Nonocclusive mesenteric infarction after cardiac surgery: potential biomarkers.

BACKGROUND: Nonocclusive mesenteric ischemia can cause intestinal infarction but the diagnosis is challenging. This prospective study evaluated three plasma biomarkers of intestinal infarction after cardiac surgery. MATERIALS AND METHODS: Patients were recruited after cardiac surgery if they required laparotomy (with or without intestinal resection) for suspected nonocclusive mesenteric ischemia. Plasma levels of D-lactate, intestinal fatty acid-binding protein (i-FABP), and smooth muscle actin (SMA) before laparotomy were measured. RESULTS: Twenty patients were recruited (68 ± 9 y, EuroSCORE: 8.7 ± 2.8, mortality 70%). A positive laparotomy (n = 13) was associated with no change in D-lactate (P = 0.95), decreased i-FABP (P = 0.007), and increased SMA (P = 0.01). All patients with high SMA had a positive laparotomy. A subgroup analysis was undertaken in the eight patients who required multiple laparotomies. D-lactate increased between the two laparotomies in nonsurvivors (n = 4). Plasma i-FABP (P = 0.008) and SMA (P = 0.036) significantly decreased after the bowel resection, regardless of survival outcome. CONCLUSIONS: None of the biomarkers were accurate enough to reliably diagnose intestinal infarction. However, all patients with high values of SMA developed intestinal infarction, thus warranting further investigation. An increasing D-lactate after intestinal resection suggests impending death.

Effect of Banded Roux-en-Y Gastric Bypass Versus Sleeve Gastrectomy on Diabetes Remission at 5 Years Among Patients With Obesity and Type 2 Diabetes: A Blinded Randomized Clinical Trial.

OBJECTIVE: To determine whether silastic ring laparoscopic Roux-en-Y gastric bypass (SR-LRYGB) or laparoscopic sleeve gastrectomy (LSG) produces superior diabetes remission at 5 years. RESEARCH DESIGN AND METHODS: In a single-center, double-blind trial, 114 adults with type 2 diabetes and BMI 35-65 kg/m2 were randomly assigned to SR-LRYGB or LSG (1:1; stratified by age-group, BMI group, ethnicity, diabetes duration, and insulin therapy) using a web-based service. Diabetes and other metabolic medications were adjusted according to a prespecified protocol. The primary outcome was diabetes remission assessed at 5 years, defined by HbA1c <6% (42 mmol/mol) without glucose-lowering medications. Secondary outcomes included changes in weight, cardiometabolic risk factors, quality of life, and adverse events. RESULTS: Diabetes remission after SR-LRYGB versus LSG occurred in 25 (47%) of 53 vs. 18 (33%) of 55 patients (adjusted odds ratios 4.5 [95% CI 1.6, 15.5; P = 0.009] and 4.2 [1.3, 13.4; P = 0.015] in the intention-to-treat analysis). Percent body weight loss was greater after SR-LRYGB than after LSG (absolute difference 10.7%; 95% CI 7.3, 14.0; P < 0.001). Improvements in cardiometabolic risk factors were similar, but HDL cholesterol increased more after SR-LRYGB. Early and late complications were similar in both groups. General health and physical functioning improved after both types of surgery, with greater improvement in physical functioning after SR-LRYGB. People of Maori or Pacific ethnicity (26%) had lower incidence of diabetes remission than those of New Zealand European or other ethnicities (2 of 25 vs. 41 of 83; P < 0.001). CONCLUSIONS: SR-LRYGB provided superior diabetes remission and weight loss compared with LSG at 5 years, with similar low risks of complications.

Systematic review and pooled estimates for the diagnostic accuracy of serological markers for intestinal ischemia.

BACKGROUND: Intestinal ischemia is a potentially catastrophic abdominal emergency that presents a significant diagnostic challenge in the critical care setting. We performed a systematic review of the literature to define the diagnostic accuracy of serological markers of intestinal ischemia. METHODS: Observational studies on the performance of markers of intestinal ischemia were identified within the MEDLINE and EMBASE electronic databases. All studies from which it was possible to derive true positive, false positive, false negative, and true negative results were included. A random-effects model was used to calculate the pooled estimates of diagnostic accuracy. RESULTS: A total of 20 articles examining 18 different serological markers were identified that met the inclusion criteria. The global measures of test performance (diagnostic odds ratio and area under the summary receiver operating characteristic curve) for markers investigated in three or more studies were D-lactate (10.75 and 0.86, respectively), glutathione S-transferase (GST; 8.82 and 0.87, respectively), intestinal fatty-acid binding protein (i-FABP; 7.62 and 0.78, respectively), and D-dimer (5.77 and 0.53, respectively). CONCLUSIONS: The performance of the currently available serological markers is suboptimal for routine clinical use, but novel markers of intestinal ischemia such as D-lactate, GST, and i-FABP may offer improved diagnostic accuracy. The early diagnosis of intestinal ischemia remains a challenge, and further research is required to identify improved serological markers and to demonstrate their clinical utility in the individual patient.

