Cost-effectiveness of the RefluxStop device for management of refractory gastroesophageal reflux disease in Switzerland.

BACKGROUND: One of the most prevalent conditions in Western societies is gastroesophageal reflux disease (GERD). In Switzerland, the standard treatment for GERD is proton pump inhibitor (PPI)-based medical management, but surgical options such as Nissen fundoplication and magnetic sphincter augmentation (MSA) are available. RefluxStop is a novel device that offers an alternative solution. The purpose of this report is to evaluate the cost-effectiveness of RefluxStop compared to PPIs and existing surgical treatments. METHODS: A model (Markov) was developed using the Swiss healthcare payer perspective with a lifetime horizon, 1-month cycle length, and a 3% annual discount rate for costs and benefits. Adverse events specific to treatment arms were incorporated, and benefits were measured in quality-adjusted life-years (QALYs). Clinical efficacy data for RefluxStop was obtained from its CE mark study, and comparator treatments were based on published literature. Deterministic and probabilistic sensitivity analyses were used to explore uncertainty. Since there are no head-to-head studies between RefluxStop and PPI therapy, Nissen fundoplication, or MSA, a limitation of this study is the use of naïve, indirect comparison of clinical effectiveness between the studied treatment options. RESULTS: Higher QALYs and lower costs were provided by RefluxStop compared to Nissen fundoplication and the MSA system. The incremental cost-effectiveness ratio (ICER) for RefluxStop was CHF 2,116 in comparison to PPI-based medical management. At a cost-effectiveness threshold of CHF 100,000 per QALY gained, the probability of RefluxStop being cost-effective was high, with probabilities of 100%, 97%, and 100% against PPI-based medical management, Nissen fundoplication, and MSA, respectively. The robustness of the analysis was provided by deterministic and probabilistic sensitivity analyses. CONCLUSION: This cost-effectiveness analysis demonstrates that there is a high likelihood of RefluxStop being a cost-effective treatment modality in adults with GERD when compared with other treatment options available in Switzerland.

Gastroesophageal reflux disease (GERD) is one of the most prevalent conditions in Western societies. Standard treatment in Switzerland entails proton pump inhibitor (PPI)-based medical management or surgical options (i.e., Nissen fundoplication and magnetic sphincter augmentation [MSA]) in selected cases. RefluxStop is a new technology indicated for the surgical treatment of GERD that restores the normal anatomy of the anti-reflux barrier. The clinical benefits and monetary costs of RefluxStop must be weighed against available treatment options to determine the role of this new technology in Switzerland. Cost-effectiveness analyses compare the relative costs and clinical outcomes of disease management when pursuing different paths in the patient journey landscape, as measured by quality-adjusted life-years (QALYs). In the present study, RefluxStop in comparison to Nissen fundoplication, and MSA, provided higher QALYs and lower costs. Against PPI therapy, the costs were slightly higher but the QALYs were also higher, generating a favourable Incremental cost-effectiveness ratio. Furthermore, at the cost-effectiveness threshold of CHF 100,000 per QALY gained, RefluxStop was highly likely to be cost-effective in comparison to PPI therapy, Nissen fundoplication, and MSA with probabilities of 100%, 97%, and 100%, respectively. Ultimately, this cost-effectiveness analysis showed that RefluxStop has a high likelihood of cost-effectiveness as a GERD treatment in Switzerland against other treatment options, with results being robust even with uncertainties considered in additional sensitivity analyses.

Efficacy and Safety of Rivaroxaban for Postoperative Thromboprophylaxis in Patients After Bariatric Surgery: A Randomized Clinical Trial.

