The Metabolic Health Index Identifies Patients That Will Benefit From Metabolic Surgery.

INTRODUCTION: Metabolic syndrome is a modern world's major health hazard related to comorbidities like type 2 diabetes and cardiovascular disease. Bariatric surgery is well known to lower this health risk in patients with obesity. There is a need for an objective measure to assess the intended reduction in health hazard and indirectly the eligibility for bariatric surgery. The Metabolic Health Index (MHI) quantitatively summarizes the cumulative impact of the metabolic syndrome on health status on a scale from 1 to 6. This study describes the use of the MHI as a supportive tool in the decision for and outcome assessment of bariatric surgery. METHODS: The general usability of the MHI was tested by extending its application to patient data of five other bariatric centers in the Netherlands. Retrospective laboratory and national bariatric quality registry data of 11,501 patients were collected. RESULTS: The quantification of (improvement in) metabolic health burden as measured by the MHI was independent of the dataset that was used to derive the MHI model. Patients with MHI > 2.8 prior to surgery improved significantly more in MHI 12 mo after surgery compared to patients with MHI ≤ 2.8 (1.1 compared to 0.4 MHI points, respectively; P < 0.001). CONCLUSIONS: The MHI is robust between centers and is suitable for general use in clinical decision-making. As changes in MHI over time reflect metabolic health alterations, it is suitable as an outcome measure of surgery. An MHI cut-off value of 2.8 helps to predict the likelihood of significant improvement after surgery, independent of body mass index and known metabolic comorbidities.

Three- and five-year follow-up results of a randomized controlled trial on the effects of cognitive behavioral therapy before bariatric surgery.

OBJECTIVE: Up to 37% of bariatric surgery patients suffer from insufficient weight loss or weight regain and mental health symptoms in the longer term. Cognitive behavioral therapy (CBT) may be an effective adjunct intervention to optimize patients' psychological functioning and weight loss results. To examine the value of adding preoperative CBT to bariatric surgery, three- and five-year follow-up data are presented. METHOD: In this multi-center randomized controlled trial (RCT; N = 130), a CBT group was compared to a treatment-as-usual (TAU) control group. Measurements were conducted at five time points: pretreatment (T0) and posttreatment/presurgery (T1) and at one- (T2; N = 120), three- (T3; N = 117), and five-year postsurgery (T4; N = 115). The intervention group received a 10-weeks, individual, preoperative CBT focused on self-monitoring, identifying triggers for disordered eating and goal setting for eating behavior and physical exercise, as well as postoperative lifestyle. Outcome measures included weight change, eating behavior, eating disorders, depression, quality of life (QoL), and overall psychological health. RESULTS: Preoperative CBT was not associated with better three- and five-year results than TAU regarding weight, dysfunctional eating behaviors, eating disorders, depression, overall psychological health, and QoL. DISCUSSION: Contrary to our hypothesis, three- and five-year postsurgery differences between groups regarding weight change and mental health were not significant.. Further exploration suggested that in both groups weight problems and depressive symptoms worsened at three and five-year follow-up. Future research should focus on long-term postoperative monitoring of weight and mood and on associated postoperative interventions and their specific timing. PUBLIC SIGNIFICANCE: After bariatric surgery, in the longer term weight problems re-occur in 30% of patients, which is probably partly related to psychopathology. We investigated whether cognitive behavior therapy (CBT) prior to bariatric surgery improved weight maintenance and mental health after surgery. Our study provided definite proof that preoperative CBT is not effective. Long-term postoperative monitoring and prompt psychological intervention after first signs of deterioration, are important to prevent further problems.

Low-pressure pneumoperitoneum with deep neuromuscular blockade in metabolic surgery to reduce postoperative pain: a randomized pilot trial.

