a history of radiation (reference 9 in article). Overall complications are lower than previously described and reported in a standardized manner that permits better comparison to future studies. We must continue to evaluate the suitability of each individual for this form of urinary diversion, especially since there may be wide variation related to the indication for radiation, and type and dose of
2381
radiation used. Furthermore, we should keep in mind that complication rates of other forms of urinary diversion, such as the ileal conduit or colon pouch, may be equal to or less than that of the modified UIA (reference 1 in article). Bowel segments to create the urinary reservoir may 1 day be avoided altogether with advances in bladder stem cell biology and tissue regeneration.1 Mark L. Gonzalgo Department of Urology Stanford University School of Medicine Stanford, California
REFERENCE 1. Atala A, Bauer SB, Soker S et al: Tissue-engineered autologous bladders for patients needing cystoplasty. Lancet 2006; 367: 1241.
Abbreviations and Acronyms CCR ⫽ continent cutaneous reservoir UIA ⫽ ureteroileocecal appendicostomy Submitted for publication March 14, 2009. Study received institutional review board approval. Supported by an Allbritton Foundation grant. * Correspondence: Urology Service, Department of Surgery, Memorial Sloan-Kettering Cancer Center, Kimmel Center for Prostate and Urologic Cancers, 353 East 68th St., New York, New York 10021 (telephone: 646-422-4387; FAX: 212988-0759; e-mail: [email protected]). † Financial interest and/or other relationship with PowerMed Interventions and BK Medical Systems.
Purpose: The ureteroileocecal appendicostomy reservoir is designed to potentially decrease the morbidity of continent diversion, particularly in previously irradiated patients. We report our experience with this reservoir to compare complications in irradiated and nonirradiated patients. Materials and Methods: The records of 52 consecutive patients who underwent ureteroileocecal appendicostomy diversion between March 2001 and January 2008 were evaluated. Outcomes were analyzed according to whether patients received radiation therapy to the pelvis. Complications were reported as early (within 90 days of surgery) or late. Results: Overall 29 patients received radiation therapy. The incidence of early complications requiring operative intervention was 14%, including 2 patients (9%) with and 5 (17%) without radiation (p ⫽ 0.68). All except 1 reoperation was done to revise the stoma. Early urinary tract infections developed in 17% of nonirradiated and 28% of irradiated patients (p ⫽ 0.51). The most common late complication was stomal stenosis requiring dilation on an outpatient basis, which occurred in 21% of patients, including 4 with (17%) and 7 without (24%) radiation (p ⫽ 0.74). Late ureteral complications requiring intervention were reported in 15% of renal units, including 2 of 44 without (5%) and 6 of 56 with (11%) radiation (p ⫽ 0.21). Conclusions: Ureteroileocecal appendicostomy is a safe, effective technique for continent cutaneous urinary diversion in heavily irradiated patients. Complication rates did not significantly differ between irradiated and nonirradiated patients, and appear improved compared to those in previous reports. Key Words: urinary bladder, cystectomy, urinary diversion, urogenital neoplasms, radiotherapy
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ADVANCES in urinary tract reconstruction provide various options for urinary diversion in patients who require cystectomy. Currently patients who undergo radical cystectomy, anterior pelvic exenteration or total pelvic exenteration for tumors of the pelvic soft tissues, or genitourinary, gynecologic or colorectal system may be candidates for continent diversion directly connected to the remnant urethra or to the skin as a cuta-
neous reservoir. Even in the current era of orthotopic reconstruction CCR remains important for providing an appliance-free diversion alternative in patients who are not candidates for urethral preservation. Early experience with CCR showed that it could be safely created at cystectomy and prospective contemporary studies that meticulously documented the complications associated
0022-5347/09/1825-2376/0 THE JOURNAL OF UROLOGY® Copyright © 2009 by AMERICAN UROLOGICAL ASSOCIATION
Vol. 182, 2376-2381, November 2009 Printed in U.S.A. DOI:10.1016/j.juro.2009.07.038
URETEROILEOCECAL APPENDICOSTOMY URINARY RESERVOIR