Importance: Venous thromboembolism (VTE) is a leading cause of morbidity and mortality after bariatric surgery. Clinical end point studies on thromboprophylaxis with direct oral anticoagulants in patients undergoing bariatric surgery are lacking. Objective: To assess the efficacy and safety of a prophylactic dose of 10 mg/d of rivaroxaban for both 7 and 28 days after bariatric surgery. Design, Setting, and Participants: This assessor-blinded, phase 2, multicenter randomized clinical trial was conducted from July 1, 2018, through June 30, 2021, with participants from 3 academic and nonacademic hospitals in Switzerland. Intervention: Patients were randomized 1 day after bariatric surgery to 10 mg of oral rivaroxaban for either 7 days (short prophylaxis) or 28 days (long prophylaxis). Main Outcomes and Measures: The primary efficacy outcome was the composite of deep vein thrombosis (symptomatic or asymptomatic) and pulmonary embolism within 28 days after bariatric surgery. Main safety outcomes included major bleeding, clinically relevant nonmajor bleeding, and mortality. Results: Of 300 patients, 272 (mean [SD] age, 40.0 [12.1] years; 216 women [80.3%]; mean body mass index, 42.2) were randomized; 134 received a 7-day and 135 a 28-day VTE prophylaxis course with rivaroxaban. Only 1 thromboembolic event (0.4%) occurred (asymptomatic thrombosis in a patient undergoing sleeve gastrectomy with extended prophylaxis). Major or clinically relevant nonmajor bleeding events were observed in 5 patients (1.9%): 2 in the short prophylaxis group and 3 in the long prophylaxis group. Clinically nonsignificant bleeding events were observed in 10 patients (3.7%): 3 in the short prophylaxis arm and 7 in the long prophylaxis arm. Conclusions and Relevance: In this randomized clinical trial, once-daily VTE prophylaxis with 10 mg of rivaroxaban was effective and safe in the early postoperative phase after bariatric surgery in both the short and long prophylaxis groups. Trial Registration: ClinicalTrials.gov Identifier: NCT03522259.

Gastroesophageal Junction and Pylorus Distensibility Before and After Sleeve Gastrectomy-pilot Study with EndoFlipTM.

Sleeve gastrectomy (SG) is the most frequently performed bariatric surgical intervention worldwide. Gastroesophageal reflux disease (GERD) is frequently observed after SG and is a relevant clinical problem. This prospective study investigated the gastroesophageal junction (GEJ) and pyloric sphincter by impedance planimetry (EndoFlipTM) and their association with GERD at a tertiary university hospital center. Between January and December 2018, patients undergoing routine laparoscopic SG had pre-, intra-, and postoperative assessments of the GEJ and pyloric sphincter by EndoFlipTM. The distensibility index (DI) was measured at different volumes and correlated with GERD (in accordance with the Lyon consensus guidelines). Nine patients were included (median age 48 years, preoperative BMI 45.1 kg/m2, 55.6% female). GERD (de novo or stable) was observed in 44.4% of patients one year postoperatively. At a 40-ml filling volume, DI increased significantly pre- vs. post-SG of the GEJ (1.4 mm2/mmHg [IQR 1.1-2.6] vs. 2.9 mm2/mmHg [2.6-5.3], p VALUE=0.046) and of the pylorus (6.0 mm2/mmHg [4.1-10.7] vs. 13.1 mm2/mmHg [7.6-19.2], p VALUE=0.046). Patients with postoperative de novo or stable GERD had a significantly increased preoperative DI at 40 ml of the GEJ (2.6 mm2/mmHg [1.9-3.5] vs. 0.5 mm2/mmHg [0.5-1.1], p VALUE=0.031). There was no significant difference in DI at 40 mL filling in the preoperative pylorus and postoperative GEJ or pylorus. In this prospective study, the DI of the GEJ and the pylorus significantly increased after SG. Postoperative GERD was associated with a significantly higher preoperative DI of the GEJ but not of the pylorus.

RefluxStop™ Therapy - a New Minimally Invasive Technology in Anti-reflux Surgery.

The symptoms of gastroesophageal reflux disease (GERD) are very common, but cannot be reliably controlled with medication, as more than 40% of patients suffer troublesome symptoms more than twice a week even when taking maximum doses of proton pump inhibitors (PPI). Until recently, the only surgical option was anti-reflux surgery, usually performed as a hiatal hernia repair and some form of fundoplication. While this is still the gold standard, some centers note high recurrence rates and/or high rates of side effects such as dysphagia, bloating, and post-prandial discomfort. This paper describes a new surgical procedure that controls reflux symptoms through hiatal hernia repair in combination with the implantation of a silicone cube. The cube is implanted near the left side of the esophagus above the lower esophageal sphincter (LES). The details of the procedure, the indications for this new approach, the initial results, and the rate of side effects compared to Nissen fundoplication are described. Implantation of the CE-certified RefluxStop™ (Implantica, Zug, Switzerland) has been used for 3 years and the initial studies show encouraging success rates. In addition, side effects are significantly reduced. These results must be evaluated in further studies.

