Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial).

INTRODUCTION: By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery. METHOD AND ANALYSIS: This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: NCT05464394.

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.

The INCH-trial: a multicenter randomized controlled trial comparing short- and long-term outcomes of open and laparoscopic surgery for incisional hernia repair.

BACKGROUND: Laparoscopic incisional hernia repair is increasingly performed worldwide and expected to be superior to conventional open repair regarding hospital stay and quality of life (QoL). The INCisional Hernia-Trial was designed to test this hypothesis. METHODS: A multicenter parallel randomized controlled open-label trial with a superiority design was conducted in six hospitals in the Netherlands. Patients with primary or recurrent incisional hernias were randomized by computer-guided block-randomization to undergo either conventional open or laparoscopic repair. Primary endpoint was postoperative length of hospital stay in days. Secondary endpoints included QoL, complications, and recurrences. Patients were followed up for at least 5 years. RESULTS: Hundred-and-two patients were recruited and randomized. In total, 88 patients underwent surgery and were included in the intention-to-treat analysis (44 in the open group, 44 in the laparoscopic group). Mean age was 59.5 years, gender division was equal, and BMI was 28.8 kg/m. The trial was concluded early for futility after an unplanned interim analysis, which showed that the hypothesis needed to be rejected. There was no difference in primary outcome: length of hospital stay was 3 (range 1-36) days in the open group and 3 (range 1-12) days in the laparoscopic group (p = 0.481). There were no significant between-group differences in QoL questionnaires on the short and long term. Satisfaction was impaired in the open group. Overall recurrence rate was 19%, of which 16% in the open and 23% in the laparoscopic group (p = 0.25) at a mean follow-up of 6.6 years. CONCLUSIONS: In a randomized controlled trial, short- and long-term outcomes after laparoscopic incisional hernia repair were not superior to open surgery. The persisting high recurrence rates, reduced QoL, and suboptimal satisfaction warrant the need for patient's expectation management in the preoperative process and individualized surgical management. TRIAL REGISTRATION: Netherlands Trial Register NTR2808.

Effect of bariatric surgery on NAFLD/NASH: a single-centre observational prospective cohort study.

INTRODUCTION: The prevalence of non-alcoholic fatty liver disease (NAFLD) ranges from 25% in the general population to 90% in patients with obesity scheduled for bariatric surgery. NAFLD can progress towards non-alcoholic steatohepatitis (NASH) associated with complications such as cirrhosis, hepatocellular carcinoma and cardiovascular disease. To date, losing weight and lifestyle modifications are the best known treatments for NASH. Bariatric surgery significantly improves NAFLD/NASH in the short term. However, the extent of this improvement is not yet clear and long-term data on the natural course of NAFLD/NASH after bariatric surgery are lacking. The factors involved in NAFLD/NASH regression after bariatric surgery have not been elucidated. METHODS AND ANALYSIS: This is an observational prospective cohort study including patients scheduled for bariatric surgery. Extensive metabolic and cardiovascular analyses will be carried out including measurements of carotid intima media thickness and pulse wave velocity. Genomic, proteomic, lipidomic and metabolomic studies will be done. Microbioma analyses before and 1 year after surgery will be done. Transient elastography measurements will be performed before and at 1, 3 and 5 years after surgery. For those with an elevated preoperative transient elastography measurement by Fibroscan, a laparoscopic liver biopsy will be performed during surgery. Primary outcome measures are the change of steatosis and liver fibrosis 5 years after surgery. Secondary outcome measure is the comparison of the transient elastography measurements with the NAFLD Activity Score from the biopsies. ETHICS AND DISSEMINATION: The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 1 March 2022 (registration code R21.103/NL79423.100.21). The study results will be submitted for publication in peer-reviewed journals and data will be presented at scientific meetings. TRIAL REGISTRATION NUMBER: NCT05499949.

Evaluation of nonalcoholic fatty liver disease (NAFLD) in severe obesity using noninvasive tests and imaging techniques.

The prevalence of nonalcoholic fatty liver disease (NAFLD) and the more severe and inflammatory type, nonalcoholic steatohepatitis (NASH), is increasing rapidly. Especially in high-risk patients, that is those with obesity, metabolic syndrome, and type 2 diabetes mellitus, the prevalence of NAFLD can be as high as 80% while NASH may be present in 20% of these subjects. With the worldwide increase of obesity, it is most likely that these numbers will rise. Since advanced stages of NAFLD and NASH are strongly associated with morbidity and mortality-in particular, cardiovascular disease, liver cirrhosis, and hepatocellular carcinoma-it is of great importance to identify subjects at risk. A great variety of noninvasive tests has been published to diagnose NAFLD and NASH, especially using blood- and imaging-based tests. Liver biopsy remains the gold standard for NAFLD/NASH. This review aims to summarize the different mechanisms leading to NASH and liver fibrosis, the different noninvasive liver tests to diagnose and evaluate patients with severe obesity.

