A randomized controlled trial comparing oral and intravenous iron supplementation after Roux-en-Y gastric bypass surgery.

BACKGROUND: Iron deficiency (ID) is one of the most common postoperative deficiencies that may develop after Roux-en-Y gastric bypass (RYGB). The optimal mode of treatment is uncertain. AIM: To compare the efficacy of oral ferrous fumarate (FF), oral ferrous gluconate (FG), and a single intravenous infusion of ferric carboxymaltose (FCM) in women with ID after RYGB. METHODS: Multicenter randomized controlled trial including 120 women with a serum ferritin <20 µg/l during follow-up after RYGB. They were randomized into three groups: 41 patients were treated with FF 200 mg three times a day (total daily dose: 195 mg elemental iron), 39 received FG 695 mg twice a day (total daily dose: 160 mg elemental iron) for three months, and 39 patients were treated with a single intravenous dose of FCM (1000 mg elemental iron). Serum ferritin levels were measured at six weeks, and three, six and twelve months after the start of supplementation. RESULTS: At three months, persistence of ID was observed in 29.4% and 42.4% of the patients treated with FF and FG, respectively, but in none of those treated with FCM (p < 0.001). Over the next nine months, recurrence of ID was observed in 56.5% of patients treated with FF, in 52.9% treated with FG, and in 27.8% of those treated with FCM. Adverse effects were most common during oral treatment. CONCLUSION: In women developing ID after RYGB, a single dose of intravenous FCM is more effective and better tolerated than the standard treatment with either FF or FG. CLINICAL TRIAL REGISTRY NUMBER AND WEBSITE: The study was registered at clinicaltrials.gov under number NCT02271997.

The True Story on Deficiencies After Sleeve Gastrectomy: Results of a Double-Blind RCT.

BACKGROUND: Since a few years, the laparoscopic sleeve gastrectomy (SG) has become the most performed bariatric operation worldwide. However, as with all bariatric procedures, SG also leads to vitamin and mineral deficiencies post-operatively and standard multivitamin supplements are probably not sufficient. OBJECTIVE: The present study evaluates the effectiveness of a specialized multivitamin supplement for SG patients (WLS Optimum 1.0, FitForMe, Rotterdam, the Netherlands), compared to a standard multivitamin supplement (sMVS). DESIGN: A double-blind randomized controlled trial was performed. For 12 months, patients in the intervention group received WLS Optimum, containing elevated doses of multiple vitamins and minerals. Patients in the control group were provided with sMVS, containing 100% of the recommended dietary allowance. RESULTS: In total, 139 patients were available for analysis (WLS Optimum, n = 69; sMVS, n = 70). Intention-to-treat analyses revealed more folic acid deficiencies and higher serum vitamin B1 levels in the WLS Optimum group. Per protocol analyses showed that in patients using WLS Optimum, serum folic acid and vitamin B1 levels were higher, serum PTH levels were lower, and only one patient (2.6%) was anemic compared to 11 patients (17.5%) using a sMVS (p < 0.05 for all). No differences were found in prevalence of deficiencies for iron, vitamin B12, vitamin D, and other vitamins and minerals. CONCLUSIONS: This optimized multivitamin supplement only affected serum levels of folic acid, PTH and vitamin B1, and anemia rates compared to a sMVS. There is a clear need to further optimize multivitamin supplementation for SG patients. Besides, non-compliance with multivitamin supplements remains an important issue that should be dealt with. CLINICAL TRIAL REGISTRY: The study protocol was registered at the clinical trials registry of the National Institutes of Health (ClinicalTrials.gov; identifier NCT01609387).

Correction to: Adequate Multivitamin Supplementation after Roux-En-Y Gastric Bypass Results in a Decrease of National Health Care Costs: a Cost-Effectiveness Analysis.

In the original article, there are some incorrect data in the "Results" section of the Abstract.

Adequate Multivitamin Supplementation after Roux-En-Y Gastric Bypass Results in a Decrease of National Health Care Costs: a Cost-Effectiveness Analysis.