Vacuum-Sponge Therapy Placed through a Percutaneous Gastrostomy to Treat Spontaneous Duodenal Perforation.

Duodenal perforation is rare and associated with a high mortality. Therapeutic strategies to address duodenal perforation include conservative, surgical, and endoscopic measures. Surgery remains the gold standard. However, endoscopic management is gaining ground mostly with the use of over-the-scope clips and vacuum-sponge therapy. A 67-year-old male patient was admitted to the emergency room for persistent epigastric pain, melena, and signs of sepsis. The physical assessment revealed reduced bowel sounds, involuntary guarding, and rebound tenderness in the upper abdominal quadrant. A contrast-enhanced computed tomography (CT) scan confirmed the suspicion of ulcer perforation. The initial laparoscopic surgical approach required conversion to laparotomy with overstitching of the perforation. In the postoperative course, the patient developed signs of increased inflammation and dyspnea. A CT scan and an endoscopy revealed a postoperative leakage and pneumonia. We placed an endoscopic duodenal intraluminal vacuum-sponge therapy with endoscopic negative pressure for 21 days. The leakage healed and the patient was discharged. Most experience in endoscopic vacuum-sponge therapy for gastrointestinal perforations has been gained in the area of esophageal and rectal transmural defects, whereas only few reports have described its use in duodenal perforations. In our case, the need for further surgical management could be avoided in a patient with multiple comorbidities and a reduced clinical status. Moreover, the pull-through technique via PEG for sponge placement reduces the intraluminal distance of the Eso-Sponge tube by shortcutting the length of the esophagus, thus decreasing the risk of dislocation and increasing the chance of successful treatment.

Case Report: Modified Thoracoscopic-Assisted Cervical Resection for Retrosternal Goiter.

Introduction: The treatment of choice for retrosternal goiters (RSG) is surgical resection to relieve symptoms and rule out malignancy. Although the majority of RSG can be removed by a cervical approach only, an extracervical approach (e.g., sternotomy, thoracotomy or thoracoscopy) may be required. Herein, we describe a refined thoracoscopic-assisted cervical two-team RSG resection without thoracoscopic mediastinal dissection. Technique: A 57-year-old man presented with a large RSG with posterior mediastinal extension (PME) and extensive peritumoral vascularization. Due to its extension below the aortic arch and its small connection with the right thyroid lobe, a combined cervical and thoracoscopic approach was intended. The endocrine surgery unit performed the cervical mobilization of the right thyroid lobe, while the thoracic surgery unit gently pushed the mediastinal tumor through the thoracic inlet without performing mediastinal dissection. This allowed a safe visualization of the inserting vessels by the endocrine surgery team at the neck, followed by a stepwise division of the vessels and resection of the retrosternal nodule through the cervical access. Comment: The described approach is indicated for RSG with posterior mediastinal extension, anteroposterior dimension smaller than the thoracic inlet and inaccessibility from a cervical approach only. This minimally invasive approach is associated with a faster recovery, decreased morbidity and postoperative pain, shorter hospital stay and better cosmetic results.

Ulcer Disease in the Excluded Segments after Roux-en-Y Gastric Bypass: a Current Review of the Literature.

Ulcer disease in excluded segments after Roux-Y gastric bypass (RYGB) is rare but can evolve into a life-threatening situation. The excluded segments exhibit a different behavior from that of non-altered anatomy; perforated ulcers do not result in pneumoperitoneum or free fluid, and therefore must be met with a low threshold for surgical exploration. The anatomical changes after RYGB impede routine access to the remnant stomach and duodenum. There are various options to address bleeding or perforated ulcers. While oversewing and drainage preserves the anatomy and forgoes resection, remnant gastrectomy offers a definitive solution. The importance of traditional risk factors such as smoking or use of non-steroidal anti-inflammatory drugs is unclear. Eradication of Helicobacter pylori and secondary prophylaxis with proton-pump inhibitors is advisable, albeit in double-dose.

Favourable long-term survival of patients with esophageal cancer treated with extended transhiatal esophagectomy combined with en bloc lymphadenectomy: results from a retrospective observational cohort study.