with radical cystectomy and urinary diversion show that CCR is not associated with a higher rate of severe complications.1 Longer term studies document that the most common pouch related complications associated with CCR are related to the stoma (difficult catheterization and incontinence) and ureteroenteric connections. Prior pelvic radiation was identified as a risk factor for more frequent pouch related complications after CCR formation.2–5 Numerous variations in technique are used to construct a CCR, of which all share the basic components of a detubularized bowel reservoir and a cutaneous catheterizable stoma that resists urinary flow to maintain continence. The appendix as a catheterizable continence mechanism was first described in the 1980s by Mitrofanoff 6 and later described as part of a modification of the Mainz pouch using a flap valve continence mechanism created by tunneling appendix within the cecal tinea.7 Significant experience with this design showed a high degree of continence, leading to a decreased need for major revision.8 However, concern was raised about using appendix in patients who received high radiation doses.4 Subsequent variations in Mainz appendix based reservoirs consisted of preserving the terminal ileum, such that a tubularized ureteral substitution segment could be fashioned.9,10 To minimize overall urinary reservoir related complications in all patients who undergo CCR formation, particularly in heavily irradiated patients, we have used a modified ileocecal appendicostomy reservoir with a submucosally tunneled appendiceal valve for continence and a tubularized terminal ileal segment as a ureteral substitute to allow a more proximal ureteroenteric anastomosis. We compared our experience with our modified UIA reservoir in previously irradiated and nonirradiated patients.
MATERIALS AND METHODS After receiving institutional review board approval we identified 52 consecutive patients who underwent UIA diversion between March 2001 and January 2008, as done by a single surgeon (BHB). Procedures done before reconstruction included radical cystectomy, or anterior pelvic or total pelvic exenteration. Of the patients 29 received prior or intraoperative radiation therapy and 23 underwent surgery without prior radiation. Patients were selected to undergo UIA diversion after preoperative counseling and assessment of motivation, manual dexterity and adequate renal function (serum creatinine less than 2.5 mg/dl). The UIA pouch was the continent reservoir design of choice, which was constructed in all patients in whom a patent appendix of adequate length and caliber was identified at surgery. Postoperative followup was done at 3 to 4-month intervals for the first 2 years and every 6 months thereafter. Postoperative evaluation was done with physical examination, serum electrolyte analysis and radiography, including computerized
2377
tomography 3 to 4 months postoperatively and every 6 to 12 months thereafter. Early and late complications were defined as those that occurred within 90 and greater than 90 days after surgery, respectively. The focus of this report is on infectious, stomal, pouch and ureterointestinal complications. Reported complications were graded according to the extent of intervention required for management. Any complication resulting from the reservoir that required percutaneous or surgical intervention, prolonged hospitalization or rehospitalization was categorized as major. All other complications were categorized as minor. Data were analyzed using Stata® 8.2 with Fisher’s exact test used to determine p values. Reservoir construction was previously been reported. It consists of 4 components, including continence mechanism creation, reservoir detubularization and formation, completion of the ureteroileal anastomoses and appendiceal stomal maturation.9 Several surgical details require highlighting. The length of terminal ileum left contiguous with the cecum was typically 12 to 15 cm. However, this may be increased to provide the length needed to serve as a partial or total ureteral substitution segment. The total length of right colon segment used for the reservoir segment was 20 cm. The appendix was initially evaluated to determine the adequacy of its length and lumen. A luminal diameter that could accommodate a 12Fr to 14Fr catheter was considered adequate. Full-thickness flaps on each side a of a 4 cm incision along the anterior cecal tinea were developed to create the submucosal tunnel. The appendix was secured in position using seromuscular sutures placed in either side of the cecal wall flaps through the openings made in the first 3 or 4 windows of Deaver in the mesoappendix. Nonpelvic portions of the ureters were used for ureterointestinal connections, particularly in patients with prior radiation therapy, to ensure that a nonirradiated segment was used for anastomosis. Each ureter was stented with 8.5Fr catheters that were temporarily externalized after surgery. The preferred site of stomal placement was at the umbilicus. However, when the umbilical area was deemed unsuitable, an alternative site was chosen in the right lower quadrant.