Laparoscopic Sleeve Gastrectomy Versus Banded Roux-en-Y Gastric Bypass for Diabetes and Obesity: a Prospective Randomised Double-Blind Trial.

BACKGROUND: There are very few randomised, blinded trials comparing laparoscopic sleeve gastrectomy (LSG) versus laparoscopic Roux-en-Y gastric bypass (LRYGB) in achieving remission of type 2 diabetes (T2D), particularly silastic ring (SR)-LRYGB. We compared the effectiveness of (LSG) versus SR-LRYGB among patients with T2D and morbid obesity. METHODS: Prospective, randomised, parallel, 2-arm, blinded clinical trial conducted in a single Auckland (New Zealand) centre. Eligible patients aged 20-55 years, T2D of at least 6 months duration and BMI 35-65 kg/m2 were randomised 1:1 to LSG (n = 58) or SR-LRYGB (n = 56) using random number codes disclosed after anaesthesia induction. Primary outcome was T2D remission defined by different HbA1c thresholds at 1 year. Secondary outcomes included weight loss, quality of life, anxiety and depressive symptoms, post-operative complications and mortality. RESULTS: Mean ± standard deviation (SD) pre-operative BMI was 42.5 ± 6.2 kg/m2, HbA1c 63 ± 16 mmol/mol (30% insulin-treated, 28% had diabetes duration over 10 years). Proportions achieving HbA1c ≤ 38 mmol/mol, < 42 mmol/mol, < 48 mmol/mol and < 53 mmol/mol without diabetes medication at 1 year in SR-LRYGB vs LSG were 38 vs 43% (p = 0.56), 52 vs 49% (p = 0.85), 75 vs 72% (p = 0.83) and 80 vs 77% (p = 0.82), respectively. Mean ± SD % total weight loss at 1 year was greater after SR-LRYGB than LSG: 32.2 ± 7.7 vs 27.1 ± 7.5%, respectively (p < 0.001). Gastrointestinal complications were more frequent after SR-LRYGB (including 3 ulcers, 1 anastomotic leak, 1 abdominal bleeding). Quality of life and depression symptoms improved significantly in both groups. CONCLUSION: Despite significantly greater weight loss after SR-LRYGB, there was similar T2D remission and psychosocial improvement after LSG and SR-LRYGB at 1 year. TRIAL REGISTRATION: Prospectively registered at Australia and New Zealand Clinical Trials Register (ACTRN 12611000751976) and retrospectively registered at Clinical Trials (NCT1486680).

Costs of bariatric surgery in a randomised control trial (RCT) comparing Roux en Y gastric bypass vs sleeve gastrectomy in morbidly obese diabetic patients.

AIM: To provide a longitudinal analysis of the direct healthcare costs of providing laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery service in the context of a randomised control trial (RCT) of obese patients with type 2 diabetes in Waitemata District Health Board, Auckland, New Zealand. METHODS: The Waitemata District Health Board costing system was used to calculate costs in New Zealand Dollars (NZD) associated with all pre- and post-operative hospital clinic visits, peri-operative care, hospitalisations and medication costs up to one year after bariatric surgery. Healthcare costs of medications, laboratory investigations and hospital clinic visits for one year prior to enrolment into the RCT were also calculated. RESULTS: One hundred and fourteen patients were randomised to undergo laparoscopic sleeve gastrectomy (LSG, n=58) or laparoscopic Roux en Y gastric bypass (LRYGB, n=56). Total costs one year pre-enrolment was $203,926 for all patients (mean $1,789 per patient). Total cost of surgery was $1,208,005 (mean $9,131 per LSG patient and mean $12,456 per LRYGB patient). Total cost one year post-operatively was $542,656 (mean $4,760 per patient). The total medication cost reduced from $118,993.72(mean $1,044 per patient) to $31,304.93 (mean $274.60 per patient), p<0.005. The largest cost reduction was seen with annual diabetic medications reducing from $110,115.78(mean $965.93 per patient) to $7,237.85 (mean $63.48 per patient), p<0.005. CONCLUSIONS: Among patients with type 2 diabetes and morbid obesity undergoing LSG and LRYGB, health service costs were greater in the year after surgery than in the year before, although prescription costs were lower post-operatively. There was no significant difference in reduction in prescription cost by surgical procedure at 12 months. However, the LRYGB surgery was more expensive than LSG, primarily because of the longer operative time required.