BACKGROUND: Although considered complex and challenging, esophagectomy remains the best potentially curable treatment option for resectable esophageal and esophagogastric junction (AEG) carcinomas. The optimal surgical approach and technique as well as the extent of lymphadenectomy, particularly regarding quality of life and short- and long-term outcomes, are still a matter of debate. To lower perioperative morbidity, we combined the advantages of a one-cavity approach with extended lymph node dissection (usually achieved by only a two-cavity approach) and developed a modified single-cavity transhiatal approach for esophagectomy. METHODS: The aim of this study was to evaluate the outcome of an extended transhiatal esophageal resection with radical bilateral mediastinal en bloc lymphadenectomy (eTHE). A prospective database of 166 patients with resectable cancers of the esophagus (including adenocarcinomas of the AEG types I and II) were analyzed. Patients were treated between 2001 and 2017 with eTHE at a tertiary care university center. Relevant patient characteristics and outcome parameters were collected and analyzed. The primary endpoint was 5-year overall survival. Secondary outcomes included short-term morbidity, mortality, radicalness of en bloc resection and oncologic efficacy. RESULTS: The overall survival rates at 1, 3 and 5 years were 84, 70, and 61.0%, respectively. The in-hospital mortality rate after eTHE was 1.2%. Complications with a Clavien-Dindo score of III/IV occurred in 31 cases (18.6%). A total of 25 patients (15.1%) had a major pulmonary complication. The median hospital stay was 17 days (interquartile range (IQR) 12). Most patients (n = 144; 86.7%) received neoadjuvant treatment. The median number of lymph nodes resected was 25 (IQR 17). The R0 resection rate was 97%. CONCLUSION: In patients with esophageal cancer, eTHE without thoracotomy resulted in excellent long-term survival, an above average number of resected lymph nodes and an acceptable postoperative morbidity and mortality.

Tailored access to the hepatobiliary system in post-bariatric patients: a tertiary care bariatric center experience.

BACKGROUND: In bariatric surgery patients, pancreaticobiliary access via endoscopic retrograde cholangiopancreatography (ERCP) is technically challenging and the optimal approach for the evaluation and treatment of biliary tree-related pathologies has been debated. Besides laparoscopy-assisted ERCP (LA-ERCP) as standard of care, EUS-directed transgastric ERCP (EDGE) and hepaticogastrostomy (HGS) with placement of a fully covered metal stent have emerged as novel techniques. The objective of this study was to evaluate safety and efficacy of three different endoscopic approaches (LA-ERCP, EDGE, and HGS) in bariatric patients. METHODS: In this retrospective review, consecutive patients with Roux-en-Y gastric bypass (RYGB) and Sleeve Gastrectomy (SG) who underwent from 2013 to 2019 a LA-ERCP, an EDGE, or a HGS at a tertiary care reference center for bariatric surgery were analyzed. Patient demographics, type of procedure and indication, data regarding cannulation and therapeutic intervention of the common bile duct (procedure success), and clinical outcomes were analyzed. RESULTS: A total of 19 patients were included. Indications for LA-ERCP, EDGE, or HGS were mostly choledocholithiasis (78.9%) and in a few cases papillitis stenosans. Eight patients (57.1%) with LA-ERCP underwent concomitant cholecystectomy. Procedure success was achieved in 100%. Adverse events (AEs) were identified in 15.7% of patients (all ERCP related). All AEs were rated as moderate and there were no serious AEs. CONCLUSION: This case series indicates that ERCP via a transgastric approach (LA-ERCP, EDGE, or HGS) is a minimally invasive, effective, and feasible method to access the biliary tree in bariatric patients. These techniques offer an appealing alternative treatment option compared to percutaneous transhepatic cholangiography and drainage- or deep enteroscopy-assisted ERCP. In bariatric patients who earlier had a cholecystectomy, EUS-guided techniques were the preferred treatment options for biliary pathologies.

