Reconstructive Urology Anterior Fascial Fixation Does Not Reduce the Parastomal Hernia Rate After Radical Cystectomy and Ileal Conduit Andrew L. Pisters, Ashish M. Kamat, Wei Wei, Dan Leibovici, Jun Liu, H. Barton Grossman, and Charles E. Butler OBJECTIVE
To compare the rate of parastomal hernia in patients undergoing anterior fascial ﬁxation of the ileal conduit with that in patients without fascial ﬁxation. Limited data exist on whether anterior fascial ﬁxation of the ileal conduit impacts the rate of parastomal hernia. A total of 496 consecutive patients undergoing radical cystectomy and ileal conduit reconstruction from 1995 to 2012 were retrospectively evaluated for parastomal hernia. All patients had a 2-ﬁngerbreadth aperture and the ileal conduit brought through the rectus muscle and sheath. Patients were divided into 1 of 3 groups based on stoma ﬁxation and/or reinforcement: anterior fascial ﬁxation, posterior reinforcement, or no fascial ﬁxation. A parastomal hernia was deﬁned as a palpable bulge at the stoma site. Multivariate logistic regression was conducted for the primary end point of parastomal hernia, controlling for other patient- and treatment-related factors that might affect the rate of parastomal hernia. Median follow-up was 16 months (range, 1-189 months). The parastomal hernia rate was signiﬁcantly greater in the anterior fascial suture group (43 of 281; 15.3%) than the no fascial suture group (12 of 164; 7.3%; P ¼ .02). Multivariate logistic regression analysis modeled for the occurrence of a parastomal hernia demonstrated that anterior fascial ﬁxation was an independent predictor of the development of parastomal hernia (odds ratio, 2.3; 95% conﬁdence interval, 1.03-5.14; P ¼ .04). Anterior fascial ﬁxation of the ileal conduit does not reduce the risk of parastomal hernia formation compared with the patients treated without fascial ﬁxation. Surgeons should consider avoiding anterior suture ﬁxation during ileal conduit creation. UROLOGY -: -e-, 2014. 2014 Elsevier Inc.
arastomal hernia occurs in about 14% of patients undergoing ileal conduit diversion after radical cystectomy.1 One of the reported risk factors for the development of parastomal hernia is obesity.2,3 The presence of a parastomal hernia can cause pain, discomfort, difﬁculty with clothes ﬁtting properly, and signiﬁcant anxiety related to poor appliance ﬁt and risk for urine leak. The presence of a parastomal hernia has been shown to impair quality of life in 3 domains of a general health scale and on a separate stoma-speciﬁc quality of life instrument.4 Monitoring cystectomy patients for the
Financial Disclosure: Ashish M. Kamat has ﬁnancial interests with Abbott, Photocure, Cubist, Sanoﬁ, Ferring Pharm., and FKD Industries. The remaining authors declare that they have no relevant ﬁnancial interests. From the Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX; the Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX; the Department of Urology, Assaf Harofeh Medical Center, Zeriﬁn, Israel; and the Department of Plastic Surgery, University of Texas MD Anderson Cancer Center, Houston, TX Reprint requests: Andrew L. Pisters, B.Sc., Department of Urology, The University of Texas MD Anderson Cancer Center, Unit 1373, 1515 Holcombe Boulevard, Houston, TX 77030. E-mail: [email protected]
Submitted: September 16, 2013, accepted (with revisions): January 8, 2014
ª 2014 Elsevier Inc. All Rights Reserved
development of parastomal hernia is an important component of follow-up after surgical treatment of bladder cancer and should not be overlooked when reporting long-term diversion complications. Many parastomal hernias occurring in patients with ileal conduits are small and can be observed, particularly if the patient is asymptomatic and willing to live with the bulge. Patients who dislike the bulge or have mild-to-moderate symptoms from the hernia could consider a trial of using a truss. Indications for surgical treatment of parastomal hernia include pain, intestinal obstruction, incarceration, poor appliance ﬁt and/or leak, massive size, and skin ulceration. Treatment of parastomal hernia can be a major undertaking involving either in situ hernia repair with or without mesh or stoma relocation to another site with original stoma site defect repair.5,6 There are limited studies evaluating the extent to which surgical technique may inﬂuence the risk of parastomal hernia. The paramount technical issues include ostomy location, aperture size, and the use of fascial tacking sutures. This study explores the inﬂuence of fascial tacking sutures in patients undergoing a speciﬁc 0090-4295/14/$36.00 http://dx.doi.org/10.1016/j.urology.2014.01.041
