Swallowable intragastric balloons represent an evolving minimally invasive treatment option for obesity. The current first-in-human study evaluated the safety and efficiency of a novel swallowable self-expanding intragastric balloon (IGBalloon©) with a kidney-shaped design, intended to reduce the risk of migration. Single-center, prospective first-in-human study at a tertiary metabolic/bariatric center. This prospective open-label, non-randomized trial was designed to include 20 patients with obesity. Patients with a body mass index (BMI) >35 kg/m² or >30 kg/m² with at least one obesity-related complication were eligible. The primary endpoints were safety and efficacy, including weight loss and remission of obesity-related complications. Patients were allowed to ingest up to five balloons during follow-up. Due to two severe adverse events (SAE), the trial was terminated prematurely after the inclusion of five patients. Two patients developed small bowel obstruction caused by balloon migration through the pylorus, requiring emergency laparoscopic enterotomy and balloon removal. This first-in-human study demonstrated a substantial risk of balloon migration and small bowel obstruction associated with the current kidney-shaped IGBalloon© design. The device in its present form is not qualified for clinical use.
BACKGROUND:Metabolic and bariatric surgery (MBS) is associated with sustained weight loss and metabolic improvement. However, the understanding of its long-term effects on skeletal health remains incomplete, particularly with respect to different surgical procedures. OBJECTIVES:This study aimed to evaluate long-term changes in bone metabolism, bone mineral density (BMD), and fracture risk after sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one-anastomosis gastric bypass (OAGB). SETTING:University hospital. METHODS:In this retrospective cohort with prospective long-term follow-up, 60 patients (20 RYGB, 20 OAGB, and 20 SG) underwent primary MBS. Dual-energy X-ray absorptiometry-derived bone densitometry and bone metabolism markers were assessed preoperatively and after a mean follow-up of 10.1± 2.5 years. Measurements included BMD, T-score, and z score at lumbar spine and femoral neck. Ten-year fracture probability was estimated using the FRAX (Fracture Risk Assessment tool) score. RESULTS:Bone metabolism markers largely remained within reference ranges throughout follow-up. Serum vitamin D levels increased significantly after all procedures reflecting postoperative supplementation. In contrast, significant reductions in femoral BMD was observed after all three procedures (SG: .99 ± .14 to .49 ± .17 g/cm2, P = .03; RYGB: 1.09 ± .80 to .59 ± .17 g/cm2, P = .02; OAGB: 1.11 ± .18 to .53 ± .13 g/cm2, P = .01), whereas lumbar spine BMD showed no significant change. FRAX-estimated 10-year risk for major osteoporosis and hip fractures was elevated at long-term follow-up. CONCLUSIONS:Despite largely preserved biochemical bone markers, substantial long-term structural bone loss and increased fracture risk were observed after MBS. These findings support the consideration of routine postoperative bone health surveillance following MBS to allow early therapeutic intervention when indicated.
