Risk and Economic Burden of Peristomal Skin Complications Following Ostomy Surgery.

PURPOSE: The purpose of this study was to examine the incidence and economic burden of peristomal skin complications (PSCs) following ostomy surgery. DESIGN: Retrospective cohort study based on electronic health records and administrative data stores at a large US integrated healthcare system. SUBJECTS AND SETTINGS: The sample comprised 168 patients who underwent colostomy (ICD-9-CM 46.1X) (n = 108), ileostomy (46.2X) (n = 40), cutaneous ureteroileostomy (56.5X), or other external urinary diversion (56.6X) (n = 20) between January 1, 2012, and December 31, 2014. The study setting was an integrated health services organization that serves more than 2 million persons in the northeastern United States. METHODS: We scanned electronic health records of all study subjects to identify those with evidence of PSCs within 90 days of ostomy surgery and then examined healthcare utilization and costs over 120 days, beginning with date of surgery, among patients with and without evidence of PSCs. Testing for differences in continuous measures between the 3 ostomy groups was based on one-way analysis of variance; testing for differences in such measures between the PSC and non-PSC groups was based on a t statistic, and the χ statistic was used to test for differences in categorical measures. RESULTS: Sixty-one subjects (36.3%) had evidence of PSCs within 90 days of ostomy surgery (ileostomy, 47.5%; colostomy, 36.1%; urinary diversion, 15.0%; P < .05 for differences between groups). Among patients with evidence of PSCs, the mean (SD) time from surgery to first notation of this complication was 26.4 (19.0) days; it was 24.1 (13.2) days for ileostomy, 27.2 (21.1) days for colostomy, and 31.7 (25.7) days for urinary diversion (P = .752). Patients with PSCs were more likely to be readmitted to hospital by day 120 (55.7% vs 35.5% for those without PSCs; P = .011). The mean length of stay for patients readmitted to hospital was 11.0 days for those with PSCs and 6.8 days for those without PSCs (P = .111). The mean total healthcare cost over 120 days was $58,329 for patients with evidence of PSCs and $50,298 for those without evidence of PSCs (P = .251). CONCLUSIONS: Approximately one-third of ostomy patients developed PSCs within 90 days of their surgery. Peristomal skin complications are associated with a greater likelihood of hospital readmission. Our findings corroborate results of earlier studies.

Early versus conventional stoma closure following bowel surgery: A randomized controlled trial.

Background/Aim: To compare early stoma closure with conventional stoma closure following defunctioning diversion stoma surgery with respect to the frequency of complications, health-related quality of life (QoL), and length of hospitalization (LoH). Patients and Methods: This study was designed as a prospective parallel-arm randomized controlled trial. Patients who underwent temporary stoma following bowel surgery between February 2014 and November 2015 were included. The rate of complications (medical and surgical) following early and conventional stoma closure was assessed. Health-related QoL and LoH were also measured. Results: One hundred patients were included, with 50 cases in each group. Postoperative complications including laparostoma (6% vs. 2%;P = 0.307), wound infection (32% vs. 18%; P = 0.106), intra-abdominal collection (14% vs. 18%; P = 0.585), anastomotic leak (4%vs. 8%;P = 0.400), and medical complications were comparable (22% vs. 32%;P = 0.257). The length of hospital stay, overall mortality and morbidity (64% vs. 44%; P = 0.05) were similar across the two groups. There was a significant reduction in the cost towards stoma care (96% vs. 2%; P = 0.001) in the early stoma closure group. Patients in the early stoma closure group also had a significantly better QoL. Conclusion: Early stoma closure does not carry an increased risk of postoperative complications, reduces cost towards stoma care, and leads to better a QoL.

Cost-effectiveness of a Ceramide-Infused Skin Barrier Versus a Standard Barrier: Findings From a Long-Term Cost-effectiveness Analysis.

