Comparison of Health Care Utilization and Costs Between Patients with Perianal Fistulizing Crohn's Disease Treated with Biologics with or Without Previous Seton Placement.

BACKGROUND: Fistulas are a common and often debilitating complication of Crohn's disease (CD). Tumor necrosis factor inhibitors and/or seton drainage are effective treatment options. We compared health care utilization and costs for patients with perianal CD who had setons placed before treatment with biologics versus those who did not. METHODS: Patients with CD (≥18 yr) were identified from the Truven Health MarketScan Database by ICD-9 code 555.x (January 1, 2006-March 31, 2015); those with external fistulas were identified by ICD-9 codes 565.1. Biological treatment and seton procedures were identified with the National Drug Codes or Current Procedural Terminology codes. Patients were grouped into 2 cohorts: seton before biological (SBB) treatment or no seton before biological (NSBB) treatment. RESULTS: SBB (N = 326) and NSBB (N = 1519) groups were similar in baseline age, sex, use of immunosuppressants and steroids, and comorbidity score. Baseline prevalence of asthma and cardiovascular disease, and use of antibiotics and 5-aminosalicylic acid were significantly greater in the SBB group versus the NSBB group. Baseline number of all-cause and fistula-related hospitalizations were greater for the SBB group than in the NSBB group. However, during follow-up, the NSBB group required significantly more hospitalizations than the SBB group (all-cause: 0.41 versus 0.23; fistula related: 0.16 versus 0.07) and had significantly greater health care costs (all-cause: $9711 versus $5514; fistula related: $4156 versus $1900). Results were confirmed in multivariate regressions adjusting for baseline characteristics and prescription drug use. CONCLUSIONS: Patients who had the setons placed before treatment with biologics used fewer health care resources and incurred lower health care costs compared with those who did not have the procedure.

Direct and indirect costs for anal fistula in Sweden.

INTRODUCTION: Anal fistula is an abnormal tract with an external and internal opening that cause leakage, discomfort, and occasionally pain. Surgery is standard treatment, but recurrence and anal incontinence is common. The objective of the study was to analyze resource use, costs and sick leave for newly diagnosed patients with anal fistula in Sweden. METHODS: The study was based on register data from linkages between Swedish population-based registers including patients treated for anal fistula in Västra Götaland County, Sweden. Health care resource use, costs and sick leave were estimated. RESULTS: The sample included 362 patients of which 27% had no surgery, 37% had one surgery and 36% had multiple surgeries. Patients with multiple surgeries underwent over four surgeries on average. Approximately 67% of the contacts occurred during the first year after diagnosis. Estimated mean sick leave was 10.4 full-time equivalent days per patient. Total discounted costs were €5,561 per patient where approximately 80% were direct costs. DISCUSSION: To our knowledge this is the first study of resource use, costs and sick leave related to anal fistulas. The study indicates that anal fistula is a condition that is costly for society and that the burden of anal fistula in terms of health care resources and sick leave is especially high for patients experiencing multiple surgeries. CONCLUSION: Anal fistula is a condition that is costly for society and there is an unmet need for the group of patients with multiple surgeries to find appropriate treatment interventions.

Bacteriological study in perianal abscess is not useful and not cost-effective.

BACKGROUND: The detection of gut organisms in perianal abscesses has been postulated to suggest an underlying communication with the anal canal. However, recent studies appear to contradict this observation. The aim of this study is to determine the value of bacteriological studies in perianal abscesses. METHODS: A retrospective study of all patients who have had a surgical drainage of their perianal abscesses with concomitant microbiological examination from January 2010 to December 2012 was performed. Patients with known underlying anal fistula, Crohn's disease or previous perianal operations were excluded. RESULTS: A total of 164 patients, median age of 42.0 years (range 8-87) comprising of 78.7% males formed the study group. Gut organisms were cultured in 143 (87.2%) samples while 12 (7.3%) demonstrated skin organisms and nine did not yield any bacterial growth (5.5%). Twenty-nine (17.7%) patients developed anal fistula and 34 (20.7%) patients had a recurrence of the perianal abscess. The median follow-up period was 1450 (14-2391) days. There was no significant association between the presence of gut organism and development of fistulas (odds ratio = 0.48; 95% confidence interval = 0.17-1.37) or recurrence of perianal abscess (odds ratio = 1.66; 95% confidence interval = 0.46-6.01). CONCLUSION: Bacteriological culture in perianal abscess is not useful for predicting the development of anal fistula or abscess recurrence. Hence, there is no need to perform this investigation on a routine basis.

Multimodal treatment of perianal fistulas in Crohn's disease: seton versus anti-TNF versus advancement plasty (PISA): study protocol for a randomized controlled trial.