Overweight and obesity have been steadily increasing worldwide. Metabolic/bariatric surgery (MBS) is the most effective treatment for obesity and its associated medical conditions. Obesity complications increase with age, however, older patients face a higher perioperative risk necessitating a clear risk-benefit balance. This study evaluated weight-loss outcomes, remission of associated medical conditions, and complications in patients aged ≥ 65 years undergoing MBS. This retrospective analysis included patients aged ≥ 65 years who underwent MBS at the Medical University of Vienna between 2008 and 2025. Weight and associated medical complications were assessed at baseline and at 1, 2, and 5 years postoperatively. Early (< 30 days) and late complications up to 5 years were recorded. In total, 111 patients were included. Baseline weight was 125.8 ± 22.3 kg and BMI 45.2 ± 7.4 kg/ m^2 . At 5 years, mean BMI decreased to 27.5 ± 6.2 kg/ m^2 corresponding to a total weight loss of 37.3 ± 14.7
Endoluminal vacuum therapy (EVT, Eso-SPONGE®) is an effective treatment for leaks following metabolic-bariatric surgery (MBS), used for staple line- or anastomotic leakage. While EVT is conventionally placed using an overtube, the pull-through technique is a convenient alternative for hardly accessible dehiscence or large wound cavity, allowing precise sponge placement for optimal drainage. This analysis provides a technical note and evaluates pull-through EVT’s efficacy in MBS patients. All patients treated for leaks after MBS with EVT pull-through technique between 01/2018 and 06/2025 at the Department of General Surgery, Medical University of Vienna (MUV), were included in this retrospective analysis. Statistical analyses were performed descriptively. 7 patients were treated with EVT via pull-through technique. In 5/7 cases (71.4
One-anastomosis gastric bypass (OAGB) is the third most common metabolic/bariatric procedure worldwide. A point for discussion regarding OAGB is acid and non-acid reflux in mid- and long-term follow-up. The aim of this study was to objectively evaluate reflux and esophagus motility by comparing pre- and postoperative results of 24-h pH-metry, high-resolution manometry (HRM), and gastroscopy. Cross-sectional study and university hospital based. This study includes primary OAGB patients operated at the Medical University of Vienna before 31st December 2022. After a mean follow-up of 4.1 ± 2.9 years, the preoperative examinations were repeated. Additionally, history of weight, remission of obesity-related complications (ORC), and quality of life (QOL) were evaluated. A total of 50 patients were included in this study and went through all examinations. Preoperative weight was 125.5 ± 21.0 kg with a BMI of 44.6 ± 5.4 kg/m2 and total weight loss after 4.1 ± 2.9 years was 37.1 ± 8.1
Metabolic/bariatric surgery (MBS) remains the most effective and long-lasting treatment for obesity and its complications. Apart from any surgical complications, the often less obvious but possibly severe side-effects of nutritional deficiencies have become of interest in recent years. OAGB is known to come with the need for thorough supplementation. Retrospective study; university-hospital based. Assessing nutritional issues and their management in a real-life cohort of patients undergoing OAGB. Patients that underwent OABG between 01/2018 and 08/2019 were retrospectively assessed. Laboratory values (gained from electronic patients charts) were analyzed for nutritional issues (parathyroid hormone, vitamin A, E, D, B12, folic acid, albumin, ferritin, iron, and transferrin saturation) as well as postoperative complications and reoperations. Furthermore, weight development, improvement/remission of obesity-related complications, and regular intake of multivitamin supplementation (MVS) were assessed. 120 patients underwent OAGB; 89 were female. A follow-up was available for 101 patients. Mean length of follow-up was 27.8 ± 20.9 months. OAGB led to a
Metabolic dysfunction-associated steatotic liver disease (MASLD) and related steatohepatitis (MASH) are common among obese patients and may improve after metabolic/bariatric surgery (MBS). 93 Patients undergoing MBS in 2021–2022 were prospectively enrolled. Liver stiffness measurement (LSM; via vibration-controlled transient elastography [VCTE], point [pSWE] and 2D [2DSWE] shear wave elastography) and non-invasive steatosis assessment (via controlled attenuation parameter [CAP]) were performed before (baseline [BL]) and three months (M3) after surgery. 93 patients (median age 40.9 years, 68.8% female, median BL-BMI: 46.0 kg/m2) were included. BL-liver biopsy showed MASLD in 82.8% and MASH in 34.4% of patients. At M3 the median relative total weight loss (%TWL) was 20.1% and the median BMI was 36.1 kg/m2. LSM assessed by VCTE and 2DSWE, as well as median CAP all decreased significantly from BL to M3 both in the overall cohort and among patients with MASH. There was a decrease from BL to M3 in median levels of ALT (34.0 U/L to 31 U/L; p = 0.025), gamma glutamyl transferase (BL: 30.0 to 21.0 U/L; p < 0.001) and MASLD fibrosis score (BL: − 0.97 to − 1.74; p < 0.001). Decreasing LSM and CAP, as well as liver injury markers suggest an improvement of MASLD/MASH as early as 3 months after MBS.