PURPOSE: To assess the cost-effectiveness of a ceramide-infused skin barrier (CIB) versus other skin barriers (standard of care) among patients who have undergone ostomy creation. DESIGN: Cost-effectiveness analysis, based on a decision-analytic model that was estimated using data from the ADVOCATE (A Study Determining Variances in Ostomy Skin Conditions And The Economic Impact) trial, which investigated stoma-related healthcare costs over 12 weeks among patients who recently underwent fecal ostomy, and from other sources. SUBJECTS AND SETTING: Analysis was based on a hypothetical cohort of 1000 patients who recently underwent fecal ostomy; over a 1-year period, 500 patients were assumed to use CIB and 500 were assumed to use standard of care. METHODS: We adapted a previous economic model to estimate expected 1-year costs and outcomes among persons with a new ostomy assumed to use CIB versus standard of care. Outcomes of interest included peristomal skin complications (PSCs) (up to 2 during the 1-year period of interest) and quality-adjusted life days (QALDs); QALDs vary from 1, indicating a day of perfect health to 0, indicating a day with the lowest possible health (deceased). Subjects were assigned QALDs on a daily basis, with the value of the QALD on any given day based on whether the patient was experiencing a PSC. Costs included those related to skin barriers, ostomy accessories, and care of PSCs. The incremental cost-effectiveness of CIB versus standard of care was estimated as the incremental cost per PSC averted and QALD gained, respectively; net monetary benefit of CIB was also estimated. All analyses were run using the perspective of an Australian payer. RESULTS: On a per-patient basis, use of CIB was expected over a 1-year period to result in 0.16 fewer PSCs, an additional 0.35 QALDs, and a savings of A$180 (Australian dollars, US $137) in healthcare costs all versus standard of care. Management with CIB provided a net monetary benefit (calculated as the product of maximum willingness to pay for 1 QALD times additional QALDs with CIB less the incremental cost of CIB) of A$228 (US $174). Probabilistic sensitivity analysis was also completed; it revealed that 97% of model runs resulted in fewer expected PSCs with CIB; 92% of these runs resulted in lower expected costs with CIB. CONCLUSIONS: Findings suggest that the CIB is a cost-effective skin barrier for persons living with an ostomy.

Stoma care in a time of financial pressures: can we cut the costs?

Andrew Bird, Lead Stoma Care Nurse Specialist, Colorectal and Stoma Care, Surgery Division, Queen's Medical Centre Campus, Nottingham University Hospitals NHS Trust, Andrew.Bird@nuh.nhs.uk.

Cost analysis of laparoscopic lavage compared with sigmoid resection for perforated diverticulitis in the Ladies trial.

BACKGROUND: Laparoscopic peritoneal lavage is an alternative to sigmoid resection in selected patients presenting with purulent peritonitis from perforated diverticulitis. Although recent trials have lacked superiority for lavage in terms of morbidity, mortality was not compromised, and beneficial secondary outcomes were shown. These included shorter duration of surgery, less stoma formation and less surgical reintervention (including stoma reversal) for laparoscopic lavage versus sigmoid resection respectively. The cost analysis of laparoscopic lavage for perforated diverticulitis in the Ladies RCT was assessed in the present study. METHODS: This study involved an economic evaluation of the randomized LOLA (LaparOscopic LAvage) arm of the Ladies trial (comparing laparoscopic lavage with sigmoid resection in patients with purulent peritonitis due to perforated diverticulitis). The actual resource use per individual patient was documented prospectively and analysed (according to intention-to-treat) for up to 1 year after randomization. RESULTS: Eighty-eight patients were randomized to either laparoscopic lavage (46) or sigmoid resection (42). The total medical costs for lavage were lower (mean difference € - 3512, 95 per cent bias-corrected and accelerated c.i. -16 020 to 8149). Surgical reintervention increased costs in the lavage group, whereas stoma reversal increased costs in the sigmoid resection group. Differences in favour of laparoscopy were robust when costs were varied by ±20 per cent in a sensitivity analysis (mean cost difference € - 2509 to -4438). CONCLUSION: Laparoscopic lavage for perforated diverticulitis is more cost-effective than sigmoid resection.

To explore preferences and willingness to pay for attributes regarding stoma appliances amongst patients in the UK, France and Germany.