BACKGROUND: For metabolic laparoscopic surgery, higher pressures up to 20 mmHg are often used to create a surgical field of sufficient quality. This randomized pilot study aimed to determine the feasibility, safety and tolerability of low intraabdominal pressure (IAP) and deep neuromuscular blockade (NMB) to reduce postoperative pain. METHODS: In a teaching hospital in the Netherlands, 62 patients eligible for a laparoscopic Roux-en-Y gastric bypass (LRYGB) were randomized into one of four groups in a 2 × 2 factorial design: deep/moderate NMB and standard (20 mmHg)/low IAP (12 mmHg). Patient and surgical team were blinded. Primary outcome measure was the surgical field quality, scored on the Leiden-Surgical Rating Scale (L-SRS). Secondary outcome measures were (serious) adverse events, duration of surgery and postoperative pain. RESULTS: 62 patients were included. L-SRS was good or perfect in all patients that were operated under standard IAP with deep or moderate NMB. In 40% of patients with low IAP and deep NMB, an increase in IAP was needed to improve surgical overview. In patients with low IAP and moderate NMB, IAP was increased to improve surgical overview in 40%, and in 75% of these cases a deep NMB was requested to further improve the surgical overview. Median duration of surgery was 38 min (IQR34-40 min) in the group with standard IAP and moderate NMB and 52 min (IQR46-55 min) in the group with low IAP and deep NMB. CONCLUSIONS: The combination of moderate NMB and low IAP can create insufficient surgical overview. Larger trials are needed to corroborate the findings of this study. TRIAL REGISTRATION: Dutch Trial Register: Trial NL7050, registered 28 May 2018. https://www.trialregister.nl/trial/7050 .

Reducing complication rates and hospital readmissions while revising the enhanced recovery after bariatric surgery (ERABS) protocol.

BACKGROUND: To optimize the postoperative phase following bariatric surgery, the enhanced recovery after bariatric surgery pathway (ERABS) has been developed. The aim of ERABS is to create a care path that is as safe, efficient and patient-friendly as possible. Continuous evaluation and optimization of ERABS are important to ensure a safe treatment path and may result in better outcomes. The objective of this study was to compare the clinical outcomes of patients undergoing bariatric surgery over 2014-2017, during which the ERABS protocol was continuously evaluated and optimized. METHODS: This is a retrospective cohort study. Data were collected from patients undergoing a primary Roux-en-Y gastric bypass or sleeve gastrectomy between January 2014 and December 2017. Outcomes were early complications, unplanned hospital revisits, readmissions, duration of surgery and length of hospital stay. RESULTS: 2889 patients underwent a primary bariatric procedure in a single center. There was a significant decrease in minor complications over the years from 7.0 to 1.9% (p < 0.001). Hospital revisit rates decreased after 2015 (p < 0.001). Readmission rates decreased over time (p < 0.001). The mean duration of surgery decreased from 52 (in 2014) to 41 (in 2017) minutes (p < 0.001). Median length of hospital stay decreased from 1.8 to 1.5 days in 2015 (p = 0.002) and remained stable since. CONCLUSION: An improvement of the ERABS protocol was associated with a decrease in minor complication rates, number of unplanned hospital revisits and readmission rates after primary bariatric procedures.

The first modified Delphi consensus statement on sleeve gastrectomy.

INTRODUCTION: Sleeve gastrectomy (SG) is the commonest bariatric procedure worldwide. Yet there is significant variation in practice concerning its various aspects. This paper report results from the first modified Delphi consensus-building exercise on SG. METHODS: We established a committee of 54 globally recognized opinion makers in this field. The committee agreed to vote on several statements concerning SG. An agreement or disagreement amongst ≥ 70.0% experts was construed as a consensus. RESULTS: The committee achieved a consensus of agreement (n = 71) or disagreement (n = 7) for 78 out of 97 proposed statements after two rounds of voting. The committee agreed with 96.3% consensus that the characterization of SG as a purely restrictive procedure was inaccurate and there was 88.7% consensus that SG was not a suitable standalone, primary, surgical weight loss option for patients with Barrett's esophagus (BE) without dysplasia. There was an overwhelming consensus of 92.5% that the sleeve should be fashioned over an orogastric tube of 36-40 Fr and a 90.7% consensus that surgeons should stay at least 1 cm away from the angle of His. Remarkably, the committee agreed with 81.1% consensus that SG patients should undergo a screening endoscopy every 5 years after surgery to screen for BE. CONCLUSION: A multinational team of experts achieved consensus on several aspects of SG. The findings of this exercise should help improve the outcomes of SG, the commonest bariatric procedure worldwide, and guide future research on this topic.

The effect of sex and menopause on carotid intima-media thickness and pulse wave velocity in morbid obesity.