INTRODUCTION: Patients with morbid obesity undergoing metabolic surgery are prone to develop vitamin and mineral deficiencies, which may worsen in time. In order to prevent these deficiencies after metabolic surgery, all patients are advised to take daily multivitamin supplementation. The aim of the study was to assess the cost-effectiveness of specially developed multivitamins (WLS Forte®) for metabolic surgery and over-the-counter (standard) multivitamin supplementation (sMVS). METHODS: This cost-effectiveness analysis was preformed alongside an RCT for the Netherlands. Between June 2011 and March 2012, a total of 148 patients were randomized to one tablet daily of either WLS Forte® or sMVS. The patients were followed for 12 months. Data on costs within the health sector and outside the health sector were collected. The primary outcome is financial and logistic advantages, in terms of less patient visits to the outpatient department and the relevant costs to the employer due to absenteeism. RESULTS: In total, 10 (14%) patients in the WLS Forte® group versus 23 (30%) patients in the sMVS group developed a deficiency. The costs for the WLS forte® supplement were €38 versus €23 for sMVS. Additional return visits and associated costs for medical staff were the largest costs, up to 43% in the sMVS group. Total costs for supplementation with sMVS were €243 versus €134 for WLS Forte®. CONCLUSION: Preventing deficiencies with WLS Forte® seem initially more expensive than sMVS. However, treatment with WLS Forte® resulted in less vitamin and mineral deficiencies, which eventually resulted in less overall costs.

Altered neural responsivity to food cues in relation to food preferences, but not appetite-related hormone concentrations after RYGB-surgery.

BACKGROUND: After Roux-en-Y gastric bypass (RYGB) surgery, patients report a shift in food preferences away from high-energy foods. OBJECTIVE: We aimed to elucidate the potential mechanisms underlying this shift in food preferences by assessing changes in neural responses to food pictures and odors before and after RYGB. Additionally, we investigated whether altered neural responsivity was associated with changes in plasma endocannabinoid and ghrelin concentrations. DESIGN: 19 RYGB patients (4 men; age 41 ± 10 years; BMI 41 ± 1 kg/m2 before; BMI 36 ± 1 kg/m2 after) participated in this study. Before and two months after RYGB surgery, they rated their food preferences using the Macronutrient and Taste Preference Ranking Task and BOLD fMRI responses towards pictures and odors of high-, and low-energy foods and non-food items were measured. Blood samples were taken to determine plasma endocannabinoid and ghrelin concentrations pre- and post-surgery. RESULTS: Patients demonstrated a shift in food preferences away from high-fat/sweet and towards low-energy/savory food products, which correlated with decreased superior parietal lobule responsivity to high-energy food odor and a reduced difference in precuneus responsivity to high-energy versus low-energy food pictures. In the anteroventral prefrontal cortex (superior frontal gyrus) the difference in deactivation towards high-energy versus non-food odors reduced. The precuneus was less deactivated in response to all cues. Plasma concentrations of anandamide were higher after surgery, while plasma concentrations of other endocannabinoids and ghrelin did not change. Alterations in appetite-related hormone concentrations did not correlate with changes in neural responsivity. CONCLUSIONS: RYGB leads to changed responsivity of the frontoparietal control network that orchestrates top-down control to high-energy food compared to low-energy food and non-food cues, rather than in reward related brain regions, in a satiated state. Together with correlations with the shift in food preference from high- to low-energy foods this indicates a possible role in new food preference formation.

Efficacy of oral compared with intramuscular vitamin B-12 supplementation after Roux-en-Y gastric bypass: a randomized controlled trial.

