Primary studies included in this systematic review

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Primary study

Unclassified

Giornale Surgery
Year 2013
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BACKGROUND: Although total abdominal colectomy has long been considered definitive treatment for fulminant ulcerative colitis refractory to medical management, the optimal timing of surgery remains controversial. Early surgical intervention may be beneficial to patients with acute ulcerative colitis. Our goal was to compare outcomes after colectomy for fulminant ulcerative colitis and to identify preoperative factors that are predictive of poor outcome. METHODS: The charts of 107 patients treated by total abdominal colectomy with ileostomy for fulminant ulcerative colitis between 2004 and 2009 were retrospectively reviewed. Twenty-nine patients sustained a major postoperative complication; 78 patients recovered uneventfully. Perioperative statistics, 30-day readmission/reoperation rates, and perioperative morbidity and mortality were compared using the Student t and Fisher exact tests and χ(2) analysis where appropriate. RESULTS: White blood cell count at admission was significantly higher among patients who developed postoperative complications, but there were no differences in patient characteristics, other acute illness measures, or disease extent. Univariate analysis revealed that patients who developed postoperative complications underwent colectomy significantly later (3.6 vs 7.4 days; P = .01) than those who recovered uneventfully. Laparoscopic colectomy took significantly longer than open surgery, but did not affect postoperative morbidity. Multivariate analysis revealed duration of preoperative medical treatment to be the only significant predictor of increased risk of postoperative morbidity. Follow-up data revealed that similar percentages of patients in both groups eventually underwent ileal pouch anal anastomosis (IPAA; 68% vs 77%; P = .5). CONCLUSION: Prolonged duration of preoperative medical treatment correlates with poor postoperative outcomes after total abdominal colectomy for fulminant ulcerative colitis. In addition, sustaining postoperative complications did not prevent patients from eventually undergoing IPAA.

Primary study

Unclassified

Giornale Annals of surgery
Year 2012
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BACKGROUND: Inflammatory bowel diseases are costly chronic gastrointestinal diseases. We aimed to determine whether immediate colectomy with ileal pouch-anal anastamosis (IPAA) after diagnosis of severe ulcerative colitis (UC) was cost-effective compared to the standard medical therapy. METHODS: We created a Markov model simulating 2 cohorts of 21-year-old patients with severe UC, following them until 100 years of age or death, comparing early colectomy with IPAA strategy to the standard medical therapy strategy. Deterministic and probabilistic analyses were performed. RESULTS: Standard medical care accrued a discounted lifetime cost of $236,370 per patient. In contrast, early colectomy with IPAA accrued a discounted lifetime cost of $147,763 per patient. Lifetime quality-adjusted life-years gained (QALY-gained) for standard medical therapy was 20.78, while QALY-gained for early colectomy with IPAA was 20.72. The resulting incremental cost-effectiveness ratio (Δcosts/ΔQALY) was approximately $1.5 million per QALY-gained. Results were robust to one-way sensitivity analyses for all variables in the model. Quality-of-life after colectomy with IPAA was the most sensitive variable impacting cost-effectiveness. A low utility value of less than 0.7 after colectomy with IPAA was necessary for the colectomy with IPAA strategy to be cost-ineffective. CONCLUSIONS: Under the appropriate clinical settings, early colectomy with IPAA after diagnosis of severe UC reduces health care expenditures and provides comparable quality of life compared to exhaustive standard medical therapy.

Primary study

Unclassified

Autori Coakley BA , Divino CM
Giornale The American surgeon
Year 2012
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Surgical-site infections (SSIs) remain a major source of morbidity after colectomy for fulminant ulcerative colitis (UC). Identifying UC patients at elevated risk of developing SSIs might improve postoperative outcomes. Our goal was to identify preoperative factors, which could predict SSI development in the postoperative UC population. The records of 59 patients treated by colectomy for fulminant UC from 2004 to 2009 were retrospectively reviewed and statistically analyzed. Few differences were observed between patients who developed postoperative complications and those who did not. Twenty patients sustained a total of 27 complications, with superficial SSIs being the single most common event. Multivariate analysis identified diabetes, white blood cell count > 15 cells/mm(3), intraoperative blood loss > 200 cc, and intraoperative blood transfusion to all be independent predictors for the development of postoperative SSIs. These four factors were all able to independently predict SSIs. Postoperative UC patients with these risk factors might benefit from heightened wound surveillance or closer follow-up.