Table 1. Deﬁnition of patient characteristics, disease and treatment factors, and outcome measures Variable Age BMI Prior abdominal surgery Prior inguinal hernia repair Prior ventral hernia repair COPD Prior steroids Neoadjuvant chemotherapy Neoadjuvant bevacizunab Adjuvant chemotherapy Salvage chemotherapy Parastomal hernia Postoperative pneumonia Postoperative ventral incisional hernia Surgical site occurrence Wound dehiscence
Deﬁnition Patient age in years at the time of cystectomy BMI ¼ (weight in pounds/[height in inches height in inches]) 703 within 1 mo of cystectomy Any prior operation in the abdominal cavity, pelvis, or retroperitoneum via an anterior approach (eg, appendectomy, colectomy, radical prostatectomy, cholecystectomy, and hysterectomy) Prior direct or indirect inguinal hernia repair, any approach Any patient with a history of abdominal surgery who then developed an incisional hernia which was repaired before the time of cystectomy and urinary diversion Diagnosis of COPD made before cystectomy and ileal conduit Chronic steroid use (minimum of 4 continuous weeks within 6 wk of cystectomy and ileal conduit) Systemic chemotherapy received after diagnosis of invasive bladder cancer and before cystectomy and ileal conduit Bevacizunab received after diagnosis of invasive bladder cancer and before cystectomy and ileal conduit Systemic chemotherapy given within a 6-mo period after radical cystectomy and ileal conduit, in an effort to reduce the risk of disease recurrence in a patient who was clinically disease free Systemic chemotherapy administered for documented urothelial carcinoma recurrence after cystectomy and ileal conduit A palpable bulge with associated fascial defect at the ileal conduit stoma site on follow-up outpatient clinical examination Clinical lung infection requiring antibiotic treatment within the period of hospitalization after cystectomy A palpable bulge with associated fascial defect in the midline incision made for cystectomy and ileal conduit. Any separation of the midline incision requiring wound care such as packing, wet-to-dry dressing changes, or wound VAC. This term encompasses patients with sterile wound seromas that resulted in wound separation. Separation of the abdominal fascia requiring operative fascial reclosure
BMI, body mass index; COPD, chronic obstructive pulmonary disease; VAC, vacuum-assisted closure.
type of ostomy (ileal conduit after cystectomy) with a uniform ostomy location through the rectus muscle and consistent aperture size (2-ﬁnger diameter). We compared 2 main approaches to fascial ﬁxation after transposing the ileal conduit through the rectus muscle. Anterior fascial ﬁxation typically involves the placement of between 4 and 8 interrupted resorbable sutures between the ileal conduit and the anterior rectus sheath. Posterior reinforcement involves the placement of 1 to 3 interrupted sutures in the posterior rectus sheath and/or peritoneum to tighten and/or reinforce the medial aspect of the aperture where the conduit exits the abdomen. A completely different approach to creating the ileal conduit stoma is to avoid anterior fascial or posterior sutures altogether (no ﬁxation). The primary objective of this study was to compare the incidence of parastomal hernia with these 3 different surgical approaches to stoma formation. We hypothesized that fascial ﬁxation would be beneﬁcial in reducing the rate of parastomal hernia.
MATERIALS AND METHODS This study was approved by M.D. Anderson’s Institutional Review Board. The medical records of all consecutive patients who underwent radical cystectomy and ileal conduit reconstruction from July 1994 to August 2010 were retrospectively 2
reviewed. Patients with existing colostomies or ventral hernias were included, but patients who had undergone a previous ileal conduit were excluded. Patients undergoing cystectomy with alternative urinary diversions such as Indiana pouch or Studer orthotopic urinary diversion were also excluded. Patients were censored from further analysis if they were found to have a parastomal hernia on physical examination or died. Patient characteristics, disease and treatment factors, and outcomes were recorded and analyzed according to speciﬁc deﬁnitions provided in Table 1. The primary objective was to compare the incidence of parastomal hernia among patients undergoing anterior ﬁxation, posterior reinforcement, and no facial ﬁxation.