De novo gastroesophageal reflux disease after sleeve gastrectomy: role of preoperative silent reflux.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) has become the most frequently performed bariatric procedure to date. However, LSG is known to worsen pre-operative and result in de novo gastroesophageal reflux disease (GERD). Pre-operative evaluation reveals a high percentage of silent GERD of so far unknown influence on post-operative GERD. METHODS: Prospective data of patients undergoing primary LSG between 01/2012 and 12/2015 were evaluated. Pre-operative GERD-specific evaluation consisted of validated questionnaires, upper endoscopy, 24 h-pH-manometry, and esophagograms. Patients were followed-up with questionnaires every 6 months, upper endoscopies after 1 year and 24 h-pH-metry after 2 years. Silent GERD was defined as esophagitis grade > B and/or abnormal esophageal acid exposure in absence of symptoms. LSG was performed over a 32F bougie, hiatal hernias > 1 cm were addressed with posterior hiatoplasty. Excluded were patients with hiatal hernias > 4 cm, patients with incorrect anatomy (stenosis, fundus too large) and conversion to RYGB for early leaks. RESULTS: 222 patients were included. Mean follow-up was 32 ± 16 months, mean preoperative body mass index 49.6 ± 7.2 kg/m2. 116 patients (52%) presented with post-operative GERD-symptoms, of which 85 (73%) had de novo symptoms. Of those, 48 (of 85, 56%) had no preoperative GERD and 37 (of 85, 44%) silent GERD. 57 patients (26%) had neither pre- nor post-operative GERD, 7 (3%) had silent pre-operative and no postop GERD, and in 19 patients (9%) GERD was cured with LSG. 31 patients (14%) stayed symptomatic. Of 56 patients (25%) with pre-operative silent GERD, 37 (of 54, 66%) became symptomatic. CONCLUSION: LSG leads to a considerable rate of post-operative GERD. De novo-GERD consist of around half of pre-operative silent GERD and completely de novo-GERD. Most patients with pre-operative silent GERD became symptomatic.

Mental Illness Has a Negative Impact on Weight Loss in Bariatric Patients: a 4-Year Follow-up.

BACKGROUND: Mental health disorders are highly prevalent among bariatric surgery patients. Bariatric surgery induces weight loss with continuous health improvements. However, long-term follow-up data on weight loss and quality of life data of patients who have a mental illness after bariatric surgery are scarce, and it is not clear whether mental illness is associated with more pronounced weight regain. The aim was to investigate the impact of preoperative mental illness on the course of long-term weight changes after bariatric surgery. METHODS: Patients with sleeve gastrectomy (SG) or Roux-en-Y gastric bypass surgery (RYGB) between 2005 and 2013 with a follow-up of at least 3 years were included. The study population was divided into two groups: patients with mental illness (MI) and patients without (No-MI). Weight loss outcomes over time were compared using mixed models up to 4 years after surgery. RESULTS: In total, 254 patients (RYGB 61.0%, SG 39%) were included. The distribution of baseline characteristics was similar between the MI (n = 108) and No-MI groups (n = 146). The most prevalent mental illness was depressive disorder (63.9%). In the MI group, the percent of total weight loss (%TWL) was significantly smaller over the study period. After 36 months, the predicted mean group-difference of %TWL was 4.6% (95% CI 1.9, 7.2; p = 0.001), and the predicted odds ratio for weight regain was 4.9 (95% CI 1.6, 15.1) for patients in the MI group. CONCLUSION: Preoperative mental illness leads to lower long-term weight loss and an increased risk of weight regain after bariatric surgery.

The effect of bariatric surgery on the direct oral anticoagulant rivaroxaban: the extension study.

BACKGROUND: Thromboembolic disease is a potentially serious complication in bariatric surgery patients. Direct oral anticoagulants (DOAC) have been investigated in orthopedic surgery patients. DOAC data after bariatric surgery are still limited to the early postsurgical period. Whether postsurgical midterm adaptations due to anatomic and physiologic alterations influence drug pharmacology is currently not known. OBJECTIVE: The aim of this study was to investigate the influence of weight loss and type of bariatric surgery on midterm postsurgical pharmacokinetic and pharmacodynamic parameters of rivaroxaban. SETTING: University hospital. METHODS: In this monocentric study, bariatric patients received a single oral dose of rivaroxaban (10 mg) 6 to 8 months after sleeve gastrectomy (SG) or Roux-en-Y-gastric bypass (RYGB). Pharmacokinetic and pharmacodynamic parameters were assessed and compared with prebariatric surgery results. RESULTS: We included 6 RYGB and 6 SG patients. Percent excess weight loss was 71.4% (interquartile range 56.4, 87.9) in the SG group and 76.6% (64.5, 85.7) in the RYGB group. Rivaroxaban mean areas under the curve 6 to 8 months after the bariatric procedure (922.4 µg × h/L, coefficient of variation 43.2) were comparable to those measured preoperatively (952.6 µg × h/L, 16.8). There was no relevant difference between the 2 surgical procedure groups. Rivaroxaban led to a decrease of prothrombin fragments F1+2 over 12 hours after oral intake confirming in vivo efficacy. CONCLUSIONS: Significant weight loss and altered anatomy after RYGB and SG procedures do not appear to affect the pharmacokinetics and pharmacodynamics of prophylactic rivaroxaban. A single dose of Rivaroxaban was well tolerated and considered safe in this trial.