OBJECTIVES: To explore patient preferences regarding stoma appliances in the UK, France and Germany and to estimate willingness to pay (WTP) for attributes of stoma appliances. RESEARCH DESIGN AND METHODS: A discrete choice (DCE) survey was developed based on published literature, attributes of current available appliances and qualitative interviews with patients from the UK (N = 3), France (N = 2) and Germany (N = 2). Members from a patient panel in the UK, France and Germany were asked to participate in the DCE survey and to fill out two quality of life (QoL) questionnaires. Data were analyzed using the conditional logit model whereby the coefficients obtained from the model provided an estimate of the (log) odds ratios (ORs) of preference for attributes. WTP was estimated for each level of a given identified attribute. RESULTS: Seven key attributes were identified for the DCE survey: comfort and elastic flexibility, skin problems, early detection of leakage, leakage, filter performance, service/help after hospital discharge and out-of-pocket cost. A total of 415 participants (166 patients in UK, 99 in France, and 150 in Germany) completed the questionnaires. All attributes were significant predictors of choice. The two most important drivers of preference were the attributes comfort and elastic flexibility and skin problems which resulted in high WTP values. Appliances which were able to detect episodes of leakage were also of high importance to participants' appliances. CONCLUSIONS: The results show the importance of different attributes of stoma appliances for patients. Improving comfort and elastic flexibility, and risk of skin problems were the most important aspects of appliances. The WTP values indicate the value people place on improvement in each attribute of appliances.

[Single port laparoscopic colostomy using the glove technique]. / Colostomía laparoscópica por puerto único con técnica de guante.

The single port surgery with glove technique is a novel process, suitable to the present day economic and technological moment. Colostomies are surgical interventions suitable to its application. We describe the surgical method and outcome of patients who underwent colostomy by single port glove technique within the years 2011 and 2012, in two hospitals in Asturias, Spain. We carried out six sigmoid colostomies. Four patients had tumoral pathology, another a perineal necrotizing fasciitis, and the sixth, a patient with Crohn's disease and complex perianal fistulas. The average age of the patients, four men and two women, was 54 years (range 42-67 years). The average intervention time was 42 minutes (range 30-65 minutes). There were no complications during the surgery or in the postoperative period. In our facilities material expenditure was reduced to half as regards other conventional single port devices. The glove technique represents the most economic and least invasive approach for the surgical procedure of stomas, in our experience considered a simple, safe and easily reproducible technique.

Colostomía laparoscópica por puerto único con técnica de guante / Single port laparoscopic colostomy using the glove technique

La cirugía por puerto único con técnica de guante (glove port) es un abordaje adecuado al momento económico y tecnológico que vivimos. Entre las intervenciones susceptibles de su aplicación está la realización de colostomías. Describimos la técnica quirúrgica y resultados de los pacientes a los que se realizó colostomía por puerto único con técnica de guante, a lo largo de los años 2011 y 2012, en dos hospitales de Asturias, España. Realizamos seis colostomías sigmoideas. Cuatro pacientes presentaban enfermedad tumoral, otro caso fue por una fascitis necrosante perineal, y el sexto un paciente con enfermedad de Crohn y fístulas perianales complejas. La edad media de los pacientes, cuatro hombres y dos mujeres, fue de 54 años (rango 42-67 años). El tiempo medio de intervención fue de 42 minutos (rango 30-65 minutos). No hubo complicaciones durante la cirugía ni en el postoperatorio. En nuestro medio, el gasto en material se redujo a la mitad con respecto a otros dispositivos convencionales de puerto único. La técnica de guante representa el abordaje por puerto único más económico y mínimamente invasivo para la realización de estomas, siendo en nuestra experiencia una técnica sencilla, segura y fácilmente reproducible.

The single port surgery with glove technique is a novel process, suitable to the present day economic and technological moment .Colostomies are surgical interventions suitable to its application. We describe the surgical method and outcome of patients who underwent colostomy by single port glove technique within the years 2011 and 2012, in two hospitals in Asturias, Spain. We carried out six sigmoid colostomies. Four patients had tumoral pathology, another a perineal necrotizing fasciitis, and the sixth, a patient with Crohn's disease and complex peri-anal fistulas. The average age of the patients, four men and two women, was 54 years (range 42-67 years). The average intervention time was 42 minutes (range 30-65 minutes). There were no complications during the surgery or in the postoperative period. In our facilities material expenditure was reduced to half as regards other conventional single port devices. The glove technique represents the most economic and least invasive approach for the surgical procedure of stomas, in our experience considered a simple, safe and easily reproducible technique.

Patient education after stoma creation may reduce health-care costs.