BACKGROUND: Currently there is no guideline for the treatment of patients with Crohn's disease and high perianal fistulas. Most patients receive anti-TNF medication, but no long-term results of this expensive medication have been described, nor has its efficiency been compared to surgical strategies. With this study, we hope to provide treatment consensus for daily clinical practice with reduction in costs. METHODS/DESIGN: This is a multicentre, randomized controlled trial. Patients with Crohn's disease who are over 18 years of age, with newly diagnosed or recurrent active high perianal fistulas, with one internal opening and no anti-TNF usage in the past three months will be considered. Patients with proctitis, recto-vaginal fistulas or anal stenosis will be excluded. Prior to randomisation, an MRI and ileocolonoscopy are required. All treatment will start with seton placement and a course of antibiotics. Patients will then be randomised to: (1) chronic seton drainage (with oral 6-mercaptopurine (6MP)) for one year, (2) anti-TNF medication (with 6MP) for one year (seton removal after six weeks) or (3) advancement plasty after eight weeks of seton drainage (under four months anti-TNF and 6MP for one year). The primary outcome parameter is the number of patients needing fistula-related re-intervention(s). Secondary outcomes are the number of patients with closed fistulas (based on an evaluated MRI score) after 18 months, disease activity, quality of life and costs. DISCUSSION: The PISA trial is a multicentre, randomised controlled trial of patients with Crohn's disease and high perianal fistulas. With the comparison of three generally accepted treatment strategies, we will be able to comment on the efficiency of the various treatment strategies, with respect to several long-term outcome parameters. TRIAL REGISTRATION: Nederlands Trial Register identifier: NTR4137 (registered on 23 August 2013).

The impact of perianal disease in young patients with inflammatory bowel disease.

BACKGROUND: Perianal disease is a potentially significant source of morbidity for patients with inflammatory bowel disease (IBD). We sought to identify the impact of perianal disease on IBD outcomes in children, adolescents, and young adults. METHODS: We studied 12,465 inpatient admissions for patients ≤20 years old with IBD in 2009 using the Kids' Inpatient Database (KID). Patients were stratified by their principal diagnosis of ulcerative colitis (UC) or Crohn's disease (CD). Perianal disease (perianal abscess, anal fissure, or anal fistula), complex fistulas (rectourethral, rectovaginal, or enterovesical), and growth failure were defined by ICD-9 codes. Logistic regression was performed adjusting for CD or UC, gender, age, need for surgical intervention, fistulas, or growth failure. RESULTS: Of the 511 (4.1%) patients with perianal disease, 480 had CD (94%, p < 0.001). Girls were less likely to suffer perianal disease (OR = 0.63, CI 0.52-0.76, p < 0.001). Those with perianal disease were more likely to suffer complex fistulas (OR = 3.5, CI 1.98-6.20, p < 0.001) but less likely to suffer enteroenteral fistulas (OR = 0.30, CI 0.15-0.63, p = 0.001) than those without perianal disease. Perianal disease did not increase the incidence of growth failure (p = 0.997) but doubled the likelihood of an operation of any type during admission (p < 0.001). Additionally, patients with perianal disease spent on average 1.29 more days in the hospital (7.45 vs. 6.16 days, p < 0.001) and accrued $5838 extra in hospital charges (p = 0.005). CONCLUSIONS: Perianal disease in younger patients is associated with a longer length of stay, higher hospital charges, and increased rates of both perineal and abdominal operative procedures. These data support the notion that, similar to adults, the presence of perianal disease in pediatric Crohn's patients is associated with a more severe course.

An outcome and cost analysis of anal fistula plug insertion vs endorectal advancement flap for complex anal fistulae.

AIM: The study aimed to compare the rate of success and cost of anal fistula plug (AFP) insertion and endorectal advancement flap (ERAF) for anal fistula. METHOD: Patients receiving an AFP or ERAF for a complex single fistula tract, defined as involving more than a third of the longitudinal length of of the anal sphincter, were registered in a prospective database. A regression analysis was performed of factors predicting recurrence and contributing to cost. RESULTS: Seventy-one patients (AFP 31, ERAF 40) were analysed. Twelve (39%) recurrences occurred in the AFP and 17 (43%) in the ERAF group (P = 1.00). The median length of stay was 1.23 and 2.0 days (P < 0.001), respectively, and the mean cost of treatment was €5439 ± €2629 and €7957 ± €5905 (P = 0.021), respectively. On multivariable analysis, postoperative complications, underlying inflammatory bowel disease and fistula recurring after previous treatment were independent predictors of de novo recurrence. It also showed that length of hospital stay ≤ 1 day to be the most significant independent contributor to lower cost (P = 0.023). CONCLUSION: Anal fistula plug and ERAF were equally effective in treating fistula-in-ano, but AFP has a mean cost saving of €2518 per procedure compared with ERAF. The higher cost for ERAF is due to a longer median length of stay.

Health care costs of complex perianal fistula in Crohn's disease.