Perforated duodenal ulcers after Roux-Y Gastric Bypass.

Even though the incidence of complicated peptic ulcer disease (PUD) has decreased in the last decades, it remains a condition with a significant mortality. Whilst diagnosis and treatment of PUD in morbidly obese patients can be challenging, patients with excluded segments - such as after Roux-Y Gastric Bypass (RYGB) - present an even greater problem, as the subsequent altered anatomy impedes the common modalities used for diagnostic and therapeutic measures. We report the cases of two patients after RYGB with perforated duodenal ulcers in the intention to highlight problems regarding diagnosis and treatment. Patients with perforation after RYGB usually present without signs of hollow organ perforation in clinical examination but also in computed tomography scans. Diagnostic laparoscopy was performed to address the discrepancy between pain and non-diagnostic examinations. An aggressive approach in case of unexplained symptoms in these patients is not only justified but mandatory.

C-Reactive Protein on Postoperative Day 1: a Predictor of Early Intra-abdominal Infections After Bariatric Surgery.

BACKGROUND: Early intra-abdominal infections (IAI) compromise short-term outcomes in bariatric surgery. The timely detection of IAI is challenging but essential to prevent major sequelae of such complications. C-reactive protein (CRP) is a reliable marker for detecting IAI after colorectal surgery. In bariatric surgery, data on CRP as a marker for IAI are limited, particularly for postoperative day one (POD1). OBJECTIVE: The objective of this study was to assess CRP on POD1 as a predictor for early IAI (within 7 days following surgery) in patients after laparoscopic sleeve gastrectomy (LSG) and Roux-en-Y gastric bypass (LRYGB). METHODS: Patients with bariatric surgery between 08/2010 and 06/2017 were included. The predictive capacity of CRP for early IAI was determined using a receiver operating characteristics (ROC) analysis. RESULTS: In 523 patients (68.5% female, LSG = 358, LRYGB = 165), 16 (3%) early IAI were observed. ROC analysis revealed a significant predictive capacity of POD1 CRP for early IAI, with a sensitivity and a specificity of 81.2 and 94.3%, respectively, at a CRP cut-off value of 70 mg/L. In patients with confirmed early IAI, 81.3% had a CRP level ≥ 70 mg/L (LSG 85.7%, LRYGB 77.8%). The negative predictive value for a CRP level < 70 mg/L was 99.4% overall and was 100 and 98% for LSG and LRYGB, respectively. CONCLUSION: In patients with a CRP level < 70 mg/L on POD1, early IAI can be excluded with high accuracy in bariatric patients. Thus, early postoperative CRP may be used to assess the risk of early IAI in enhanced recovery programs.