BACKGROUND: Women are relatively protected from cardiovascular disease compared with men. Since morbid obesity is an independent risk factor for cardiovascular disease, the current study investigated whether the association between sex and cardiovascular risk factors and outcomes can be demonstrated in subjects suffering from morbid obesity. MATERIALS AND METHODS: Two hundred subjects enrolled in a study on cardiovascular risk factors in morbid obesity underwent extensive laboratory screening, carotid intima-media thickness (cIMT) and pulse wave velocity (PWV) measurements. Gender differences were analysed using univariate and multivariable linear regression models. In addition, the effect of menopause on cIMT and PWV was analysed. Results of these models were reported as B coefficients with 95% confidence intervals. RESULTS: The group consisted of 52 men and 148 women, with a mean age of 41 (±11.8) years and a mean body mass index (BMI) of 42.7 (±5.2) kg/m2 . Both, cIMT and PWV were significantly higher in men than in women, although the difference in cIMT disappeared after adjustment for covariables such as waist circumference, age, high-density lipoprotein cholesterol and mean arterial pressure. PWV was associated with sex after adjustments for covariables in morbidly obese patients. Postmenopausal women had significantly increased cIMT and PWV when compared with premenopausal women. CONCLUSION: Sex differences in PWV persist in subjects suffering from morbid obesity. However, no difference was found in cIMT between morbidly obese men and women after adjustment for classic cardiovascular risk factors. Premenopausal morbidly obese women are protected for cardiovascular disease when compared with postmenopausal morbidly obese women.

The use of negative-pressure wound therapy in pilonidal sinus disease: a randomized controlled trial comparing negative-pressure wound therapy versus standard open wound care after surgical excision.

BACKGROUND: Pilonidal sinus disease is associated with significant morbidity after surgical treatment with regard to wound healing. Recent case studies suggested that negative-pressure wound therapy as primary treatment following surgical excision may shorten the duration of wound healing. OBJECTIVE: The purpose of this randomized controlled trial was to evaluate the role of vacuum therapy in pilonidal sinus disease: negative-pressure wound therapy versus standard open wound care after surgical excision. METHODS: Patients were randomly assigned to either negative-pressure wound therapy for 2 weeks or standard open wound healing. The primary end point of the study was the time to complete wound healing. Secondary end points were visual analog scale score, wound size ratio at day 14 (ie, wound healing rate), time to resume daily activities, and recurrence within 6 months after wound closure. RESULTS: Forty-nine patients were included in the study: 24 patients were treated with vacuum therapy, and 25 patients underwent standard open wound care. Complete wound healing was achieved at a median of 84 days in the vacuum therapy group versus 93 days in control patients (p = 0.44). The wound size ratio was significantly lower in the vacuum therapy group (0.30 versus 0.57, p = 0.02), ie, higher wound healing rate in the first 2 weeks. There was no difference in visual analog scale scores and disease recurrence between both groups. The time to resume full daily activities after surgery was 27 days in the patients undergoing vacuum therapy and 29 days in the control patients (p = 0.92). LIMITATIONS: This study is limited by the small number of patients, the lack of blinding to patients and doctors, and the absence of patient quality-of-life evaluation. CONCLUSION: It is feasible to apply vacuum therapy in the treatment of pilonidal sinus disease, and it has a positive effect on wound size reduction in the first 2 weeks. However, there is no difference in time to complete wound healing and time to resume daily life activities.

Long-term effect of sleeve gastrectomy vs Roux-en-Y gastric bypass in people living with severe obesity: a phase III multicentre randomised controlled trial (SleeveBypass).