INTRODUCTION: Researchers are urged to include health-economic assessments when exploring the benefits and drawbacks of a new treatment. The aim of the study was to assess the costs associated with the establishment of a new patient education programme for patients with a stoma. MATERIAL AND METHODS: Following a previous case-control study that explored the effect of patient education for stoma patients, we set out to examine the costs related to such a patient education programme. The primary outcome was disease-specific health-related quality of life measured with the Ostomy Adjustment Scale six months after surgery. The secondary outcome was generic health-related quality of life measured with Short Form (SF)-36. In this secondary analysis, we calculated direct health-care costs for the first six months post-operatively from the perspective of the health-care system, including costs related to the hospital as well as primary health care. RESULTS: The overall cost related to establishing a patient education programme showed no significant increase in the overall average costs. However, we found a significant reduction in costs related to unplanned readmissions (p = 0.01) as well as a reduction in visits to the general practitioner (p = 0.05). CONCLUSION: Establishing a patient education programme - which increased quality of life - will probably not increase the overall costs associated with the patient course. FUNDING: The study received financial support from Søster Inge Marie Dahlgaards Fond, Diakonissestiftelsen, Denmark, and from Aase and Ejnar Danielsens Foundation, Denmark. TRIAL REGISTRATION: NCT01154725.

Life after stoma creation.

BACKGROUND: Stoma creation is a surgical operation where the surgeon makes an artificial opening on the abdomen from where the bowel is taken out. It is a radical treatment with permanent physical signs of bodily change. In general, it leads to loss of a central and personal physical function, as well as an alteration in the bodily design. Research in the field may provide additional information about central elements when adapting to life with a stoma. There are currently no studies that adequately focus on the relationship between health-related quality of life and stoma construction in a Danish context, neither for temporary or permanent construction, nor in relation to the importance of stoma handling. PURPOSE: The overall objective of the study was to investigate health-related quality of life related to stoma creation and patient education. Methodologically, the project was implemented as a mixed methods study in which qualitative interview studies and two systematic literature reviews identified interventions, which were subsequently tested in a clinical case/control study. Finally the case/control study was made subject to an economic analysis. The project is based on 6 papers reporting the results. ARTICLE 1: Impact of a temporary stoma on patients everyday-lives: feelings of uncertainty while waiting for closure of the stoma. The study included 7 participants who were interviewed in focus groups. The results indicated that patients experienced a high degree of uncertainty in connection with the stoma being temporary. At the same time, participants had a strong need to control both their physical appearance and their changed bodily functions. Participants opted for education programs involving teachers with a stoma. ARTICLE 2: Learning to live with a Permanent Intestinal Ostomy: Impact on everyday life and Educational Needs. The study included 15 participants who were interviewed in groups related to whether they were treated for cancer or non-cancer. The results showed that participants often experienced the stoma as a taboo, and emotions related to stigma were identified. In addition, participants were influenced by the stoma in various ways, and the stoma imposed some restrictions on the participants. Participants pointed at group-based education, as well as the involvement of teachers who had a stoma. ARTICLE 3: Spouses of patients with a stoma lack information and support and are restricted in their social and sexual life: a systematic review. The study included 6 articles based on quantitative and qualitative data showing that spouses were affected in several ways by the construction of the stoma. The results pointed at spouses not being informed and supported sufficiently by neither enterostoma therapists or surgeons. ARTICLE 4: Patient education has a positive effect in patients with a stoma - a systematic review The study included 7 studies, all with quantitative results. They showed that patient education had a positive impact in several areas including shorter hospital stay, less time until proficiency in stoma management is reached, an increase in quality of life, increased knowledge about the stoma, and increased self-efficacy. ARTICLE 5: Health-related quality of life increases when patients with a stoma attend patient education - a case/control study. The study included 50 participants shortly after stoma creation. The results showed that the disease-specific quality of life was significantly increased in the intervention group, while generic health-related quality of life was positively affected in different dimensions in both groups. ARTICLE 6: Decreased costs with patient education after stoma creation. The study was an economic analysis based on participants in Article 5. The results indicated that there were fewer unplanned re-admissions related to the stoma, and that patients in the intervention group did not visit the general practitioner as much as patients in the control group. Furthermore, we found that the average cost per patient did not increase when establishing a patient education program. CONCLUSION: The thesis concludes that patient education has a positive impact on patients' quality of life, and that costs are reduced. At the same time, it is concluded that living with a stoma is a complex situation, which also involves spouses and close relatives, and that patient education must be based on multiple interventions that are not all explored in this project.

Cost measurement in economic evaluations of health care: whom to ask?