Background: After Roux-en-Y gastric bypass (RYGB), patients often develop a vitamin B-12 deficiency. Objective: Our objective was to investigate whether oral supplementation increases and normalizes low vitamin B-12 concentrations (vitamin B-12 > 200 pmol/L) in RYGB patients as compared to intramuscular injections. Design: A randomized controlled trial in RYGB patients with subnormal serum B-12 concentrations was performed. One group (IM B-12) received bimonthly intramuscular hydroxocobalamin injections (2000 µg as loading dose and 1000 µg at follow-up) for 6 mo. The second group (oral B-12) received daily doses of oral methylcobalamin (1000 µg). Serum vitamin B-12 was determined at baseline (T0) and at 2 (T1), 4 (T2), and 6 mo (T3) after start of treatment. Concentrations of the secondary markers methylmalonic acid (MMA) and homocysteine (Hcy) were measured at T0 and T3. Results: Fifty patients were included and randomized, 27 in IM B-12 and 23 in oral B-12. The median vitamin B-12 concentration at T0 was 175 pmol/L (range: 114-196 pmol/L) for IM B-12 and 167 pmol/L (range: 129-199 pmol/L) for oral B-12. Vitamin B-12 normalized in all individuals, and there was no significant difference in vitamin B-12 between the two groups. MMA and Hcy concentrations decreased significantly after 6 mo within each group (P < 0.001 and P < 0.001 for MMA and P = 0.03 and P = 0.045 for Hcy, respectively). There was no significant difference between the groups at 6 mo for both MMA and Hcy (P = 0.53 and P = 0.79). Conclusion: The efficacy of oral vitamin B-12 supplementation was similar to that of hydroxocobalamin injections in the present study. Oral supplementation can be used as an alternative to hydroxocobalamin injections to treat RYGB patients with low values of serum vitamin B-12. This trial was registered at clinicaltrials.gov as NCT02270749.

Do specialized bariatric multivitamins lower deficiencies after RYGB?

BACKGROUND: One of the side effects of bariatric surgery is the risk of vitamin and mineral deficiencies. Vitamin B12, vitamin D, folate, and iron deficiencies are especially common among Roux-en-Y gastric bypass patients. OBJECTIVE: To examine the effectiveness of a specialized multivitamin supplement for Roux-en-Y gastric bypass patients on deficiencies the first 3 years postoperatively, retrospectively in a large, prospectively collected cohort. SETTING: Large specialized bariatric hospital. RESULTS: One thousand one hundred sixty patients were included, 883 users and 258 who were nonusers of the specialized multivitamin. Patient characteristics and total weight were comparable. Higher serum concentrations of ferritin (124.7 ± 96.2 µg/L versus 106.0 ± 83.0 µg/L, P = .016), vitamin B12 (347.3 ± 145.1 pmol/L versus 276.8 ± 131.4 pmol/L, P<.001), folic acid (34.9 ± 9.6 nmol/L versus 25.4 ± 10.7 nmol/L, P<.001), and vitamin D (98.4 ± 28.7 nmol/L versus 90.0 ± 34.5 nmol/L, P = .002) were observed in users compared with nonusers after 1 year. Less new deficiencies were found for ferritin (1% versus 4%, P = .029), vitamin B12 (9% versus 23%, P<.001), and vitamin D (0% versus 4%, P<.001) in users compared with nonusers. Two and 3 years after the surgery these findings remained almost identical. CONCLUSIONS: The use of specialized multivitamin supplements resulted in less deficiencies of vitamin B12, vitamin D, folic acid, and ferritin. The study showed that Roux-en-Y gastric bypass patients benefited from the specialized multivitamin supplements and it should be advised to this patient group.

Changes in Iron Absorption After Roux-en-Y Gastric Bypass.

INTRODUCTION: Iron deficiency is one of the most common deficiencies that may occur after Roux-en-Y gastric bypass (RYGB). Little is known about the optimal treatment of post-RYGB iron deficiency. AIM: The aim of this study is to evaluate the changes in iron absorption characteristics after RYGB for two oral iron formulations, one presented in tablet form and one as in the form of a solution. METHOD: Iron absorption in 24 obese women was studied before and 1 month after RYGB. Twelve patients were tested with a single dose of 600 mg ferrous fumarate in tablet form (195 mg of elementary iron, group 1), and 12 patients received a single dose of 1390 mg ferrous gluconate as a solution (160 mg of elementary iron, group 2). Serum iron levels were measured before (T0) and every hour after ingestion of the supplement (T1-T9). RESULTS: Before surgery, iron absorption was similar for the two supplements (P = 0.71). However, RYGB was associated with a decrease in fumarate iron absorption (P < 0.001) but did not affect gluconate iron absorption (P = 0.13). Postoperative absorption of fumarate iron was significantly lower than gluconate iron at T1 (P < 0.05), but the overall difference over 9 h did not reach statistical significance (P = 0.53). CONCLUSION: RYGB adversely affects the absorption of ferrous fumarate tablets but not that of solubilized ferrous gluconate. A solubilized supplement is therefore preferred as the supplement of first choice after RYGB.