Background: Sleeve gastrectomy is the most performed metabolic surgical procedure worldwide. However, conflicting results offer no clear evidence about its long-term clinical comparability to Roux-en-Y gastric bypass. This study aims to determine their equivalent long-term weight loss effects. Methods: This randomised open-label controlled trial was conducted from 2012 until 2017 in two Dutch bariatric hospitals with a 5-year follow-up (last follow-up July 29th, 2022). Out of 4045 patients, 628 were eligible for metabolic surgery and were randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass (intention-to-treat). The primary endpoint was weight loss, expressed by percentage excess body mass index (BMI) loss. The predefined clinically relevant equivalence margin was -13% to 13%. Secondary endpoints included percentage total kilograms weight loss, obesity-related comorbidities, quality of life, morbidity, and mortality. This trial is registered with Dutch Trial Register NTR4741: https://onderzoekmetmensen.nl/nl/trial/25900. Findings: 628 patients were randomised between sleeve gastrectomy (n = 312) and Roux-en-Y gastric bypass (n = 316) (mean age 43 [standard deviation (SD), 11] years; mean BMI 43.5 [SD, 4.7]; 81.8% women). Excess BMI loss at 5 years was 58.8% [95% CI, 55%-63%] after sleeve gastrectomy and 67.1% [95% CI, 63%-71%] after Roux-en-Y gastric bypass (difference 8.3% [95% CI, -12.5% to -4.0%]). This was within the predefined margin (P < 0.001). Total weight loss at 5 years was 22.5% [95% CI, 20.7%-24.3%] after sleeve gastrectomy and 26.0% [95% CI, 24.3%-27.8%] after Roux-en-Y gastric bypass (difference 3.5% [95% CI, -5.2% to -1.7%]). In both groups, obesity-related comorbidities significantly improved after 5 years. Dyslipidaemia improved more frequently after Roux-en-Y gastric bypass (83%, 54/65) compared to sleeve gastrectomy (62%, 44/71) (P = 0.006). De novo gastro-oesophageal reflux disease occurred more frequently after sleeve gastrectomy (16%, 46/288) vs Roux-en-Y gastric bypass (4%, 10/280) (P < 0.001). Minor complications were more frequent after Roux-en-Y gastric bypass (5%, 15/316) compared to sleeve gastrectomy (2%, 5/312). No statistically significant differences in major complications and health-related quality of life were encountered. Interpretation: In people living with obesity grades 2 and 3, sleeve gastrectomy and Roux-en-Y gastric bypass had clinically comparable excess BMI loss according to the predefined definition for equivalence. However, Roux-en-Y gastric bypass showed significantly higher total weight loss and significant advantages in secondary outcomes, including dyslipidaemia and GERD, yet at a higher rate of minor complications. Major complications, other comorbidities, and overall HRQoL did not significantly differ between the groups. Funding: Not applicable.

Early conversion to below-elbow cast for non-reduced diaphyseal both-bone forearm fractures in children is safe: preliminary results of a multicentre randomised controlled trial.

INTRODUCTION: This multicentre randomised controlled trial was designed to explore whether 6 weeks above-elbow cast (AEC) or 3 weeks AEC followed by 3 weeks below-elbow cast (BEC) cause similar limitation of pronation and supination in non-reduced diaphyseal both-bone forearm fractures in children. MATERIALS AND METHODS: Children were randomly allocated to 6 weeks AEC or to 3 weeks AEC followed by 3 weeks BEC. The primary outcome was limitation of pronation and supination after 6 months. The secondary outcomes were re-displacement of the fracture, complication rate, limitation of flexion and extension of wrist and elbow, cast comfort, cosmetics, complaints in daily life and assessment of radiographs. RESULTS: A group of 23 children was treated with 6 weeks AEC and 24 children with 3 weeks AEC and 3 weeks BEC. The follow-up rate was 98 % with a mean follow-up of 7.0 months. The mean limitation of pronation and supination was 23.3 ± 22.0 for children treated with AEC and 18.0 ± 16.9 for children treated with AEC and BEC. The other study outcomes were similar in both groups. CONCLUSIONS: Early conversion to BEC is safe in the treatment of non-reduced diaphyseal both-bone forearm fractures in children. LEVEL OF EVIDENCE: Multicentre randomised controlled trial, Level II.

Conversion to below-elbow cast after 3 weeks is safe for diaphyseal both-bone forearm fractures in children.