Primary study

Unclassified

Giornale Langenbeck's archives of surgery / Deutsche Gesellschaft für Chirurgie
Year 2012
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PURPOSE: Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) for ulcerative colitis is associated with pouch-related septic complications (PRSC) in 10% of patients. This study questioned if PRSC have a negative impact on pouch function and quality of life. PATIENTS AND METHODS: One hundred thirty consecutive patients undergoing IPAA for ulcerative colitis between 1997 and 2009 were reviewed. At 1-year follow-up, patients were asked to complete questionnaires including a pouch function score (Oresland score, 0-16 points, 0 optimum) and two quality of life scores [Short Inflammatory Bowel Disease Questionnaire (SIBDQ), 1-7 points, 7 optimum; Gastrointestinal Quality of Life Index (GIQLI), 0-144 points, 144 optimum]. RESULTS: Twelve out of 130 patients (9.2%) undergoing IPAA developed PRSC. These included anastomotic dehiscence (five), pouch leakage (three, one patient had a combined leak), peripouchal abscess (three), pouch-anal fistula (one), and pouch-vaginal fistula (one). Omission of diverting ileostomy was a risk factor for PRSC (OR 4.62, CI 1.17-18.4). PRSC led to four pouch failures (33%), whereas no failure occurred in the control group (p < 0.001). Median 3 (range, 1-10) further operations were necessary until the pouch was salvaged or definitively lost. If the pouch was salvaged, functional Oresland score (8.2 ± 1.3 vs. 6.6 ± 0.5; p = 0.127), SIBDQ (5.0 ± 0.5 vs. 5.5 ± 0.1; p = 0.203), and GIQLI (95.8 ± 8.4 vs. 107.3 ± 2.6; p = 0.119) were not significantly inferior to uncomplicated controls. CONCLUSIONS: In case of PRSC, even multiple surgical approaches are worthwhile as the outcome of salvaged pouches in terms of function and quality of life is not substantially inferior to patients without septic complications.

Primary study

Unclassified

Autori Punekar YS , Hawkins N
Giornale The European journal of health economics : HEPAC : health economics in prevention and care
Year 2010
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Background: Infliximab has been shown to be efficacious in acute exacerbations of ulcerative colitis (UC). Aim: To evaluate the cost-effectiveness of infliximab treatment in patients hospitalised with acute exacerbations of UC. Methods: A decision analysis model was constructed to simulate the progression of acute UC patients treated with infliximab induction regimen over 1 year. Infliximab treatment was compared with standard care, ciclosporin and surgery using transitions derived from infliximab and ciclosporin randomised trials. Costs and outcomes were discounted at 3.5%. Intermediate outcomes of colectomy and post-surgery complications were translated into the primary effectiveness measurement, which was quality-adjusted life years (QALYs) estimated using EQ-5D. One-way and probabilistic sensitivity analyses were performed to estimate the uncertainty around the results. Results: The incremental cost effectiveness ratio (ICER) for infliximab was £19,545 per QALY compared to ciclosporin, which in turn dominated standard care. Sensitivity analysis indicated patient body weight, utility estimates and treatment effect of alternative treatment strategies to be the most important factors affecting cost-effectiveness. Conclusion: Infliximab induction regimen appears to be a cost-effective treatment option for UC patients hospitalised with an acute exacerbation. © 2009 Springer-Verlag.