Nissen-Sleeve procedure versus laparoscopic Roux-en-Y gastric bypass in patients with morbid obesity and gastro-oesophageal reflux disease: protocol for a non-inferiority randomised trial (GINSBY).

INTRODUCTION: Laparoscopic sleeve gastrectomy (LSG) and laparoscopic Roux-en-Y gastric bypass (LRYGB) are the most frequently performed procedures in bariatric surgery. In patients with morbid obesity and gastro-oesophageal reflux disease (GORD), LRYGB is the most accepted procedure. For patients with a contraindication for LRYGB or a strong preference for LSG, the Nissen-Sleeve procedure may be a viable new option. The aim of this study is to compare effectiveness of Nissen-Sleeve with LRYGB. METHOD AND ANALYSIS: This is a single-centre, phase III, parallel-group randomised controlled trial in a high-volume bariatric centre in the Netherlands. A total of 88 patients with morbid obesity and GORD will be randomised to evaluate non-inferiority of Nissen-Sleeve versus LRYGB (non-inferiority margin 15%, power 80%, one-sided α 0.025, 9% drop out). Patients with morbid obesity aged 18 years and older with GORD according to the Montreal definition will be included after obtaining informed consent. Exclusion criteria are achalasia, neoplastic abnormalities diagnosed during endoscopy, super obesity (body mass index ≥50 kg/m2), Crohn's disease and medical history of major abdominal surgery. After randomisation, all patients will undergo an upper gastrointestinal endoscopy. Patients in the Nissen-Sleeve arm will undergo a timed barium oesophagram to exclude oesophageal motility disorders. Patients will complete six questionnaires at baseline and every year until 5 years of follow-up. At day 1 postoperative, patients in the Nissen-Sleeve arm will undergo a swallow X-ray to confirm passage. At 1 year, all patients will undergo another endoscopy. The primary outcome is GORD status. Absence of GORD is defined as <8 points on the GORD questionnaire. Secondary outcome measures are long-term GORD improvement; failure rate of procedure; health-related quality of live; weight loss; proton pump inhibitor use; postoperative complications <30 days and >30 days; length of hospital stay; duration of primary surgery; effect on comorbidities; presence and grade of oesophagitis (grade A-D) and/or presence of Barrett's oesophagus and cost-effectiveness. ETHICS AND DISSEMINATION: The protocol was approved by the Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 15 September 2021. Written informed consent will be obtained for all participants in the study. The study results will be disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: NL9789; The Netherlands Trial Registry.

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.

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.

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 .

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.

Correction to: One anastomosis gastric bypass vs. Roux-en-Y gastric bypass, remedy for insufficient weight loss and weight regain after failed restrictive bariatric surgery.

In the original article there was a discrepancy between the XML (online) version of the article and the PDF.

One anastomosis gastric bypass vs. Roux-en-Y gastric bypass, remedy for insufficient weight loss and weight regain after failed restrictive bariatric surgery.

BACKGROUND: Failure occurs in up to 60% of the patients that were treated with primary restrictive bariatric operations such as Laparoscopic Adjustable Gastric Banding (LAGB), or restrictive/metabolic operations like Laparoscopic Sleeve Gastrectomy (LSG). Insufficient weight loss and weight regain are the most commonly reported reasons of failure. The aim of this retrospective multicenter study was to compare One Anastomosis Gastric Bypass (OAGB) to Roux-en-Y Gastric Bypass (RYGB) as a revisional procedure in terms of weight loss, procedure time, complication rate and morbidity. METHODS: 491 patients operated on between 2012 and 2017 for failed restrictive surgery were included in this study (OAGB (n=185) or RYGB (n=306)). Failure was defined as total weight loss (TWL) less than 25%, excess weight loss (EWL) less than 50% and/or a remaining body mass index (BMI) larger than 40 kg/m2 at two years of follow up. Primary outcome measures were %TWL and % excess BMI loss (EBMIL) at 12, 24 and 36 months of follow-up. Secondary outcomes were procedure time, reduction of comorbidity, early and late complication rate, and mortality. RESULTS: %TWL was significantly larger in the OAGB group at 12 months (mean 24.1±9.8 vs. 21.9±9.7, p = 0.023) and 24 months (mean 23.9±11.7 vs. 20.5±11.2, p = 0.023) of follow-up. %EBMIL was significantly larger in the OAGB group at 12 months (mean 69.0±44.6 vs. 60.0±30.1, p = 0.014) and 24 months (mean 68.6±51.6 vs. 56.4±35.4, p = 0.025) of follow-up. Intra-abdominal complications (leakage, bleeding, intra-abdominal abscess and perforation) occurred less frequently after revisional OAGB (1.1% vs. 4.9%, p = 0.025). Surgical intervention for biliary reflux (5.4% vs. 0.3%, p < 0.001) was more prevalent in the OAGB group. Surgical intervention for internal herniation (0.0% vs. 4.9%, p = 0.002) was more prevalent in the RYGB group. CONCLUSIONS: This study suggests that OAGB is superior to RYGB as a remedy for insufficient weight loss and weight regain after failed restrictive surgery with more weight loss and a lower early complication rate. To substantiate these findings, further research from prospective randomized controlled trials is needed.