BACKGROUND: It is unclear whether it is safe to convert above-elbow cast (AEC) to below-elbow cast (BEC) in a child who has sustained a displaced diaphyseal both-bone forearm fracture that is stable after reduction. In this multicenter study, we wanted to answer the question: does early conversion to BEC cause similar forearm rotation to that after treatment with AEC alone? CHILDREN AND METHODS: Children were randomly allocated to 6 weeks of AEC, or 3 weeks of AEC followed by 3 weeks of BEC. The primary outcome was limitation of pronation/supination after 6 months. The secondary outcomes were re-displacement of the fracture, limitation of flexion/extension of the wrist and elbow, complication rate, cast comfort, complaints in daily life, and cosmetics of the fractured arm. RESULTS: 62 children were treated with 6 weeks of AEC, and 65 children were treated with 3 weeks of AEC plus 3 weeks of BEC. The follow-up rate was 60/62 and 64/65, respectively with a mean time of 6.9 (4.7-13) months. The limitation of pronation/supination was similar in both groups (18 degrees for the AEC group and 11 degrees for the AEC/BEC group). The secondary outcomes were similar in both groups, with the exception of cast comfort, which was in favor of the AEC/BEC group. INTERPRETATION: Early conversion to BEC cast is safe and results in greater cast comfort.

Normalization of Cardiac Function After Bariatric Surgery Is Related to Autonomic Function and Vitamin D.

PURPOSE: Subclinical cardiac dysfunction is common in patients with obesity. Bariatric surgery is associated with normalization of subclinical cardiac function in 50% of the patients with obesity. The aim of this study was to identify predictors for a lack of improvement of subclinical cardiac dysfunction 1-year post-bariatric surgery. METHODS: Patients who were referred for bariatric surgery were enrolled in a longitudinal study. Inclusion criteria were age 35-65 years and BMI ≥ 35 kg/m2. Patients with a suspicion of or known cardiovascular disease were excluded. Conventional and advanced echocardiography, Holter monitoring, and blood tests were performed pre- and 1-year post-bariatric surgery. Subclinical cardiac dysfunction was defined as either a reduced left ventricular ejection fraction, decreased global longitudinal strain (GLS), diastolic dysfunction, arrhythmia, or an increased BNP or hs Troponin I. RESULTS: A total of 99 patients were included of whom 59 patients had cardiac dysfunction at baseline. Seventy-two patients completed the 1-year follow-up after bariatric surgery. There was a significant reduction in weight and cardiovascular risk factors. Parameters of cardiac function, such as GLS, improved. However, in 20 patients cardiac dysfunction persisted. Multivariate analysis identified a decreased heart rate variability (which is a measure of autonomic function), and a decreased vitamin D pre-surgery as predictors for subclinical cardiac dysfunction after bariatric surgery. CONCLUSION: Although there was an overall improvement of cardiac function 1-year post-bariatric surgery, autonomic dysfunction and a decreased vitamin D pre-bariatric surgery were predictors for a lack of improvement of subclinical cardiac dysfunction.

Cardiovascular Biomarker Profiles in Obesity and Relation to Normalization of Subclinical Cardiac Dysfunction after Bariatric Surgery.

AIMS: We aimed to gain insight into the underlying pathophysiology of cardiac dysfunction in obesity patients and the improvement of cardiac function after weight loss. METHODS: This is a longitudinal study in which 92 cardiovascular biomarkers were measured by multiplex immunoassays in obesity patients without known cardiovascular disease, before and one year after bariatric surgery. RESULTS: Out of 100 eligible patients, 72 patients completed the follow-up. A total of 72 (78%) biomarkers changed significantly. The biomarkers with the highest relative changes represented processes linked mainly to insulin resistance and inflammation. In the patients with persistent subclinical cardiac dysfunction, the baseline values of 10 biomarkers were different from values in patients with normalization of cardiac function. Most of these biomarkers were linked to inflammation or atherosclerosis. Finally, a model was developed to investigate the relationship between changes in the biomarkers and persistent subclinical cardiac dysfunction. Seven biomarkers were retained in this model, mainly linked to inflammation, atherosclerosis, and hypercoagulability. CONCLUSION: The majority (78%) of cardiovascular biomarkers changed, pointing mainly to modulation of insulin resistance and inflammation. The baseline levels of 10 biomarkers, as well as pre- to post-bariatric surgery changes in seven biomarkers, were related to persistent subclinical cardiac dysfunction after bariatric surgery.

Cognitive Behavioral Therapy Versus Usual Care Before Bariatric Surgery: One-Year Follow-Up Results of a Randomized Controlled Trial.