Radiologic, endoscopic, and functional patterns in patients with symptomatic gastroesophageal reflux disease after Roux-en-Y gastric bypass.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) is considered the gold standard in treatment of morbid obesity and gastroesophageal reflux disease (GERD). Resolution of GERD symptoms is reported to be approximately 85% to 90%. OBJECTIVE: To evaluate patients with persistent GERD symptoms after RYGB and to identify contributing factors. SETTING: University hospital, cross-sectional study. METHODS: Data of patients evaluated for persistent GERD with a history of RYGB between January 2012 and December 2015 were reviewed. GERD was assessed with questionnaires, endoscopy, 24-hour pH-impendance manometry, and barium swallow. RESULTS: Of 47 patients, 44 (93.6%) presented with typical GERD, 18 (38.3%) with obstruction, 8 (17%) with pulmonary symptoms, and 21 (44.7%) with pain. The interval between RYGB and evaluation was a median of 3.8 years (range .8-12.6); median patient age was 36.5 years (19.1-67.2). Median body mass index was 30.3 kg/m2 (20.3-47.2). Pouch gastric fistulas were seen in 2 (5.1%), enlarged pouches in 5 (10.6%), and hiatal hernias in 25 patients (53.2%). Twelve (23.4%) had esophagitis>Los Angeles (LA) grade B. Manometry was performed in 45 (95.7%) and off-proton pump inhibitor 24-hour pH-impedance-metry in 44 patients (94.6%). Seventeen patients (37.8%) had esophageal hypomotility or aperistalsis; hypotensive lower esophageal sphincter was seen in 26 patients (57.8%). Increased esophageal acid exposure (>4% pH<4) was found in 27 (61.4%), an increased number of reflux episodes (>53) in 30 patients (68.2%). Symptoms were deemed as functional in 6 (12.8%). CONCLUSION: The evaluation for persistent GERD after RYGB revealed a high percentage of hiatal hernias, hypotensive lower esophageal sphincter, and severe esophageal motility disorders. These findings might have an influence on hiatal hernia closure concomitant with RYGB and the role of pH manometry in the preoperative bariatric assessment.

Electrical stimulation of the lower esophageal sphincter to address gastroesophageal reflux disease after sleeve gastrectomy.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) can result in de novo and worsen preexisting gastroesophageal reflux disease (GERD). Post-LSG patients with GERD refractory to proton pump inhibitors (PPI) usually undergo more invasive, anatomy-altering Roux-en-Y gastric bypass surgery. Lower esophageal sphincter (LES) electrical stimulation (ES) preserves the anatomy and has been shown to improve outcomes in GERD patients. OBJECTIVE: To evaluate the safety and efficacy of LES-ES in post-LSG patients with GERD not controlled with maximal PPI therapy. SETTING: Prospective, international, multicenter registry. METHODS: Patients with LSG-associated GERD partially responsive to PPI underwent LES-ES. GERD outcomes pre- and poststimulation were evaluated based on quality of life, esophageal acid exposure (after 6-12 mo), and PPI use. RESULTS: Seventeen patients (11 female, 65%), treated at 6 centers between May 2014 and October, 2016 with a median follow-up of 12 months (range 6-24), received LES-ES. Median age was 48.6 years (interquartile range, 40.5-56), median body mass index 31.7 kg/m2 (27.9-39.3). All patients were on at least daily PPI preoperatively; at last follow-up, 7 (41%) were completely off PPI, 5 (29%) took PPI on an intermittent basis, and 5 (29%) were on single-dose PPI. Median GERD-health-related quality of life scores improved from 34 (on-PPI, 25-41) at baseline to 9 (6-13) at last follow-up (off-PPI, P<.001). Percentage of time with esophageal pH<4 improved from 13.2% (3.7-30.7) to 5.8% (1.1-54.4), P = .01. CONCLUSION: LES-ES in post-LSG patients suffering from symptomatic, PPI-refractory GERD resulted in significant improvement of GERD-symptoms, esophageal acid exposure, and need for PPI. Preserving the post-LSG anatomy, it offers a valid option for patients unable or unwilling to undergo Roux-en-Y gastric bypass surgery.

Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity: The SM-BOSS Randomized Clinical Trial.