RESULTS Of the 52 study patients 29 had received radiation therapy, including 18 males (62%) and 11 females (38%), and 23 were nonirradiated, including 15 males (65%) and 8 females (35%). Of patients who received radiation therapy it was intraoperative only in 5 (17%), preoperative only in 10 (34%), preoperative and intraoperative in 13 (45%), and postoperative in 1 (3%). All patients underwent surgical extirpation of pelvic malignancy. Table 1 lists clinical characteristics and primary tumor types. The nonirradiated group consisted of patients with primary bladder cancer, of whom all underwent radical cystectomy or anterior pelvic exenteration. All fe-
2378
URETEROILEOCECAL APPENDICOSTOMY URINARY RESERVOIR
Table 3. Late complications by patient group
Table 1. Patient clinical characteristics and primary tumor histology Characteristic
Nonirradiated
Irradiated
Complication Grade
No. Nonirradiated/ Total No. (%)
No. Irradiated/ Total No. (%)
Av age No. radiation type: Preop Intraop Preop ⫹ intraop Postop No. surgical procedure: Anterior pelvic extenteration Radical cystoprostatectomy Total pelvic exenteration No. gynecologic malignancy site: Cervix Uterus Vagina Vulva No. other malignancy site: Prostate Bladder Sarcoma Rectum
57.1
53.9
Stomal: 1–2 3–4 Pouch: 1–2 3–4 Ureterointestinal: 1–2 3–4 Infectious: 1–2 3–4
5/23 (22) 4 1 0/23 — — 2/44 (5) 0 2 4/23 (17) 2 2
7/29 (24%) 6 1 1/29 (3) — 1 6/56 (11) 0 6 4/29 (14) 3 1
0 0 0 0
10 5 13 1
14 9 0 0 — — — —
9 3 17 16 6 5 3 2
0 23 0 0
7 0 5 1
male nonirradiated patients underwent anterior exenteration and males underwent radical cystoprostatectomy. In the irradiated group 17 patients (59%) underwent total pelvic exenteration with diverting colostomy or ileostomy, while no nonirradiated patients required bowel diversion. Mean ⫾ SD blood loss was 1,232 ⫾ 1,412 ml (95% CI 622, 1,843) in the nonirradiated group and 1,598 ⫾ 1,252 ml (95% CI 1,122, 2,075) in the irradiated group (p ⫽ 0.33). Mean hospital stay was 11.2 ⫾ 6.3 days (95% CI 8.4, 13.8) in the nonirradiated group and 19.4 ⫾ 14.3 days (95% CI 13.9, 28.4) in the irradiated group (p ⫽ 0.013). Mean followup was 26.3 ⫾ 18.8 months (95% CI 18.1, 34.7) in the nonirradiated group and 23.7 ⫾ 18.9 months (95% CI 16.4, 38.9) in the irradiated group (p ⫽ 0.626). A total of 45 patients had more than 6 months of followup and 36 were alive at last followup, includ-
Table 2. Early complications by patient group Complication Grade
No. Nonirradiated (%)
Overall Stomal: 1–2 3–4 Pouch: 1–2 3–4 Ureterointestinal: 1–2 3–4 Infectious: 1–2 3–4
23 4 (17) 2 2 0 — — 0 — — 4 (17) 3 1
No. Irradiated (%) 29 6 1 5 2
p Value
(21)
1.00
(7)
0.50
— 2 1/29 (3) — 1 8 (28) 4 4
0.89
0.51
p Value 0.84
0.37
0.21
0.94
ing 19 of 23 (83%) without and 17 of 29 (59%) with radiation.