BACKGROUND: Although early results of bariatric surgery are beneficial for most patients, some patients regain weight later. Cognitive behavioral therapy (CBT) has been suggested as a way to improve patients' psychological health and maintaining weight loss in the longer term. The added value of preoperative CBT to bariatric surgery was examined. Pre- and posttreatment and 1-year follow-up data are presented. METHODS: In a multi-center randomized controlled trial, CBT was compared to a treatment-as-usual (TAU) control group. Measurements were conducted pre- and posttreatment/pre-surgery (T0 and T1) and at 1-year post-surgery (T2). Patients in the intervention group received 10 individual, weekly sessions of preoperative CBT focused on modifying thoughts and behaviors regarding eating behavior, physical exercise, and postoperative life style. Outcome measures included weight change, eating behavior, eating disorders, depression, quality of life, and overall psychological health. RESULTS: Though no significant differences between conditions were found per time point, in the CBT, condition scores on external eating, emotional eating, depressive symptoms, and psychological distress decreased significantly more over time between pre- (T0) and posttreatment (T1) pre-surgery compared to TAU. No significant time x condition differences were found at 1-year post-surgery (T2). CONCLUSIONS: Compared to TAU, preoperative CBT showed beneficial effects on eating behavior and psychological symptoms only from pretreatment to posttreatment/pre-surgery, but not from pre-surgery to 1-year post-surgery. Preoperative CBT does not seem to contribute to better long-term outcomes post-surgery. Recent studies suggest that the optimal time to initiate psychological treatment may be early in the postoperative period, before significant weight regain has occurred. TRIAL REGISTRATION: https://www.trialregister.nl Identifier: Trial NL3960.

Midterm Results from the Dutch Common Channel Trial (DUCATI): Superior Weight Loss Results of the Long Roux Limb Gastric Bypass in Comparison to the Standard Bypass at 3-Year Follow-Up.

In the multi-center Dutch Common Channel Trial (DUCATI), a very long Roux limb Roux-en-Y gastric bypass (VLRL-RYGB: BP-limb 60 cm, Roux limb variable, and common channel 100 cm) was compared to a standard Roux-en-Y gastric bypass (S-LRYGB: BP-limb 60 cm, Roux limb 150 cm, and common channel variable) in the treatment of morbidly obese patients. As all trial patients are beyond 3-year follow-up a midterm analysis was performed to investigate the effect of the VLRL-RYGB. METHODS: A total of 444 patients were randomized (1:1) to receive either a VLRL-RYGB or a S-LRYGB. Follow-up results for weight loss, effect on obesity-related comorbid conditions, complications, reoperation, and malnutrition are investigated. RESULTS: At 3-year follow-up a significant difference in %TWL (34.0% vs. 31.4%, p = 0.017) and %EWL (84.7% vs. 76.6%, p = 0.043) was observed in favor of VLRL-LRYGB group. Overall complication rate 3-years after surgery was 15.8% in the VLRL-LRYGB group vs. 9% in the S-LRYGB group (p = 0.031). Eight (3.6%) patients in the VLRL-LRYGB group versus 2 (0.9%) in the S-LRYGB group (p = 0.055) required revisional surgery for malabsorption. In the VLRL-LRYGB group 71.9% of patients had resolution of T2DM versus 48.9% in the S-LRYGB group (p = 0.044). CONCLUSION: At midterm FU a considerable, significantly increased effect on weight loss of the VLRL-LRYGB was observed compared to the S-LRYGB, with a higher risk of overall complications, but no significant nutritional side effects. These results might impact the current view on the value of the Roux limb in the discussion on optimum limb lengths in Roux-en-Y gastric bypass surgery.

The First Modified Delphi Consensus Statement for Resuming Bariatric and Metabolic Surgery in the COVID-19 Times.

The purpose of this study was to achieve consensus amongst a global panel of expert bariatric surgeons on various aspects of resuming Bariatric and Metabolic Surgery (BMS) during the Coronavirus Disease-2019 (COVID-19) pandemic. A modified Delphi consensus-building protocol was used to build consensus amongst 44 globally recognised bariatric surgeons. The experts were asked to either agree or disagree with 111 statements they collectively proposed over two separate rounds. An agreement amongst ≥ 70.0% of experts was construed as consensus as per the predetermined methodology. We present here 38 of our key recommendations. This first global consensus statement on the resumption of BMS can provide a framework for multidisciplinary BMS teams planning to resume local services as well as guide future research in this area.