Treatment of Vitamin and Mineral Deficiencies After Biliopancreatic Diversion With or Without Duodenal Switch: a Major Challenge.

BACKGROUND: Vitamin and mineral deficiencies are a major concern after biliopancreatic diversion (BPD) and BPD with duodenal switch (BPD/DS). Evidence-based guidelines how to prevent or how to treat deficiencies in these patients are currently lacking. The aim of the current study is to give an overview of postsurgical deficiencies and how to prevent and treat these deficiencies. METHODS: Retrospective evaluation of a 1-year structured monitoring and treatment schedule for various deficiencies in 34 patients after BPD or BPD/DS. RESULTS: Patients were introduced into the program 12-90 months after surgery. Vitamin B1, B6, B9, and B12 deficiencies could be prevented by mean daily doses of 2.75 mg, 980 µg, 600 µg, and 350 µg, respectively. However, many patients continued to develop deficiencies of vitamin A, D, iron, calcium, and zinc despite major dose adjustments. Current observations suggest that at least total daily doses of 200 mg Fe in premenopausal women and 100 mg in men, 100 mg of Zinc, 3000 mg of calcium, and weekly doses of at least 50,000 IU solubilized vitamin A and vitamin D are needed to prevent the occurrence of major deficiencies. CONCLUSION: Exceptionally high supplementation doses are needed to prevent and treat vitamin and mineral deficiencies in patients after BPD or BPD/DS. Further refinement and simplification of treatment schedules is needed. Focus on improvement of compliance to treatment is recommended.

Patients' Preoperative Estimate of Target Weight and Actual Outcome after Bariatric Surgery.

BACKGROUND: Evidence about the impact of psychological factors on weight loss after bariatric surgery is scarce. This study explores whether patients' preoperative estimate of target weight influences actual weight loss for different types of bariatric procedures. METHODS: Patients eligible for bariatric surgery were instructed twice on how to calculate their expected target weight. They were divided into three groups based on their percentage excess weight loss (%EWL) and percentage total body weight loss (%TBWL). Weight loss 12 and 24 months after surgery was analyzed for each group and per type of surgery. RESULTS: Six hundred fifty-six patients participated in this study. Types of surgery performed were the Roux-en-Y gastric bypass (RYGB, 75%), sleeve gastrectomy (SG, 8.1%), REDO-RYGB (12.5%), and laparoscopic adjustable gastric banding (LAGB, 4.4%). Data of 622 and 410 patients were available for analysis at 12 and 24 months, respectively. Surprisingly, 415 patients (63.3%) overestimated their expected weight loss as opposed to our calculation, based on our own historic data. One hundred thirty-four patients (20.4%) estimated their weight loss correctly and 107 patients (16.3%) underestimated their weight loss. There was a significant higher %EWL 12 months after RYGB surgery for patients who overestimated their weight loss compared to those who estimated their weight loss correctly (p = 0.001). After 24 months and for other types of procedures, no statistically significant differences were found between the three groups. CONCLUSION: Despite instructions on how to calculate target weight, the majority of patients overestimated their weight loss. Actual %EWL 12 months after RYGB surgery might be influenced by setting a low target weight.

Medial lower leg perforators: An anatomical study of their distribution and characteristics.