Sleeve gastrectomy versus Roux-en-Y gastric bypass for type 2 diabetes and morbid obesity: double-blind randomised clinical trial protocol.

INTRODUCTION: Type 2 diabetes (T2D) in association with obesity is an increasing disease burden. Bariatric surgery is the only effective therapy for achieving remission of T2D among those with morbid obesity. It is unclear which of the two most commonly performed types of bariatric surgery, laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB), is most effective for obese patients with T2D. The primary objective of this study is to determine whether LSG or LRYGB is more effective in achieving HbA1c<6% (<42 mmol/mol) without the use of diabetes medication at 5 years. METHODS AND ANALYSIS: Single-centre, double-blind (assessor and patient), parallel, randomised clinical trial (RCT) conducted in New Zealand, targeting 106 patients. Eligibility criteria include age 20-55 years, T2D of at least 6 months duration and body mass index 35-65 kg/m(2) for at least 5 years. Randomisation 1:1 to LSG or LRYGB, used random number codes disclosed to the operating surgeon after induction of anaesthesia. A standard medication adjustment schedule will be used during postoperative metabolic assessments. Secondary outcomes include proportions achieving HbA1c<5.7% (39 mmol/mol) or HbA1c<6.5% (48 mmol/mol) without the use of diabetes medication, comparative weight loss, obesity-related comorbidity, operative complications, revision rate, mortality, quality of life, anxiety and depression scores. Exploratory outcomes include changes in satiety, gut hormone and gut microbiota to gain underlying mechanistic insights into T2D remission. ETHICS AND DISSEMINATION: Ethics approval was obtained from the New Zealand regional ethics committee (NZ93405) who also provided independent safety monitoring of the trial. Study commenced in September 2011. Recruitment completed in October 2014. Data collection is ongoing. Results will be reported in manuscripts submitted to peer-reviewed journals and in presentations at national and international meetings. TRIAL REGISTRATION NUMBERS: ACTRN12611000751976, NCT01486680; Pre-results.

Urinary intestinal fatty acid-binding protein concentration predicts extent of disease in necrotizing enterocolitis.

PURPOSE: Urinary intestinal fatty acid-binding protein (i-FABP), a marker of intestinal mucosal cell damage, has recently been proposed as a clinically useful measure in the early detection of necrotizing enterocolitis (NEC). However, there are no data on urinary i-FABP in more advanced (Bell stage II /III) NEC. The aim of this study was to test the use of urinary i-FABP in surgical NEC. METHODS: Urine was collected every 24 hours from infants with Bell stage II/III NEC admitted to a surgical Neonatal Intensive Care Unit. Clinical, laboratory, and surgical data were collected concurrently. Urinary i-FABP was quantified by enzyme-linked immunosorbent assay and expressed as picograms per nanomole creatinine (median [range]). Results are presented as median (range) and compared by Mann-Whitney test and by linear regression. RESULTS: There was a trend toward an increase in i-FABP:Cr in infants with NEC (controls, 1.0 [0.4-1.3], vs NEC, 2.1 [0.39-35.1], P = .055). Urinary i-FABP:Cr was significantly higher in infants with extensive disease (7.4 pg/mmol [2.1-35.0 pg/mmol]) than in those with focal disease (1.1 pg/mmol [0.3-1.7 pg/mmol]), P = .002. In addition, i-FABP:Cr was less than the previously suggested 2 pg/mmol cutoff in 6 of 16 infants with NEC, 5 of whom had focal disease. Urinary i-FABP:Cr decreased during both successful nonoperative management (P < .0001) and after surgery in the operated group. CONCLUSIONS: In this pilot study, urinary i-FABP was associated with extensive disease in infants with NEC requiring surgery. Further work, in a larger number of patients, is required to investigate the applicability of urinary i-FABP as a marker of intestinal damage and as an adjunct to current indications for surgical intervention in infants with NEC.