COMPLICATIONS Appendiceal/Stomal The incidence of early stoma related complications in the nonirradiated and irradiated group was 17% and 21%, respectively (p ⫽ 1.00, table 2). The incidence of early complications requiring operative intervention was 9% and 17% in the nonirradiated and irradiated groups, respectively (p ⫽ 0.37). All except 1 reoperative procedure was done to revise the stoma. The cause of the observed appendiceal-skin disruptions was early traumatic catheterization or periumbilical wound infection. The incidence of late stomal complications was 22% in the nonirradiated group with 2 of 23 patients (9%) requiring surgical revision secondary to traumatic catheterization and 3 (17%) requiring dilation in the ambulatory setting. The incidence of late stomal complications in the irradiated group was 24% (p ⫽ 0.84, table 3). Seven late stomal complications in the irradiated group consisted of difficult catheterization in 6, which was successfully managed by office dilation. None required surgical revision. Two patients required office dilation and subsequently requested persistent urinary drainage via an indwelling stomal catheter. Another 4 patients reported difficult catheterization and 2 required 1 office dilation each. Ureterointestinal Of the 100 ureteroileal anastomoses 1 early ureterointestinal complication (1%) was observed, consisting of perioperative leak in a previously irradiated patient that resolved within 2 weeks after proximal nephrostomy tube diversion. Late ureteroileal anastomotic complications developed in 2 of 44 renal units (5%) in the nonirradiated group and in 6 of 56 (11%) in the irradiated group (p ⫽ 0.21, table 3). These complica-
URETEROILEOCECAL APPENDICOSTOMY URINARY RESERVOIR
tions were ureteral stricture requiring antegrade endoscopic management after nephrostomy tube placement. One patient subsequently underwent laparoscopic nephrectomy after failed endoscopic management. Reservoir Two early pouch related complications were noted in the nonirradiated group (table 2). One of these complications, which occurred in a previously irradiated patient who underwent total pelvic exenteration, was related to inadvertent pouch injury resulting from emergent reexploration for pelvic bleeding. This caused prolonged urinary leak, which required bilateral percutaneous nephrostomy tubes. An enteropouch fistula subsequently developed and eventually the reservoir was converted to an ileal conduit. The second complication was a pouch leak that resolved after percutaneous drainage. One late pouch complication was identified in an irradiated patient, consisting of a pouch stone that was managed by percutaneous litholopaxy. Urinary Infection The incidence of early infectious complications was 17% in the nonirradiated group and 28% in the irradiated group (p ⫽ 0.51). Three patients in the irradiated group (10%) required rehospitalization or had hospitalization extended because of a urinary tract infection. The incidence of late infectious complications was 17% in the nonirradiated group and 14% in the irradiated group (p ⫽ 0.94). Overall 5% of patients with late infectious complications required hospitalization or intravenous antibiotics.
DISCUSSION We report our results of a right colon continent cutaneous urinary diversion that uses a reliable appendiceal flap valve mechanism and terminal ileum as a ureteral substitution segment in irradiated and nonirradiated patients. This design incorporates and expands established principles. While we and others reported early experience with this reservoir3,10 in irradiated or nonirradiated patients, to our knowledge we report the first comparative evaluation of the 2 groups in consecutive patients. Our analysis shows that irradiated and nonirradiated patients who underwent UIA urinary diversion had similar early and late pouch related complication rates. Our irradiated population consisted of patients who underwent more extensive surgical procedures than the nonirradiated group with total pelvic exenteration in most irradiated patients. Overall surgical morbidity was higher in the total pelvic exenteration group, as evidenced by the prolonged hospital stay, largely related to prolonged postoperative ileus and abdominal infectious complications.