PURPOSE: The integument of the medial lower leg is underestimated as a donor site for local and distant reconstructions. Comprehensive knowledge of its perforator anatomy is lacking. This study aims to determine perforator location and characteristics and to compare these regarding the proximal, middle and distal third of the medial lower leg. MATERIALS AND METHODS: The medial lower leg region (MLLR) of 16 cadavers was delineated and investigated after injecting the popliteal artery with acrylic paint. Following dissection, all perforators larger than 0.3 mm were localized and mapped. Their course, source vessel, length and diameter were subsequently documented. RESULTS: Overall, 122 perforators were found, 102 (83.6%) originating from the posterior tibial artery, 16 (13.1%) from the medial sural artery and 4 (3.3%) from the anterior tibial artery. A mean of 7.6 ± 2.4 perforators (range 4-13) per MLLR was found. Most perforators (42.6%) were localized in the distal third of the MLLR, followed by the middle (36.9%) and proximal third (20.5%). The largest and longest perforators were found in the proximal third of the MLLR (diameter 1.4 mm, length 9.1 cm), followed by the middle and distal third respectively. Of all musculocutaneous perforators, the majority (78.6%) was located in the middle third of the MLLR. Of all septocutaneous perforators, most (55.3%) were found in the distal third of the MLLR. A small number of unexpected anatomical variants were found. CONCLUSION: In each third of the MLLR different perforator characteristics were found. Knowledge of these characteristics can be used to direct the reconstructive plan. © 2016 Wiley Periodicals, Inc. Microsurgery 37:319-326, 2017.

Loose and frequent stools and PTH levels are positively correlated post-gastric bypass surgery due to less efficient intestinal calcium absorption.

BACKGROUND: After Roux-en-Y gastric bypass, calcium and vitamin D deficiencies are frequently reported. In the presence of adequate vitamin D levels, calcium deficiency is caused by a lower efficacy of the intestinal calcium transport. OBJECTIVE: To investigate whether the use of a simple clinical score quantifying bowel habits (fecal score [FS]) correlates with the degree of secondary hyperparathyroidism that arises to compensate for calcium deficiency postsurgery. SETTING: Large peripheral hospital. METHODS: Seventy-five patients supplemented with calcium and vitamin D were prospectively studied before and 6 and 12 months after Roux-en-Y gastric bypass. FS, calcium (mmol/L), phosphate (mmol/L), magnesium (mmol/L), vitamin D (nmol/L), and parathyroid hormone (PTH; pmol/L) were measured in each patient. RESULTS: Mean body mass index was 44.7±5.4 kg/m2 preoperatively and decreased to 34.3±5.0 kg/m2 at 6 months and 30.8±4.8 kg/m2 at 12 months, corresponding to a total weight loss of 23.2±5.9% and 30.9±8.3% respectively. There were no significant changes in serum calcium levels. Mean PTH levels rose from 3.5 pmol/L at baseline to 4.1 pmol/L at 6 months (P = .01) and to 4.9 pmol/L at 12 months (P<.001). Nine patients (12%) had increased PTH levels at 6 months, and 14 patients (19%) had increased PTH levels at 12 months. A significant positive correlation between FS and PTH at 12 months was found, which persisted after adjusting for vitamin D levels. CONCLUSION: FS is positively correlated with secondary hyperparathyroidism using vitamin D-adjusted PTH levels as a biochemical marker. The present study in humans confirms the relation reported in animal studies. These results emphasize that managing stool habits are important after bariatric surgery.

An optimized multivitamin supplement lowers the number of vitamin and mineral deficiencies three years after Roux-en-Y gastric bypass: a cohort study.