BackgroundMetabolic bariatric surgery (MBS) is standardized and safe. Nevertheless, complications such as anastomotic leakage (AL) or staple-line leakage (SLL) can occur. In upper GI or colorectal surgery, endoluminal vacuum therapy (EVT) offers a therapeutic alternative to revisional surgery. Data on EVT in patients with leakage after MBS remain scarce. The aim of this study is to evaluate the efficacy of EVT and its potential as endoscopic alternative to revisional surgery.Material and MethodsAll patients treated for AL or SLL with EVT after MBS between 01/2016 and 08/2023 at the Department for General Surgery, Medical University Vienna, were included in this retrospective, single-center study. Therapeutic value of EVT as management option for acute postoperative leakage after MBS in daily practice was evaluated. Statistical analyses were performed descriptively.ResultsTwenty-one patients were treated with EVT within the observational period of 7 years. In 11 cases (52.4%), the index surgery was a primary bariatric intervention; in 10 cases (47.6%), a secondary surgery after initial MBS was performed. Favored approach was a combination of revisional surgery and EVT (n = 18; 85.7%), intermediate self-expanding metal stent (SEMS) in 16 (76.2%) cases. EVT was changed six times (0-33) every 3-4 days. Mean EVT time was 25.1 days (3-97). No severe associated complications were detected and EVT showed an efficacy of 95.2%.ConclusionThis small case series supports the trend to establish EVT in daily clinical practice when revisional surgery after MBS is needed, thus preventing further reoperation and reducing associated morbidity and mortality in critically ill patients.
Obesity causes genetic instability, which plays a key-role in the etiology of cancer and aging. We investigated the impact of bariatric surgery (BS) on DNA repair, oxidative DNA damage, telomere lengths, alterations of antioxidant enzymes and, selected proteins which reflect inflammation. The study was realized with BS patients (n = 35). DNA damage, base oxidation, BER, and NER were measured before and 1 month and 6 months after surgery with the single-cell gel electrophoresis technique. SOD and GPx were quantified spectrophotometrically, malondealdehyde (MDA) was quantified by HPLC. Telomere lengths were determined with qPCR, and plasma proteome profiling was performed with high-resolution mass spectrophotometry. Six months after the operations, reduction of body weight by 27.5% was observed. DNA damage decreased after this period, this effect was paralleled by reduced formation of oxidized DNA bases, a decline in the MDA levels and of BER and NER, and an increase in the telomere lengths. The activities of antioxidant enzymes were not altered. Clear downregulation of certain proteins (CRP, SAA1) which reflect inflammation and cancer risks was observed. Our findings show that BS causes reduced oxidative damage of DNA bases, possibly as a consequence of reduction of inflammation and lipid peroxidation, and indicate that the surgery has beneficial long-term health effects.
Laparoscopic Roux-en-Y Gastric Bypass (RYGB) is a commonly used method in bariatric surgery that leads to sufficient long-term weight loss and consequently to improvement or resolution of obesity-associated diseases. The nadir weight is commonly reached between six months and two years after surgery. Despite this initially good weight loss, weight regain is observed in up to 20% of the patients. Besides intensive dietological evaluation, bariatric re-operation can be an option in these cases. Before the surgical reintervention, an intensive evaluation of the esophagus, pouch, anastomosis, and adjacent small bowel using upper GI-endoscopy and radiological examinations (X-ray and/or 3D-CT volumetry) is mandatory. In patients with a dilated pouch, pouch-resizing with a MiniMIZER® Gastric Ring (Bariatric Solutions GmbH, Stein am Rhein, Switzerland) could be an option to reestablish restriction in the long term. Currently, there is no gold standard for the choice of the weight regain procedure or for the technique used in the procedure itself. This article focuses on the standardized procedure of pouch resizing with implantation of a MiniMIZER® Gastric Ring for the surgical therapy of weight regain due to pouch dilatation and/or dilatation of the gastrojejunostomy and the adjacent small bowel (usually approximately the first 20cm), resulting in a huge neo-stomach after RYGB, as performed at the Medical University of Vienna. Further, indications for revisional surgery for weight regain, mandatory examinations, and recommended conservative therapy options prior to surgery will be described. Next, the fast-track concept and its advantages are explained. Lastly, the surgical procedure, including positioning of the patient, placement of trocars, the intraoperative process, and special advice, is presented. Exact planning of the procedure and postoperative follow-up are indispensable for a further long-term success after weight regain surgery. In conclusion, pouch-resizing and implantation of the MiniMIZER® Gastric Ring represent a practical and effective solution in patients with dilated pouch/anastomosis/adjacent small bowel with weight regain after RYGB, if conservative therapy, including dietitian counseling and new drugs (e.g., Semaglutide), has failed.