Trial protocol: preoperative administration of tranexamic acid in sleeve gastrectomy (PATAS) to reduce haemorrhage rates. A randomised controlled trial.

INTRODUCTION: Fast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates of venous thromboembolic events (VTEs) have decreased, while there seems to be an increase in the occurrence of postoperative haemorrhage. Tranexamic acid (TXA) can potentially lower the incidence of postoperative haemorrhage. This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG). METHODS AND ANALYSIS: This is a single centre double-blind randomised placebo-controlled trial. Patients undergoing an LSG are included after obtaining informed consent. Patients are randomised between two groups: (1) administration of placebo infusion and (2) administration of 1500 mg TXA. In both groups, the infusions will be administered during the induction phase of the procedure. Primary outcome measures are preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage. Secondary outcome measure is the rates of VTE. ETHICS AND DISSEMINATION: The protocol version 3 was approved by the medical ethical committee Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 29 July 2019. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations. TRIAL REGISTRATION NUMBER: The Netherlands Trial Registry (NL8029); Pre-results.

Does the Length of the Common Channel as Part of the Total Alimentary Tract Matter? One Year Results from the Multicenter Dutch Common Channel Trial (DUCATI) Comparing Standard Versus Distal Roux-en-Y Gastric Bypass with Similar Biliopancreatic Bowel Limb Lengths.

PURPOSE: Although the laparoscopic Roux-en-Y Gastric Bypass (LRYGB) is the gold-standard bariatric procedure, it remains uncertain what the optimal bowel limb lengths are to accomplish maximal weight loss while minimizing nutritional deficiencies and related gastro-intestinal complaints. The aim of this randomized controlled multicenter trial is to investigate the effect of significant lengthening of the length of the Roux limb (RL) at the cost of the length of the common channel (CC) while keeping the biliopancreatic limb (BPL) lengths the same on both study arms. METHODS: Four hundred forty-four patients were randomized to receive either a Very Long Roux Limb LRYGB (VLRL-LRYGB) (variable RL length, BPL 60 cm, and CC 100 cm) or a Standard LRYGB (S-LRYGB) (RL 150 cm, BPL 60 cm, and a variable CC length). Results at 1-year follow-up for weight loss, effect on obesity-related comorbid conditions, complications, re-operation rate, malnutrition rate, and re-admission rate were investigated. RESULTS: Weight loss at 1-year showed no significant differences for %EWL (84.3% versus 85.3%, p = 0.72) and %TWL (34.2% versus 33.6%, p = 0.359) comparing VLRL-LRYGB versus S-LRYGB. Malabsorption requiring surgical bowel length adjustment was observed in 1.4% in VLRL-LRYGB group versus 0.9% in S-LRYGB group (p = 0.316). CONCLUSION: Significant lengthening of the RL at the cost of the common channel seems to have no effect on the weight loss at 1-year follow-up, which supports the theory that absorption of nutrients also occurs in the RL. Nevertheless, long-term results of the VLRL-LRYGB have to be awaited to draw final conclusions as part of the discussion towards optimal limb length in LRYGB surgery.

Subclinical cardiac dysfunction in obesity patients is linked to autonomic dysfunction: findings from the CARDIOBESE study.

AIMS: Obesity doubles the lifetime risk of developing heart failure. Current knowledge on the role of obesity in causing cardiac dysfunction is insufficient for optimal risk stratification. The aim of this study was first to estimate the prevalence of subclinical cardiac dysfunction in obesity patients and second to investigate the underlying pathophysiology. METHODS AND RESULTS: The CARDIOBESE study is a cross-sectional multicentre study of 100 obesity patients [body mass index (BMI) ≥ 35 kg/m2 ] without known cardiovascular disease and 50 age-matched and gender-matched non-obese controls (BMI ≤ 30 kg/m2 ). Echocardiography was performed, blood samples were collected, and a Holter monitor was affixed. Fifty-nine obesity patients [48 (42-50) years, 70% female] showed subclinical cardiac dysfunction: 57 patients had decreased global longitudinal strain (GLS), and two patients with normal GLS had either diastolic dysfunction or increased brain natriuretic peptide (BNP). Only one non-obese control had diastolic dysfunction, and none had another sign of cardiac dysfunction. Multivariable logistic analysis identified male gender and standard deviation of all NN intervals (SDNN) index, which is a measure of autonomic dysfunction, as independent significant risk factors for subclinical cardiac dysfunction in obesity patients. CONCLUSIONS: There was a high prevalence (61%) of subclinical cardiac dysfunction in obesity patients without known cardiovascular disease, which appeared to be best identified by GLS. Subclinical cardiac dysfunction in obesity was linked to autonomic dysfunction and male gender, and not to the presence of traditional cardiac risk factors, increased C-reactive protein, increased BNP, increased high-sensitivity troponin I, or increased left ventricular mass.