PURPOSES: The purposes of this study were 1) to investigate the feasibility of using providers' administrative systems for the assessment of healthcare utilization in economic evaluations performed alongside multicenter studies, 2) to assess the convergent validity of patients' and providers' reports of care, and 3) to investigate whether differences between providers' and patients' reports are related to age, gender, health, recall period, and volumes of care. METHODS: Data were obtained as part of a cost-utility analysis alongside a multicenter clinical trial in patients with rectal cancer. For a sample of 179 patients from 49 hospitals, data on hospitalizations, outpatient visits, medications, and care products during the first year after treatment were obtained from the patients by questionnaire or diary. For all patients, hospitals were contacted for information on hospitalizations and outpatient visits. For a subsample of 94 patients, 86 pharmacists and 10 suppliers of stoma care products were contacted for information on medications and care products. RESULTS: Response by providers of care was high, ranging from 84% to 100%. With respect to hospital days and outpatient visits, we found no significant differences between patients' and providers' reports. For medications and care products, agreement was lower, with providers reporting up to 2 times more product types and costs than patients. Providers failed to report 20% to 25% of all products, whereas patients failed to report 50% to 60% of all products. CONCLUSIONS: Patients' reports seem as valid as providers' reports for hospital days and outpatient visits. For medications and care products, we recommend the use of reports from providers of care, whenever feasible, because they much less underestimate volumes and costs than patients.

Cost-effectiveness of defunctioning stomas in low anterior resections for rectal cancer: a call for benchmarking.

HYPOTHESIS: Anastomotic leakage is the most important cost driver in patients who undergo low anterior resection (LAR) for rectal cancer. Creating defunctioning stomas to protect colorectal anastomoses may also have a major effect on the overall costs. Unselected creation of defunctioning stomas in most of these patients may be associated with higher overall costs compared with a program that has a low rate of defunctioning stomas and an acceptable anastomotic leakage rate. DESIGN: Cost-effectiveness analysis. SETTING: Secondary referral center. PATIENTS: Performing a cost analysis from the viewpoint of a hospital provider, we reviewed data of 70 consecutive patients who underwent LARs with (n = 19) or without (n = 51) a defunctioning colostomy. A scenario analysis was performed using data derived from the medical literature to assess a plausible range of leakage and stoma rates. MAIN OUTCOME MEASURE: Costs per treatment option and incremental cost-effectiveness ratio according to various treatment scenarios. RESULTS: Performing an LAR without a stoma and no anastomotic leakage is associated with significantly lowest costs (8.400 euro; P<.001) compared with patients with a stoma (13.985 euro) and patients with anastomotic leakage (42.250 euro). The most important cost drivers were anastomotic leakages and defunctioning stomas. A leakage rate of 16.5% in patients without a stoma would be necessary to balance the overall costs of patients with stomas. The incremental cost-effectiveness ratio would be 158.705 euro and 60.915 euro per leak, respectively, avoided in patients with defunctioning stomas assuming a leakage rate lower than 3% and 6%, respectively, in patients who did not undergo a colostomy. A 1-way sensitivity analysis revealed that duration and costs of intensive care unit care were the only factors that may considerably alter our results. CONCLUSIONS: A suggested benchmark for an LAR should be a rate of 10% or less for defunctioning stomas and anastomatic leaks; that would limit the overall costs to 12,000 euro per patient treated. Against the background of a lack of universally valid criteria for the creation of defunctioning stomas, our aim should be to reduce the rate of defunctioning stomas because of their major effect on the overall costs especially in programs with a lower leakage rate. Higher leakage rates despite higher stoma rates depend more on the skill of the surgeon than on the characteristics of the patient and higher leakage should lead to a change in surgical technique strategy.

The stoma appliances market in five European countries: a comparative analysis.

This comparative exercise analysed the domestic market for stoma appliances in five European countries--Denmark, France, Germany, Italy and the United Kingdom. National legislation, prescription procedures, delivery modalities and the market were investigated in each country. The analysis involved reviewing national and international literature on stoma appliances and interviewing a selected expert panel of market operators in each country comprising at least one health authority representative, one distributor of medical devices and one manufacturer. No specific relationship was found between the health care system framework and the stoma market, except for a greater inclination towards home care in national health services. All five countries reimburse stoma bags, but the distribution of these appliances varies widely, ranging from Denmark, where home delivery is mandatory, to Italy, where any channel can be used. The comparative analysis underlined two important features of the stoma bag market: the discretion of enterostomists in directing patients towards a specific brand of bags, and the patients' high brand loyalty. Despite that, the analysis did not identify any single country that could be considered a benchmark for stoma bag regulation. Each country deals with stoma appliances in different ways, making this a very fragmented market.