Laparoscopic Single Anastomosis Duodeno-Ileal Bypass with Sleeve Gastrectomy (SADI-S) is a bariatric/metabolic procedure that has been gaining popularity in recent years. SADI-S strongly affects the secretion of various gut hormones, adipocytokines and incretins. From a mechanistic point of view, the operation combines malabsorption and restriction, and has been shown to have a long-lasting and significant impact on weight loss and remission of comorbidities. With regard to the technique, first, a Sleeve is created and then the duodenum is tran-sected approximately 3-4cm after the pylorus at the level of the gastroduodenal artery (GDA). Next, 250-300cm of small bowel is measured from the caecum and a hand-sewn duo-deno-ileal anastomosis is performed. The length of the biliopancreatic limb is variable in this procedure. Because of the standardized common limb length in all patients, weight loss is very precise within a low range. Nevertheless, due to the complex hand-sewn anastomosis and the delicacy necessary when handling the duodenum, this procedure should be reserved for experienced bariatric surgeons in specialized centers. This article provides an overview of the standard surgical technique at the Department of Visceral Surgery at the Medical University of Vienna, as well as information about patient selection and pre- and postoperative care.
Sleeve gastrectomy (SG) is the commonest bariatric procedure worldwide but there is also a high conversion rate mainly due to weight regain and gastroesophageal reflux disease (GERD) reported in studies with long-term follow-up. The aim of this study is to highlight benefits and limitations of converting SG patients to Roux-en-Y gastric bypass (RYGB) and one-anastomosis gastric bypass (OAGB). Retrospective cross-sectional-study, medical university clinic setting. This study includes all patients converted from primary SG to RYGB or OAGB by 12/2018 at the Medical University of Vienna. Patients were examined using gastroscopy, esophageal manometry, 24-h pH-metry, and questionnaires. Fifty-eight patients were converted from SG to RYGB (n = 45) or OAGB (n = 13). Total weight loss of patients converted to RYGB and OAGB was 41.5% and 44.8%, respectively, at nadir. Six patients had Barrett’s esophagus (BE) after SG. In four out of these six patients, a complete remission of BE after conversion to RYGB was observed; nevertheless, two patients after RYGB and one after OABG newly developed BE. Clinical GERD improved at a higher rate after RYGB than after OAGB. Both revisional procedures improved associated medical problems. Conversion to RYGB is probably the best option for patients with GERD after SG. OAGB has shown a low potential to cure patients from GERD symptoms after SG. In terms of additional weight loss and remission of associated medical problems, both procedures studied were equal. Surveillance gastroscopies every 5 years after SG revisions are recommended.