Effect of Roux-en-Y gastric bypass on the bioavailability of metoprolol from immediate and controlled release tablets: a single oral dose study before and after surgery.

Objective: Roux-en-Y gastric bypass (RYGB) surgery induces major changes in the gastrointestinal tract that may alter the pharmacokinetics of orally administered drugs. Results from pharmacokinetic studies are sparse. This study aimed to investigate the effect of RYGB on the bioavailability of metoprolol from immediate release (IR) and controlled release (CR) tablets in female patient volunteers before and after surgery. Methods: An explorative, two-phase, single oral dose pharmacokinetic study of metoprolol in female patients undergoing RYGB was carried out. The dose was administered twice in each patient, 1 month before and 6 months after surgery. After intake of either 100 mg of metoprolol IR or CR tablet serum concentration-time profiles of metoprolol were determined. The endpoint was the ratio of AUCafter/AUCbefore of metoprolol. Results: Twelve patients were included in the study (metoprolol IR: 7; metoprolol CR: 5). After intake of a metoprolol IR tablet major intraindividual and interindividual differences for area under the serum concentration versus time curve (AUC) of metoprolol before and after surgery were observed (range ratio AUC0-10 hours after/AUC0-10 hours before: 0.74-1.98). For metoprolol CR tablets a significant reduction in bioavailability of metoprolol was observed after surgery (range ratio AUC0-24 hours after/AUC0-24 hours before: 0.43-0.77). Conclusion: RYGB may influence the bioavailability of metoprolol from an IR tablet. The magnitude of changes in bioavailability after RYGB requires close monitoring of patients using metoprolol IR tablets and dose adjustment if deemed necessary. RYGB clearly reduces the bioavailability of metoprolol from a CR tablet. After RYGB clinicians may consider to increase the dose according to clinical response.

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.

The Dutch bariatric weight loss chart: A multicenter tool to assess weight outcome up to 7 years after sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass.

BACKGROUND: Current methods for weight loss assessment after bariatric surgery do not meet the high standards required to accurately judge patient outcome in a fair and evidence-based way. OBJECTIVES: To build an evidence-based, versatile tool to assess weight loss and weight regain and identify poor responders up to 7 years after laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic sleeve gastrectomy (LSG), for any preoperative body mass index (BMI). SETTING: Multicenter, observational study. METHODS: Bariatric weight loss charts were built with standard deviation (SD) percentile (p) curves p+2SD/p+1SD/p50(median)/p-1SD/p-2SD, based on all last measured weight results after primary LRYGB and LSG, performed in 3 large bariatric centers, expressed with percentage total weight loss (%TWL) and percentage-alterable weight loss (%AWL), a special BMI-independent metric. The p-1SD %AWL curves were compared with popular bariatric criteria 50% excess weight loss and 20%TWL. The p50 %TWL curves were compared with %TWL outcome in literature (external validation). RESULTS: In total, 9393 patients (5516 LRYGB, 3877 LSG, baseline BMI 43.7 (±SD 5.3) kg/m2, age 43 (±SD 10.9) years, 20% male, 21% type 2 diabetes) had mean follow-up 26 (range, 0-109) months, with .09% 30-day mortality. Independent outcome is presented in percentile charts for %AWL and %TWL. Percentile curves p+2SD/p+1SD/p50/p-1SD/p-2SD showed for LRYGB 72%/62%/50%/38%/28%AWL at nadir, 66%/55%/43%/30%/17%AWL at 4 years, 64%/52%/38%/25%/11%AWL at 7 years, and for LSG 69%/58%/46%/34%/22%AWL, 65%/53%/38%/23%/12%AWL, and 63%/51%/35%/22%/9%AWL, respectively. Bariatric criteria 50% excess weight loss and 20%TWL matched with most insufficient results for LSG, but not for LRYGB (low specificities). Both p50 %TWL curves are comparable with long-term weight loss in bariatric literature. CONCLUSIONS: Just as well-known growth charts are essential for pediatrics, weight loss charts should become the tools of choice for bariatrics. These multicenter charts are baseline BMI independent, superior to current bariatric criteria, and quite intuitive to use. They allow to readily detect poor responders in any postoperative phase, monitor the effect of extra counseling, judge weight regain, and manage patient expectations.