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Continent reservoirs are historically associated with a 20% to 86% complication rate related to reservoir construction, particularly in the setting of prior pelvic irradiation.2,4,11–13 The most common pouch related complications involve the catheterizable limb or stoma and the ureterointestinal anastomosis. Radiation injury to the ureters and small bowel contribute to the higher postoperative complication rate in previously irradiated patients.2,4,11–13 Radiation injury ultimately results in vascular damage, fibrosis and poor tissue viability, which compromise ureteroenteric anastomosis integrity. The reported rate of ureteroenteric complications in previously irradiated patients who undergo continent urinary diversion is from 22% to 37%.4,5,11,13,14 The most common ureteral complications are stricture and anastomotic leak. Ileal reservoirs in previously irradiated patients are associated with a 20% to 37.5% urinary leakage rate and a 7.5% to 25% reoperation rate.2,4,5 The reported complication rate associated with colon pouches in irradiated patients is as high as 86%,4 which is 4-fold higher than that in nonirradiated patients. In those who undergo modified Indiana pouch reconstruction a 5-fold higher ureterointestinal complication rate was reported in irradiated vs nonirradiated patients.15 Wammack et al compared operative outcomes in 36 irradiated and 385 nonirradiated patients who received a Mainz I pouch or a right colon reservoir with an intussuscepted nipple valve.4 The rate of pouch related complications was approximately 86% in irradiated patients vs 23% in the nonirradiated group. The most common complications were leakage (25%), stomal stenosis (39%) and ureterointestinal anastomotic stricture (22%)4 We observed no postoperative stomal incontinence and our stomal stenosis rate compares favorably at 23%. Our overall ureterointestinal complication rate was 7%, that is 4% in nonirradiated and 10% in irradiated patients. UIA reservoir design allows the substitution of lower ureteral segments with terminal ileum. Using the terminal ileum segment for ureteral substitution allows the anastomosis to be created with nonpelvic ureteral segments. Using a well vascularized, nonirradiated segment of proximal ureter in a tensionfree manner is particularly important in patients who have received prior high doses of pelvic radiation. The lower rate of early and late ureterointestinal complications in this study highlights the benefit of this design in a complex group of previously irradiated patients.9 In the nonirradiated setting an advantage of this design allows the substitution of distal ureteral segments that may require excision secondary to tumor involvement, ie transitional cell carcinoma extending into the lower ureteral segments, and the theoretical advantage of having an isoperistaltic limb in place to minimize functional
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URETEROILEOCECAL APPENDICOSTOMY URINARY RESERVOIR
reflux, similar to that of the Studer type afferent limb. The increased segment of terminal ileum did not appear to be associated with an increased rate of intestinal complications such as diarrhea. However, long-term vitamin B12 was not routinely evaluated during followup in most study patients. It appears that the flap valve mechanism created by subserosal tunneling of the appendix in the cecum is superior to the hydraulic valve design for maintaining stomal continence.8 Complications reported with many ileocecal valve based limbs are largely attributable to the efferent limb design.16 They include incontinence, stomal stenosis, difficult catheterization and parastomal hernia.9 Although the continence rate using appendix is excellent, the most common complication was stomal related.8 Of our irradiated patients 15% required surgical stomal revision during the early postoperative period vs 5% in the nonirradiated group. The reason for surgical revision was disruption of the stomal connection to the skin, which resulted from early traumatic catheterization or perioperative wound infection involving the periumbilical region. Late stomal complications consisted exclusively of stomal site nar-
rowing, which was managed by office dilation. Rates of stomal related complications in the literature for the tunneled appendix vs the ileal valve appear comparable.17,18 However, the advantage of improved continence of the appendiceal mechanism is offset by the increased stomal stenosis noted with the appendix stoma.8,17
CONCLUSIONS UIA is effective for providing continent cutaneous diversion of the urinary tract in nonirradiated and previously heavily irradiated patients. Modifications to the previously appendix based stomal mechanisms provide excellent continence with minor pouch related complications. Also, the tubularized ileal segment to allow a more proximal ureter segment provides improved performance of ureterointestinal anastomoses with a lower stenosis rate than previously reported in irradiated patients. Ongoing improvements in surgical techniques for continent urinary diversion can lower the morbidity associated with cutaneous diversion and improve quality of life by minimizing postoperative complications.
REFERENCES 1. Shabsigh A, Korets R, Vora KC et al: Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology. Eur Urol 2008; 51: 164. 2. Ahlering TE, Kanellos A, Boyd SD et al: A comparative study of perioperative complications with Kock pouch urinary diversion in highly irradiated versus nonirradiated patients. J Urol 1988; 139: 1202. 3. Bochner BH, Figueroa AJ, Skinner EC et al: Salvage radical cystoprostatectomy and orthotopic urinary diversion following radiation failure. J Urol 1998; 160: 29.