Primary study

Unclassified

Giornale Surgical endoscopy
Year 2010
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PURPOSE: To evaluate laparoscopic versus open subtotal colectomy (STC) in patients with ulcerative colitis (UC) requiring urgent or emergent operative intervention. METHODS: A retrospective review was performed of 90 patients with medically refractory UC who underwent STC with end ileostomy at The Mount Sinai Medical Center from 2002 to 2007. Patients with toxic megacolon were excluded. Univariate analysis was conducted by unpaired Student t-test and chi-square test. Results are presented as mean +/- 95% confidence interval. RESULTS: Ninety patients underwent STC, 29 by laparoscopic and 61 by open approach. In patients undergoing laparoscopic versus open STC, intraoperative blood loss was decreased (130.4 +/- 38.4 vs. 201.4 +/- 43.2 ml, p < 0.05) and operative time prolonged (216.4 +/- 20.2 vs. 169.9 +/- 14.4 min, p < 0.01). In the absence of postoperative complication, hospital length of stay (4.5 +/- 0.7 vs. 6 +/- 1.3 days, p < 0.001) was shorter in laparoscopic versus open group. No mortalities occurred. Overall morbidity, 30-day readmission, and reoperation were equivalent regardless of operative approach. Wound complications were absent in the laparoscopic group compared with 21.4% in the open group (p < 0.01). Follow-up at a mean of 36 months demonstrated no difference in restoration of gastrointestinal continuity. CONCLUSION: Laparoscopic STC confers the benefits of improved cosmesis, reduced intraoperative blood loss, negligible wound complications, and shorter hospital stay. Laparoscopy is a feasible and safe alternative to open STC in patients with UC refractory to medical therapy requiring urgent or emergent operation.

Primary study

Unclassified

Giornale Gastrointestinal endoscopy
Year 2009
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BACKGROUND: Management of unifocal, flat, low-grade dysplasia (LGD) in ulcerative colitis (UC) remains controversial. OBJECTIVE: To compare the relative costs and effectiveness of immediate colectomy and enhanced colonoscopic surveillance for the management of LGD. DESIGN AND SETTING: Medical decision analysis by using state-transition Markov models. Transition probabilities and health utilities were derived from the literature, and costs were derived from national hospital data sets and Medicare and/or Medicaid reimbursement schedules. PATIENTS: Two simulated cohorts of 10,000 patients with longstanding UC who were newly diagnosed with unifocal, flat LGD on initial surveillance colonoscopy. INTERVENTIONS: Immediate colectomy or enhanced surveillance (repeated colonoscopy at 3, 6, and 12 months, and then annually). MAIN OUTCOME MEASUREMENTS: Costs, quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios. RESULTS: Immediate colectomy dominated over enhanced surveillance and yielded higher QALYs (20.1 vs 19.9 years) and lower costs ($75,900 vs $83,900). These findings were robust to variations in model parameters, with immediate colectomy remaining dominant in 90% of simulations in sensitivity analysis. Varying postcolectomy health utility outside the range in the probabilistic sensitivity analysis rendered enhanced surveillance cost effective. When the health utility was below 0.77, the incremental cost-effectiveness ratio was $50,000 per QALY. LIMITATIONS: Data based on observational studies and analyses rely on model assumptions. CONCLUSIONS: Our analysis showed that immediate colectomy was preferable to enhanced surveillance. Health preference toward the postcolectomy state is, however, an influential factor. This decision analysis model provides a conceptual framework for physicians and patients to understand the relative benefits and costs of both interventions.