Liver failure caused by prolonged state of malnutrition following bariatric surgery.

Bariatric surgery is an effective tool in the treatment of patients with morbid obesity. In these case reports we describe 2 patients who developed liver failure after currently-practiced types of bariatric surgery, caused by a prolonged state of malnutrition provoked by psychiatric problems. Despite intensive guidance of a psychologist and dieticians after surgery, our patients deteriorated psychologically, resulting in a prolonged state of severe malnutrition and anorexia. Finally, a state of starvation was reached, passing a critical level of the liver capacity. Patients who present with signs of severe protein malnutrition after bariatric surgery should be closely monitored and checked for nutritional status. Specific attention should be given to patients who develop psychiatric problems post-bariatric surgery. If refeeding does not result in clinical improvement, reversal surgery should be considered in a timely manner.

The Standardized Postoperative Checklist for Bariatric Surgery; a Tool for Safe Early Discharge?

BACKGROUND: Morbidly obese patients are at higher risk of complications after surgery. In bariatric surgery, pre- and intra-operative checklists are commonly used to identify high-risk patients preoperatively, to decrease the number of postoperative complications. This pilot study evaluates the effect of a postoperative checklist in bariatric surgery, addressing regularly measured parameters, on the occurrence and early recognition of complications. METHODS: An in-house developed postoperative checklist was used on the first postoperative day after bariatric surgery and included information on nausea, pain, temperature, heart rate, and laboratory markers. Complications were scored using the Clavien-Dindo (CD) classification, and three groups were formed: no complications (CD0), minor complications (CD1 and 2), and major complications (≥CD3a). Differences between groups were analyzed using nonparametric tests. RESULTS: Six hundred ninety-four subjects were included (79.5% female, age 42.6 ± 10.8 years, BMI 43.8 ± 5.8 kg/m2). Twenty-nine subjects developed major complications within 30 days postoperatively. There were no significant differences in baseline characteristics between groups. Subjects with major complications were less willing to be discharged due to complaints, compared to subjects with no or minor complications (14.8 vs. 3.6 and 4.6%, respectively) and had a higher decrease of hemoglobin level (0.8 vs. 0.6 and 0.65 mmol/l, respectively). CONCLUSION: The patient's willingness for discharge, in combination with hemoglobin decrease, may be the best early predictors of major complications after bariatric surgery. This postoperative checklist may be an adequate instrument to identify patients who can be safely discharged home on the first postoperative day and thereby play a part in patient management after bariatric surgery.

Quality of Life 1 Year After Laparoscopic Sleeve Gastrectomy Versus Laparoscopic Roux-en-Y Gastric Bypass: a Randomized Controlled Trial Focusing on Gastroesophageal Reflux Disease.

INTRODUCTION: Bariatric surgery is the only treatment option that achieves sustained weight loss in obese patients and that also has positive effects on obesity-related comorbidities. Laparoscopic sleeve gastrectomy (LSG) seems to achieve equal weight loss as laparoscopic Roux-en-Y gastric bypass (LRYGB), but there is still much debate about the quality of life (QOL) after LSG, mainly concerning the association with gastroesophageal reflux. Our hypothesis is that QOL after LSG is comparable with QOL after LRYGB. MATERIALS AND METHODS: Between February 2013 and February 2014, 150 patients were randomized to undergo either LSG or LRYGB in our clinic. Differences in QOL were compared between groups by using multiple QOL questionnaires at follow-up moments preoperatively and 2 and 12 months after surgery. RESULTS: After 12 months of follow-up, 128 patients had returned the questionnaires. Most QOL questionnaires showed significant improvement in scores between the preoperative moment and after 12 months of follow-up. The Gastroesophageal Reflux Disease Questionnaire (GerdQ) score deteriorated in the LSG group after 2 months, but recovered again after 12 months. After 2 months of follow-up, the mean GerdQ score was 6.95 ± 2.14 in the LSG group versus 5.50 ± 1.49 in the LRYGB group (p < 0.001). After 1 year, the mean GerdQ score was 6.63 ± 2.26 in the LSG group and 5.60 ± 1.07 in the LRYGB group (p = 0.001). CONCLUSION: This randomized controlled trial shows that patients who underwent LSG have significantly higher GerdQ scores at both 2 and 12 months postoperatively than patients who underwent LRYGB, whereas overall QOL did not differ significantly.