Purpose Papillary thyroid carcinoma (PTC) spreads early to lymph nodes (LN). However, prophylactic central (CND) and lateral neck dissection (LND) is controversially discussed in patients with clinically negative nodes (cN0). The preoperative prediction of LN metastasis is desirable as re-operation is associated with higher morbidity and poor prognosis. The study aims to analyse possible benefits of a systemic bilateral diagnostic lateral lymphadenectomy (DLL) for intraoperative LN staging. Methods Preoperative prediction of LN metastasis by conventional ultrasound (US) was correlated with the results of DLL and intra-/postoperative complications in 118 consecutive patients with PTC (cN0) undergoing initial thyroidectomy and bilateral CND and DLL. Results Lateral LNs (pN1b) were positive in 43/118 (36.4%) patients, including skip lesions ( n = 6; 14.0%). Preoperative US and intraoperative DLL suspected lateral LN metastasis in 19/236 (TP: 8.1%) and 54/236 (TP: 22.9%) sides at risk, which were confirmed by histology. Sixty-seven out of 236 (FN: 28.4%) and 32/236 (FN: 13.6%) sides at risk with negative preoperative US and intraoperative DLL lateral LN metastasis were documented. DLL was significantly superior compared to US regarding sensitivity (62.8% vs 22.1%; p < 0.002), positive predictive value (100% vs 76.0%), negative predictive value (82.4% vs 68.2%), and accuracy (86.4% vs 69.1%), but not specificity (100% vs 96.0%; p = 0.039). DLL-related complications (haematoma) occurred in 6/236 [2.5%] sides at risk, including chylous fistula in 2/118 [1.7%] patients. Conclusion DLL can be recommended for LN staging during initial surgery in patients with PTC to detect occult lateral LN metastasis not suspected by US in order to plan lateral LN dissection.
Glucocorticoids have three distinct therapeutically relevant effects (genomic, specific non-genomic, and unspecific non-genomic), raising the hypothesis that the relative potencies of non-genomic and genomic effects of glucocorticoids may differ. Therefore, we measured the unspecific non-genomic potencies of five clinically important glucocorticoids and compared them with the classical (genomic) potencies. We studied the immediate glucocorticoid effects on respiration, on protein synthesis, and on Na+-K+-ATPase and Ca2+-ATPase in concanavalin A-stimulated rat thymocytes. We titrated the respiration of the cells with methylprednisolone, prednylidene, dexamethasone, prednisolone or betamethasone, and then interpolated the glucocorticoid concentrations needed to inhibit concanavalin A-stimulated respiration back to normal. These "equivalent doses" produced equal inhibition of respiration, of specific energy-consuming pathways, and of the concanavalin A effect on quiescent cells. The relative drug potencies were calculated as the inverse of the equivalent doses normalized to methylprednisolone and were: prednylidene (3.0) > dexamethasone (1.2) > methylprednisolone (1.0) > prednisolone (0.4) > betamethasone (0.2). This hierarchy is completely different from that for the classical effects. These new data are of crucial relevance for in vitro experiments and clinical use, especially in glucocorticoid high-dose therapy. Examples are the choice between methylprednisolone and prednisolone in pulse therapy, and the completely different clinical usage of dexamethasone and betamethasone, despite their similar affinities for nuclear receptors.
BACKGROUND:Male obesity secondary hypogonadism (MOSH) is a common disease among men with obesity and can be associated with metabolic syndrome and a variety of metabolic problems ultimately leading to androgen deficiency. Metabolic and bariatric surgery is a well-established treatment option associated with significant weight loss and reduction in metabolic co-morbidities. OBJECTIVES:To evaluate the impact of surgery on plasma levels of sexual hormones and their effect on weight loss comparing 2 surgical methods (one-anastomosis gastric bypass [OAGB] and Roux-en-Y gastric bypass [RYGB]) in male patients with obesity. SETTING:University hospital, Austria. METHODS:Patients undergoing OAGB and RYGB between 2012 and 2017 were analyzed retrospectively. Follow-up in this study was up to 24 months. Systemic levels of sexual hormones (luteinizing hormone [LH]), follicle stimulating hormone [FSH], total testosterone [TT], sexual hormone binding globin [SHBG], 17 beta-estradiol [17bE], androstenedione [AS]) were retrieved at each visit. A linear mixed model was used to assess the correlation between changes in testosterone levels and percent excess weight loss (%EWL). RESULTS:In 30.8% of all patients, MOSH was present preoperatively. A significant increase of TT was observed postoperatively that led to a complete resolution of hypogonadism within the period observed. Bioavailable testosterone (bTT) and FSH levels significantly increased each month of follow-up after surgery (all P < .01). Levels of 17bE did not change significantly after surgery. The overall change of TT, comparing preoperative and 1-year postoperative TT levels (ΔTT), significantly correlated with %EWL. Changes in TT levels were not affected by the choice of surgical method. CONCLUSIONS:Serum plasma testosterone levels rise significantly after metabolic and bariatric surgery in male patients. The change of testosterone levels seems to play a role in continued weight loss after surgery. This is true irrespective of the surgical method used.