Primary study

Unclassified

Giornale Alimentary pharmacology & therapeutics
Year 2008
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BACKGROUND: Infliximab (IFX) has been shown to be efficacious in moderate-severe ulcerative colitis (UC). Aim To evaluate the cost-effectiveness of a scheduled maintenance treatment (SMT) with IFX in moderate-severe UC patients. METHODS: A Markov model was constructed to simulate the progression of a cohort of moderate-severe UC patients treated with IFX (5 mg/kg) SMT. Transitions were estimated from two phase III trials of IFX (ACT I and ACT II). Standard care, comprising immunomodulators and/or corticosteroids was used as a comparator. Two separate treatment strategies were evaluated - continued treatment in IFX responders and continued treatment in IFX patients achieving remission. The dose of IFX was estimated for a 73 kg typical UC patient in the UK. The results were calculated over 10 years using a discount rate of 3.5% for costs and outcomes. The outcome measure was quality-adjusted life years (QALYs) estimated using EQ-5D. Sensitivity analyses explored the uncertainty around the results. RESULTS: The incremental cost effectiveness ratio (ICER) for IFX was 27,424 pounds in the responder strategy and 19,696 pounds in the remission strategy at 10 years. In sensitivity analysis, the ICER for IFX in the responder strategy ranged from 21,066 pounds to 86,322 pounds and in the remission strategy ranged from 14,728 pounds to 46,765 pounds. The model time horizon and patient body weight were important factors affecting results. CONCLUSION: Eight-week SMT with IFX appears to be a cost-effective treatment option for adult patients suffering from moderate to severe UC.

Primary study

Unclassified

Giornale Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract
Year 2008
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PURPOSE: Open ileal pouch surgery leads to high rates of adhesive small-bowel obstruction (SBO). A laparoscopic approach may reduce these complications. We aimed to review the incidence of adhesive SBO-related complications after open pouch surgery and to model the potential financial impact of a laparoscopic approach purely as an adhesion prevention strategy. MATERIALS AND METHODS: We reviewed cases of open ileal pouch patients kept on a database and examined annually. Case notes were studied for episodes of adhesive SBO requiring admission or reoperation. Similar parameters were studied in a small series undergoing laparoscopic pouch surgery. The financial burden of the open access complications was estimated and potential financial impact of a laparoscopic approach modeled. RESULTS: Two hundred seventy-six patients were followed up after open surgery (median, 6.3; range, 0.2-20.1 years). There were 76 (28%) readmissions (median length of stay, 7.4 days) in 53 patients (19%) and 28 (10%) reoperations (43% within 1 year). Laparoscopic patients required less adhesiolysis at second-stage surgery (0% vs 36%, p < 0.0001) and had less SBO episodes within 12 months of surgery (0% vs 14%, p < 0.0001) than open patients. Modeling a laparoscopic approach cost $1,450 and saved $3,282, thus netting $1,832 per pouch constructed. CONCLUSION: Open ileal pouch surgery results in significant cumulative long-term access-related complications, particularly adhesions. These impose a large medical burden on patients and financial burden on health-care systems, all of which may be recouped by a laparoscopic approach, despite higher theater costs.

Primary study

Unclassified

Autori Aberg H , Påhlman L , Karlbom U
Giornale International journal of colorectal disease
Year 2007
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BACKGROUND AND AIMS: The reported risk of small-bowel obstruction (SBO) after major abdominal surgery varies. The aim of this study was to study frequency and risk factors of SBO after ileal pouch-anal anastomosis for ulcerative colitis. METHODS: Review of the medical records of 188 patients operated with restorative proctocolectomy between 1985 and 1997. All admissions to the hospital were registered and symptoms and X-ray findings consistent with ileus were analysed in relation to preoperative and operative data. RESULTS: SBO was the dominating cause of hospitalization. Forty-eight patients (25.5%) had developed SBO after a median of 76 (range 6-196) months of follow-up, of whom 26 were operated on. The cause of obstruction was adhesion in all but one patient. Early obstruction events were common and accounted for 27% of all operations. Twenty-five of 26 patients who were operated on had a diverting loop-ileostomy compared to 111/162 in the not-operated-on group (p < 0.01). In total, 696 days were spent at the hospital because of SBO. CONCLUSION: SBO is common following pouch surgery and is the dominating cause of hospitalization postoperatively. About 25% of patients developed SBO and half of them needed surgery. The use of a diverting loop-ileostomy was related to an increased risk of surgery for SBO.