Importance: Sleeve gastrectomy is increasingly used in the treatment of morbid obesity, but its long-term outcome vs the standard Roux-en-Y gastric bypass procedure is unknown. Objective: To determine whether there are differences between sleeve gastrectomy and Roux-en-Y gastric bypass in terms of weight loss, changes in comorbidities, increase in quality of life, and adverse events. Design, Setting, and Participants: The Swiss Multicenter Bypass or Sleeve Study (SM-BOSS), a 2-group randomized trial, was conducted from January 2007 until November 2011 (last follow-up in March 2017). Of 3971 morbidly obese patients evaluated for bariatric surgery at 4 Swiss bariatric centers, 217 patients were enrolled and randomly assigned to sleeve gastrectomy or Roux-en-Y gastric bypass with a 5-year follow-up period. Interventions: Patients were randomly assigned to undergo laparoscopic sleeve gastrectomy (n = 107) or laparoscopic Roux-en-Y gastric bypass (n = 110). Main Outcomes and Measures: The primary end point was weight loss, expressed as percentage excess body mass index (BMI) loss. Exploratory end points were changes in comorbidities and adverse events. Results: Among the 217 patients (mean age, 45.5 years; 72% women; mean BMI, 43.9) 205 (94.5%) completed the trial. Excess BMI loss was not significantly different at 5 years: for sleeve gastrectomy, 61.1%, vs Roux-en-Y gastric bypass, 68.3% (absolute difference, -7.18%; 95% CI, -14.30% to -0.06%; P = .22 after adjustment for multiple comparisons). Gastric reflux remission was observed more frequently after Roux-en-Y gastric bypass (60.4%) than after sleeve gastrectomy (25.0%). Gastric reflux worsened (more symptoms or increase in therapy) more often after sleeve gastrectomy (31.8%) than after Roux-en-Y gastric bypass (6.3%). The number of patients with reoperations or interventions was 16/101 (15.8%) after sleeve gastrectomy and 23/104 (22.1%) after Roux-en-Y gastric bypass. Conclusions and Relevance: Among patients with morbid obesity, there was no significant difference in excess BMI loss between laparoscopic sleeve gastrectomy and laparoscopic Roux-en-Y gastric bypass at 5 years of follow-up after surgery. Trial Registration: clinicaltrials.gov Identifier: NCT00356213.

Diarrhea after bariatric procedures: Diagnosis and therapy.

Diarrhea after bariatric procedures, mainly those with malabsorptive elements including Roux-Y Gastric Bypass and Biliopancreatic Diversion, is common and an essential determinant of quality of life and micro- and macronutrient deficiencies. Bariatric surgery is the only sustainably successful method to address morbid obesity and its comorbidities, particularly gaining more and more importance in the specific treatment of diabetic patients. Approximately half a million procedures are annually performed around the world, with numbers expected to rise drastically in the near future. A multitude of factors exert their influence on bowel habits; preoperative comorbidities and procedure-related aspects are intertwined with postoperative nutritional habits. Diagnosis may be challenging owing to the characteristics of post-bariatric surgery anatomy with hindered accessibility of excluded segments of the small bowel and restriction at the gastric level. Conventional testing measures, if available, generally yield low accuracy and are usually not validated in this specific population. Limited trials of empiric treatment are a practical alternative and oftentimes an indispensable part of the diagnostic process. This review provides an overview of causes for chronic post-bariatric surgery diarrhea and details the particularities of its diagnosis and treatment in this specific patient population. Topics of current interest such as the impact of gut microbiota and the influence of bile acids on morbid obesity and especially their role in diarrhea are highlighted in order to provide a better understanding of the specific problems and chances of future treatment in post-bariatric surgery patients.

Symptoms, endoscopic findings and reflux monitoring results in candidates for bariatric surgery.

BACKGROUND: Gastroesophageal reflux disease (GERD) is common in patients with obesity. Diagnosing GERD is important as bariatric operations have different influence on GERD. We assessed reflux symptoms and objective findings prior to surgery. METHODS: Work-up included esophageal symptoms quantification by VAS-scores, esophagogastroduodenoscopy (EGD) and 24-h impedance-pH (imp-pH) monitoring off PPI therapy. Imp-pH was classified as abnormal if either %time pH<4 was abnormal, total number of reflux episodes was elevated or symptom index (SI) was positive. RESULTS: Among 100 consecutive patients (68F, age 40±11years, BMI 44.9±6.9kg/m2) 54% reported heartburn and/or regurgitation, 71% had objective evidence of GERD (38% endoscopic lesions and 33% only abnormal imp-pH results). Imp-pH was superior to EGD in identifying GERD (sensitivity 85% vs. 54%, p<0.01). Symptomatic and asymptomatic patients had similar prevalence of esophageal lesions (37% vs. 39%) and abnormal imp-pH findings (68% vs. 50%). Sixty nine percent of patients with abnormal %time pH<4 had a normal number of reflux episodes. CONCLUSION: Half of patients with obesity reported typical GERD symptoms and >70% had evidence of GERD. Poor acid clearance was the main mechanisms. Since typical reflux symptoms don't predict objective findings, endoscopy and reflux monitoring should be part of the surgery work-up especially before restrictive procedures.