BACKGROUND: Vitamin and mineral deficiencies are common after Roux-en-Y gastric bypass (RYGB) surgery. In particular, inadequate serum concentrations of ferritin and vitamin B12 have been found in 11% and 23% (respectively) of patients using a standard multivitamin supplement (sMVS) 1 year after RYGB. OBJECTIVE: To evaluate the effectiveness and safety of Weight Loss Surgery (WLS) Forte® (a pharmaceutical-grade, optimized multivitamin supplement) compared with an sMVS and a control group (nonuser) 3 years after RYGB. SETTING: General hospital specialized in bariatric surgery. METHODS: A follow-up cohort study of a triple-blind randomized, controlled clinical trial. RESULTS: At baseline 148 patients were enrolled (74 [50%] in the sMVS group and 74 [50%] in the WLS Forte group). After a mean follow-up of 36 months, 11 (7%) patients were lost to follow-up, of whom 2 were secondary to death. At the end of the study, 11 (17%) patients in the WLS Forte and 17 (24%) in the sMVS group stopped using a supplement. In addition, 64 (47%) patients were using WLS Forte and 45 (33%) patients a sMVS. Patient characteristics and follow-up length were comparable between the groups. Significantly more patients were diagnosed with anemia (16% versus 3% [P = .021]), a ferritin deficiency (14% versus 3% [P = .043]), and a zinc deficiency (8% versus 0% [P = .033]) in the sMVS group compared with WLS Forte. Five patients developed a vitamin B12 deficiency while using WLS Forte, versus 15 of sMVS users (P = .001). No adverse events occurred that were related to supplement use. CONCLUSION: At 3 years postoperative of RYGB, an optimized multivitamin supplement (WLS Forte) was more effective in reducing anemia and ferritin, vitamin B12, and zinc deficiencies compared with a standard supplement and control.

Subclinical hypothyroidism and its relation to obesity in patients before and after Roux-en-Y gastric bypass.

BACKGROUND: Subclinical hypothyroidism (SH), defined as a raised serum thyroid-stimulating hormone (TSH) with a normal free thyroxine (FT4), is occasionally observed in morbidly obese patients. OBJECTIVES: It is currently not known whether thyroid hormone treatment is indicated. The aim of the present study was to assess the changes in thyroid hormone levels in thyroxine-naïve patients with SH in response to weight loss induced by Roux-en-Y gastric bypass (RYGB). SETTING: General hospital specialized in bariatric surgery. METHODS: Serum levels of TSH and FT4 were measured at baseline in 503 patients presenting for RYGB. In patients diagnosed with SH, these measurements were repeated 12 months postoperatively. RESULTS: SH de novo was present in 71 out of 503 patients (14.1%). One-year follow-up was available in 61 out of 71 patients (86%). TSH level >10 mU/L was observed in 3 patients (.5%). RYGB induced a decrease in BMI from 47±8 kg/m(2) to 33±6 kg/m(2) at 12-month follow-up (P<.001), and this was associated with a decrease in TSH from 5.8±2.0 to 2.8±1.3 mU/L (P<.001) and a decrease in FT4 from 15.2±2.1 to 13.9±2.3 pmol/L (P<.001), respectively. SH completely resolved in 53 (87%) of the de novo cases. CONCLUSION: The prevalence of SH de novo is high in morbidly obese patients. After RYGB it resolves in about 90% of patients. This high degree of spontaneous recovery suggests that follow-up alone is sufficient in the majority of patients.

Lateral lower leg perforator flaps: an anatomical study to localize and classify lateral lower leg perforators.

Despite increasing use of lateral lower leg perforator flaps, comprehensive anatomical data are still lacking. The aim of this article was to comprehensively document the pattern of usable lateral lower leg perforators. Systematic mapping of 16 cadaver leg perforators in a well-defined area was performed to elucidate location, course, length, diameter, and origin. Overall, 197 perforators were found in 16 lateral lower legs. The mean number of perforators per leg with a diameter ≥ 0.3 mm was 13.4 ± 3.6. Most perforators were found in the distal third (39.0%), followed by the middle third (32.0%), and proximal third (29.0%). A musculocutaneous course was found in 26.9% of the perforators, whereas 73.1% revealed a septocutaneous course. Most septocutaneous perforators (50.0%) were found in the distal third and most musculocutaneous perforators (58.5%) in the proximal third (P < 0.001). The majority of perforators originated from the anterior tibial artery (53.0%), followed by the peroneal artery (41.6%), and the popliteal artery (5.1%). Popliteal artery perforators (1.64 mm) were significantly larger than anterior tibial artery (0.91 mm) and peroneal artery perforators (1.02 mm; P < 0.001). These results may facilitate tissue transfer around the lateral lower leg.