Outcome Measures A patient was considered to have a parastomal hernia (primary outcome measure) based on a physical examination during serial urology follow-up clinic visits. Parastomal hernia was deﬁned as a palpable bulge with associated fascial defect at the ileal conduit stoma site on follow-up outpatient clinical examination. A comparison of patient characteristics and disease and treatment factors based on the fascial ﬁxation group is shown in Table 2.
Surgical Technique The 3 urologists in this study were each uro-oncology fellowship trained and had high-volume cystectomy practices. All patients were marked preoperatively for the stoma location by a certiﬁed ostomy nurse. Each surgeon worked independently and created UROLOGY
Table 2. Comparison of patient characteristics and disease and treatment factors based on the fascial ﬁxation group Variable Follow-up months, mean (range) Age, mean (range) BMI (kg/m2) 40 Parastomal hernia Prior abdominal surgery Prior inguinal hernia repair Prior ventral hernia repair Prior steroids COPD Neoadjuvant chemotherapy Neoadjuvant bevucizumab Adjuvant chemotherapy Pathologic stage T0 Ta/Tis T1 T2/T3 T4 Positive lymph nodes Salvage chemotherapy Surgical site occurrence Wound dehiscence Postoperative pneumonia Postoperative ventral incisional hernia
Anterior Fixation, n ¼ 281 (%)
Posterior Reinforcement, n ¼ 51 (%)
No Fixation, n ¼ 164 (%)
25.3 (0.2-168.3) 71.3 (41-93)
25.0 (0.4-87.8) 74.6 (41-91)
25.1 (0.3-188.9) 70.0 (42-87)
202 67 12 43 111 40 8 10 25 107 7 38
(58.2) (54.9) (46.2) (15.3) (39.5) (14.2) (2.8) (3.6) (8.8) (38.1) (2.5) (13.5)
33 16 2 6 32 10 4 2 6 17 0 7
(9.5) (13.1) (7.7) (11.8) (62.7) (19.6) (7.8) (3.9) (11.7) (33.3) (0) (13.7)
112 39 12 12 78 24 5 1 13 62 2 28
(32.3) (32.0) (46.2) (7.3) (47.5) (14.6) (3.0) (0.6) (7.9) (37.8) (0.8) (17.1)
.48 .04 .006 .61 .19 .14 .70 .81 .37 .58
50 65 22 124 19 56 13 9 13 6 18
(67.6) (57.0) (48.9) (56.4) (45.2) (60.2) (4.6) (3.2) (4.6) (2.1) (6.4)
4 12 4 22 9 6 0 1 4 5 5
(5.4) (10.5) (8.9) (10.0) (21.4) (6.5) (0) (2.0) (7.8) (9.8) (9.8)
20 37 19 74 14 31 8 7 5 9 12
(27.3) (32.5) (42.2) (33.6) (33.3) (33.3) (4.9) (4.3) (3.0) (5.5) (7.3)
.16 .39 .28 .70 .34 .02 .68
Abbreviations as in Table 1. Bold values indicate a direct comparison of anterior ﬁxation group to no ﬁxation group.
end stomas in a consistent manner including a 2-ﬁngerbreadth aperture in the abdominal wall through the separated rectus muscle ﬁbers and matured the stoma to the skin with interrupted absorbable sutures. The type of ﬁxation was based on the discretion of the attending surgeon for each case. Anterior ﬁxation was accomplished by placing between four and eight 20 polyglactin sutures between the anterior rectus sheath and the ileal conduit (Fig. 1A,B). Posterior reinforcement involved placing from 1 to 3 interrupted 0-polyglactin sutures in the posterior rectus sheath and peritoneum (Fig. 1C).
Statistical Analysis Summary statistics of patient characteristics are provided for the 3 groups in the form of frequency tables and percentages. Patients’ age and body mass index (BMI) are summarized by mean, standard deviation , and range. BMI was analyzed as both a continuous variable and categorically as deﬁned by the World Health Organization groupings: group 1—underweight, normal, and preobese (BMI 40 kg/m2).7 Correlation between clinical factors and ﬁxation groups was evaluated using the Fisher exact test. Correlation between continuous outcomes (age, BMI, etc) and ﬁxation groups was assessed using the Kruskal-Wallis test. A logistic regression model with backward elimination was used to identify a ﬁnal multivariate model predicting the parastomal hernia status. The backward elimination procedure started from all predictors and eliminated the most insigniﬁcant factor at each step until all remaining factors were signiﬁcant (ie, P value