Influence of bariatric surgery on the use of medication.

PURPOSE: Bariatric surgery can influence the prevalence and incidence of comorbidities, as well as the pharmacokinetics of drugs. This might lead to changes in the use of drugs. This study aimed to assess the influence of bariatric surgery on the use of medication in patients before and after surgery, focusing on type, number of medications, and daily dosage. METHODS: In a retrospective and prospective observational study, drug dispensing data from pharmacies of patients undergoing their first bariatric surgery between January 2008 and September 2011 was collected. Dispensing data from 1 month before until 12 months after surgery was analyzed. Drugs were classified according to the WHO-ATC classification system. Dosages of drugs were compared using defined daily dose (DDD). RESULTS: Among 450 patients, 12 months after surgery, the mean number of drugs per patient for antidiabetics, drugs acting on the cardiovascular system, anti-inflammatory and antirheumatic drugs, and drugs for obstructed airway diseases decreased by, respectively, 71.3 % (95 % CI 57.2 to 85.4), 34.5 % (95 % CI 28.2 to 43.0), 45.5 % (95 % CI 13.3 to 72.6), and 33.1 % (95 % CI 15.3 to 53.2). Patients used lower median DDD of oral antidiabetics, beta-blocking agents, and lipid-modifying drugs. CONCLUSIONS: For some major drug classes 12 months after bariatric surgery, the use of drugs decreases in terms of mean number per patient. A reduction in dose intensity was observed for oral antidiabetics, beta-blocking agents, and lipid-modifying drugs. Dispensing data from pharmacies may provide detailed information on the use of medications by patients after bariatric surgery.

Efficacy of Bariatric Surgery in Type 2 Diabetes Mellitus Remission: the Role of Mini Gastric Bypass/One Anastomosis Gastric Bypass and Sleeve Gastrectomy at 1 Year of Follow-up. A European survey.

BACKGROUND: A retrospective study was undertaken to define the efficacy of both mini gastric bypass or one anastomosis gastric bypass (MGB/OAGB) and sleeve gastrectomy (SG) in type 2 diabetes mellitus (T2DM) remission in morbidly obese patients (pts). METHODS: Eight European centers were involved in this survey. T2DM was preoperatively diagnosed in 313/3252 pts (9.62%). In 175/313 patients, 55.9% underwent MGB/OAGB, while in 138/313 patients, 44.1% received SG between January 2006 and December 2014. RESULTS: Two hundred six out of 313 (63.7 %) pts reached 1 year of follow-up. The mean body mass index (BMI) for MGB/OAGB pts was 33.1 ± 6.6, and the mean BMI for SG pts was 35.9 ± 5.9 (p < 0.001). Eighty-two out of 96 (85.4%) MGB/OAGB pts vs. 67/110 (60.9%) SG pts are in remission (p < 0.001). No correlation was found in the % change vs. baseline values for hemoglobin A1c (HbA1c) and fasting plasma glucose (FPG) in relation to BMI reduction, for both MGB/OAGB or SG (ΔFPG 0.7 and ΔHbA1c 0.4 for MGB/OAGB; ΔFPG 0.7 and ΔHbA1c 0.1 for SG). At multivariate analysis, high baseline HbA1c [odds ratio (OR) = 0.623, 95% confidence interval (CI) 0.419-0.925, p = 0.01], preoperative consumption of insulin or oral antidiabetic agents (OR = 0.256, 95% CI 0.137-0.478, p = <0.001), and T2DM duration >10 years (OR = 0.752, 95% CI 0.512-0.976, p = 0.01) were negative predictors whereas MGB/OAGB resulted as a positive predictor (OR = 3.888, 95% CI 1.654-9.143, p = 0.002) of diabetes remission. CONCLUSIONS: A significant BMI decrease and T2DM remission unrelated from weight loss were recorded for both procedures if compared to baseline values. At univariate and multivariate analyses, MGB/OAGB seems to outperform significantly SG. Four independent variables able to influence T2DM remission at 12 months have been identified.