Structural and functional vascular improvement 1 year after bariatric surgery: a prospective cohort study.

BACKGROUND: Obesity is a major risk factor for cardiovascular disease. Data on structural and functional arterial changes after bariatric surgery are scarce. OBJECTIVES: The aim of this study was to determine the effects of bariatric surgery on the carotid intima media thickness (cIMT) and pulse wave velocity (PWV). SETTING: General hospital. METHODS: We collected data prospectively in 200 patients scheduled for bariatric surgery between 2015-2017. Based on an increase or decrease of 1 standard deviation of the mean difference in cIMT and PWV 1 year postoperatively, patients were divided into progressors, regressors', and unchanged. We analyzed data on medical history, baseline body mass index, surgery type, and difference in body mass index after 1 year. RESULTS: Data on cIMT were available for 134 patients. Thirty-four patients (25.4%) had a cIMT regression with a mean decrease of .1 mm (-.24 to -.06), 10 patients (7.5%) were progressors with a mean increase of .1 mm (.07-.30), and 90 patients (67.2%) remained unchanged. Progressors more often had type 2 diabetes (P = .035) and hypertension (P = .020). Data on PWV were available for 120 patients, of whom 91 (75.8%) were regressors, 26 (21.6%) remained unchanged, and 3 (2.5%) were progressors. Predictors of PWV changes were total plasma cholesterol and hypertension at baseline. CONCLUSIONS: A significant improvement of the vascular quality already after 1 year of follow-up was established in 25%-76% of all patients after bariatric surgery and the vast majority showed stabilization.

Cross-sectional and prospective follow-up study to detect early signs of cardiac dysfunction in obesity: protocol of the CARDIOBESE study.

INTRODUCTION: In view of the increasing occurrence of both obesity and heart failure, a growing overlap of these two clinical entities in the near future is expected. Significant advances in our understanding of the pathophysiological consequences of obesity for the cardiovascular system have been made over the past two decades. However, to optimise management and treatment of obesity patients, further research is required to improve early identification of cardiac dysfunction in obesity and to gain insight in the underlying pathophysiology. The CARdiac Dysfunction In OBesity - Early Signs Evaluation (CARDIOBESE) study has been designed to address these issues. METHODS AND ANALYSIS: CARDIOBESE is a cross-sectional multicentre study of 100 obesity patients scheduled for bariatric surgery (body mass index (BMI) ≥35 kg/m2) without known cardiovascular disease, and 50 age-matched and gender-matched non-obese controls (BMI <30 kg/m2). Echocardiography, blood and urine biomarkers and Holter monitoring will be used to identify parameters that are able to show cardiac dysfunction at a very early stage in obesity patients (primary objective). Furthermore, a prospective follow-up study of obesity patients before and 1 year after bariatric surgery will be done to gain insight in the pathophysiology of obesity causing cardiac dysfunction (secondary objective). ETHICS AND DISSEMINATION: The study was approved by the Medical Ethics Committee Toetsingscommissie Wetenschappelijk Onderzoek Rotterdam e.o. (TWOR). Inclusion of patients and controls is almost complete. Analyses of the investigations are currently being performed, and dissemination through peer-reviewed publications and conference presentations is expected from the first quarter of 2019. By identifying early markers of cardiac dysfunction in obesity, and by understanding the underlying pathophysiology of the abnormalities of these markers, the CARDIOBESE study may provide guidance for risk stratification, monitoring and treatment strategies for obesity patients.