7. Riedmiller H, Burger R, Muller S et al: Continent appendix stoma: a modification of the Mainz pouch technique. J Urol 1990; 143: 1115. 8. Wiesner C, Bonfig R, Stein R et al: Continent cutaneous urinary diversion: long-term follow-up of more than 800 patients with ileocecal reservoirs. World J Urol 2006; 24: 315. 9. Bochner BH, McCreath WA, Aubey JJ et al: Use of an ureteroileocecal appendicostomy urinary reservoir in patients with recurrent pelvic malignancies treated with radiation. Gynecol Oncol 2004; 94: 140.
13. Ravi R, Dewan AK and Pandey KK: Transverse colon conduit urinary diversion in patients treated with very high dose pelvic irradiation. Br J Urol 1994; 73: 51. 14. Leissner J, Black P, Fisch M et al: Colon pouch (Mainz pouch III) for continent urinary diversion after pelvic irradiation. Urology 2000; 56: 798. 15. Wilson TG, Moreno JG, Weinberg A et al: Late complications of the modified Indiana pouch. J Urol 1994; 151: 331. 16. Holmes DG, Thrasher JB, Park GY et al: Longterm complications related to the modified Indiana pouch. Urology 2002; 60: 603.
4. Wammack R, Wricke C and Hohenfellner R: Longterm results of ileocecal continent urinary diversion in patients treated with and without previous pelvic irradiation. J Urol 2002; 167: 2058.
10. Stein JP, Daneshmand S, Dunn M et al: Continent right colon reservoir using a cutaneous appendicostomy. Urology 2004; 63: 577.
5. Wilkin M, Horwitz G, Seetharam A et al: Longterm complications associated with the Indiana pouch urinary diversion in patients with recurrent gynecologic cancers after high-dose radiation. Urol Oncol 2005; 23: 12.
11. Ahlering TE, Weinberg AC and Razor B: A comparative study of the ileal conduit, Kock pouch and modified Indiana pouch. Acta Urol Belg 1991; 59: 303.
17. Gerharz EW, Kohl U, Weingartner K et al: Complications related to different continence mechanisms in ileocecal reservoirs. J Urol 1997; 158: 1709.
12. Mannel RS, Manetta A, Buller RE et al: Use of ileocecal continent urinary reservoir in patients with previous pelvic irradiation. Gynecol Oncol 1995; 59: 376.
18. Gerharz EW, Kohl UN, Melekos MD et al: Ten years’ experience with the submucosally embedded in situ appendix in continent cutaneous diversion. Eur Urol 2001; 40: 625.
6. Mitrofanoff P: Trans-appendicular continent cystostomy in the management of the neurogenic bladder. Chir Pediatr 1980; 21: 297.
EDITORIAL COMMENT These authors report experience with a modified UIA reservoir in 52 irradiated and nonirradiated patients. There were no significant differences in
early or late complication rates between the 2 groups. The most common late complication was stomal stenosis, which occurred in 21% of patients.
URETEROILEOCECAL APPENDICOSTOMY URINARY RESERVOIR
This study provides a contemporary update of a previous experience and shows that UIA is a reasonable option for continent cutaneous urinary diversion in patients with a history of radiation (reference 9 in article). Overall complications are lower than previously described and reported in a standardized manner that permits better comparison to future studies. We must continue to evaluate the suitability of each individual for this form of urinary diversion, especially since there may be wide variation related to the indication for radiation, and type and dose of
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radiation used. Furthermore, we should keep in mind that complication rates of other forms of urinary diversion, such as the ileal conduit or colon pouch, may be equal to or less than that of the modified UIA (reference 1 in article). Bowel segments to create the urinary reservoir may 1 day be avoided altogether with advances in bladder stem cell biology and tissue regeneration.1 Mark L. Gonzalgo Department of Urology Stanford University School of Medicine Stanford, California
REFERENCE 1. Atala A, Bauer SB, Soker S et al: Tissue-engineered autologous bladders for patients needing cystoplasty. Lancet 2006; 367: 1241.