INTRODUCTION:Sleeve gastrectomy (SG) is the most common bariatric operation with over 340,000 procedures per year. There are only few studies presenting follow-up results >10 years in the literature today. The aim of this study was the objective evaluation of long-term outcomes of at least 15 years after SG in non-converted patients. METHODS:This study (multicenter cross-sectional; university-hospital based) includes all non-converted patients with primary SG before December 2005 at participating bariatric centers. The following methods were used: gastroscopy, esophageal manometry, 24-h pH-metry, and Gastrointestinal Quality of Life Index (GIQLI). RESULTS:After removing converted patients, patients with bariatric procedures before SG, and deceased patients from the cohort, 20 of 53 participants have met the inclusion criteria. Of this group, 55% are suffering from symptomatic gastroesophageal reflux disease (GERD); 45% are without GERD. Esophagitis, hiatal hernias, Barrett's esophagus, and enlarged sleeves were found in 44%, 50%, 13%, and 69% of patients during gastroscopy. Mean lower esophageal sphincter pressure was normal at 20.2 ± 14.1 mm Hg during manometry. Reflux activity in 24 h, number of refluxes, and DeMeester score were increased at 12.9 ± 9.7%, 98.0 ± 80.8, and 55.3 ± 36.3 during 24-h pH-metry. Patients with GERD scored significantly lower in the GIQLI than patients without GERD: 107.6 ± 18.4 versus 127.6 ± 14.4 (p = 0.04). DISCUSSION/CONCLUSION:Fifteen years after primary SG, objective testing has shown that GERD, esophagitis, and Barrett's esophagus are major issues for these patients. Surveillance endoscopies at 5-year intervals in all SG patients and 3-year intervals in patients with Barrett's esophagus are recommended.
Background: One-anastomosis gastric bypass (OAGB) is a well-established treatment method in patients with morbid obesity. Its long-term impact on de novo reflux, anastomotic complications, and malnutrition needs further evaluation. Roux-en-Y gastric bypass (RYGB) is a technically feasible procedure in revisional bariatric surgery. This study presents our institutional data on conversion from OAGB to RYGB. Objective: To determine the reasons for conversion, preoperative endoscopic findings, and feasibility of revisional bariatric surgery after OAGB. Setting: University hospital in Austria Methods: Retrospective analysis of a prospectively fed database. All patients undergoing OAGB between January 2012 and December 2019 were included. Screening was carried out for all patients needing conversion to RYGB. Percent total weight loss, percent excess weight loss, time to conversion, postoperative complications, and reasons for conversion were assessed. Results: Eighty-two of 1,025 patients who underwent OAGB were converted laparoscopically to RYGB. Seven patients were converted early because of anastomotic/gastric tube leakage. Median time to late conversion was 29.1 +/- 24.3 months, mean percent excess weight loss was 86.6% +/- 33.1% and percent total weight loss was 35.1% +/- 13.5%. Forty-two patients were converted because of reflux, 11 because of persistent marginal ulcers, 10 because of anastomotic stenosis, 9 because of malnutrition, and 3 because of weight regain. Seven patients showed Barrett's metaplasia in biopsies at the gastroesophageal junction before conversion. Conclusion: Laparoscopic conversion from OAGB to RYGB is technically feasible with a moderate rate of postoperative complications. Severe (bile) reflux is a serious long-term complication after OAGB, with 4.1% of patients needing conversion to RYGB. Endoscopy after OAGB in patients showing clinical symptoms of gastroesophageal reflux disease is strongly advised to detect underlying pathologic changes. (C) 2021 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.