AIM: To evaluate the use of health care resources and the associated costs of complex perianal Crohn's disease (CD) from the National Health System perspective. METHODS: We conducted a multicenter, retrospective, observational study in which gastroenterologists from 11 hospitals in the Community of Madrid took part. Data was collected on the direct healthcare resources (pharmacological treatments, surgical procedures, laboratory/diagnostic tests, visits to specialists and emergency departments, and hospitalizations) consumed by 97 adult patients with complex perianal CD which was active at some point between January 1, 2005, and case history review. RESULTS: We recorded 527 treatments: 73.1% pharmacological (32.3% antibiotic, 20.5% immunomodulator, 20.3% biological) and 26.9% surgical. Mean annual global cost was €8,289/patient, 75.3% (€6,242) of which was accounted for by pharmacological treatments (€13.44 antibiotics; €1,136 immunomodulators; €5,093 biological agents), 12.4% (€1,027) by hospitalizations and surgery, 7.7% (€640) by medical visits, 4.2% (€350) by laboratory/diagnostic tests, and 0.4% (€30) by emergency department visits. CONCLUSIONS: Pharmacological therapies, and in particular biological agents, are the main cost driver in complex perianal CD; costs due to surgery and hospitalizations are much lower.

To plug or not to plug: a cost-effectiveness analysis for complex anal fistula.

BACKGROUND: Complex anal fistulas are unsuitable for fistulotomy because of the risk of fecal incontinence. The anal fistula plug (AFP) has demonstrated fistula healing without sphincter division. This study aims to evaluate the cost-effectiveness of the AFP compared to the endoanal advancement flap (EAAF) as an alternative sphincter-preserving option for complex anal fistulas. METHODS: The study included 24 patients who underwent treatment for complex anal fistulas. Healing and complication rates of a prospective cohort of AFP patients (n=12) were compared to a retrospective cohort of patients who underwent EAAF (n=12). Cost data were collected after validated healthcare reporting standards. A cost-effectiveness analysis was performed, including extensive modeling of fistula healing rates. RESULTS: Both cohorts (12 AFP patients and 12 EAAF patients) had similar patient demographics and fistula characteristics. Fistula healing was achieved in 50% (5/12) of AFP patients and 33% (4/12) of EAAF patients (P=.680). Median clinical follow-up was 28 weeks for the AFP patients and 14 weeks for the EAAF patients, whereas median recurrence time was 17.6 weeks (range, 0.4-43.9) and 12.6 weeks (range, 2-34.3), respectively. Use of the AFP instead of the EAAF saved $1,588 (95% confidence interval [CI], $1,211-$1,965; P<.0001), and 1.5 hospital days per healed fistula (P=.0002). This cost-saving effect persisted and amounted to $825 (95% CI, $133-$1,517; P=.022) when the cost estimates were adjusted for the reduction in the hospital length of stay. Extensive modeling over a large range of fistula healing rates confirmed the cost-effectiveness of the AFP. CONCLUSION: The AFP is a cost-saving procedure for complex anal fistulas compared to the EAAF.

[Clinical research of thread-dragging through fistula method in treating patients with simple anorectal fistula].

OBJECTIVE: To evaluate the efficacy and safety of thread-dragging through fistula method in treating patients with simple anorectal fistula. METHODS: In this multi-centered, prospective, and randomized controlled clinical trial, 244 patients with simple low or high anorectal fistula were randomly divided into study group (with the method of thread-dragging through fistula) and control group (with the method of incision or thread-drawing). The healing time and curative rate of anorectal fistula, and the integral calculus of clinical symptom and life quality evaluations before and after treatment were all examined. The maximal anal canal squeeze pressure was measured to compare the therapeutic safety between these two groups. The health economical benefits were also assessed to determine which therapeutic method was more economical. RESULTS: The curative rate of simple low and high anorectal fistula were of no significant differences between the study group and the control group. The healing time of simple low anorectal fistula in the study group and the control group were (22.26+/-8.67) d and (31.41+/-11.39) d respectively, while the healing time of simple high anorectal fistula in the study group and the control group were (24.73+/-8.15) d and (32.20+/-12.60) d respectively, and there revealed significant differences between these two groups. Each integral calculus of clinical symptom evaluation in the study group was not obviously different from those in the control group besides the integral calculus of anal sphincter function. The integral calculus of life quality between the study group and the control group of simple low anorectal fistula had no significant differences. The integral calculus of anal sphincter function and confidence in treatment in the study group of high anorectal fistula were better than those in the control group. The hospitalization expense of the study group was remarkably lower than that of the control group. The maximal anal canal squeeze pressure in the study group after treatment was not reduced obviously as compared with that in the same group before treatment, while it was decreased significantly in the control group after treatment as compared with those in the same group before treatment and in the study group after treatment. CONCLUSION: The method of thread-dragging through fistula in treating simple low and high anorectal fistula can shorten the course of the disease, save the hospitalization expenses, improve the life quality of the patients, and protect the anal sphincter function.