Hiatal hernia recurrences after laparoscopic surgery: exploring the optimal technique.

INTRODUCTION: The recurrence rate of hiatal hernia (HH) after laparoscopic surgery with crural repair and Nissen or Toupet fundoplication is high (< 25-42%). HH repair can be reinforced with additional anterior sutures, vertical mesh strips (VMS) or mesh placement but the effect in the long-term (> 1 year) is still unclear. We determined the recurrence rate of HH after surgery and established whether the use of reinforcement techniques could reduce long-term recurrence rates. METHODS: In this retrospective cohort study patients were included if they underwent a laparoscopic fundoplication in this hospital between 2012 and 2019. HH was measured with computed tomography and baseline patient characteristics and surgical details were collected. Primary outcomes were recurrence of symptoms and re-intervention, secondary outcome was effect of surgical reinforcement techniques. Statistical analyses comprised chi-square tests, Mann-Whitney U tests and uni- and multivariable logistic regression analyses. RESULTS: In total, 307 patients were included, 206 women and 101 men. During primary surgery, 208 patients underwent a Toupet fundoplication and 97 patients underwent a Nissen fundoplication. Reinforcements consisted of anterior sutures in 132 patients, VMS in 89 patients and mesh in 17 patients. After primary surgery, recurrence of HH was diagnostically confirmed in 64 patients (20.8%). Use of VMS during primary surgery was significantly associated with fewer recurrences (OR = 0.34, p = 0.048), corrected for confounding factors. Secondary surgery was performed in 54 patients (17.6%) and tertiary surgery in five patients (1.6%). Mesh and VMS were used more during secondary and tertiary surgery. CONCLUSION: The recurrence rate among HH patients in this cohort study was 20.8% with a mean follow-up time of 6 years. Secondary surgery was performed in 17.6% of the patients. In future, the use of VMS might lead to fewer recurrences after primary laparoscopic repair of HH.

Evaluation of CPAP adherence in bariatric patients diagnosed with obstructive sleep apnea: outcomes of a multicenter cohort study.

PURPOSE: Obstructive sleep apnea (OSA) is highly prevalent but mostly undiagnosed in obese patients scheduled for bariatric surgery. To prevent cardiopulmonary complications, many clinics perform preoperative OSA screening. Consequently, adequate adherence to continuous positive airway pressure (CPAP) therapy is essential but challenging. We aimed to evaluate CPAP adherence and its influence on postoperative outcomes. METHODS: In a prospective multicenter cohort study, we compared different perioperative strategies for handling undiagnosed OSA in bariatric patients. In this subgroup analysis, patients newly diagnosed with OSA were compared to those with pre-existing OSA. We assessed inadequate CPAP adherence, defined as < 4 h/night, between the preoperative period and 6 months postoperative. Cardiopulmonary complications and (un)scheduled ICU admissions were also evaluated. RESULTS: In total, 272 patients with newly diagnosed OSA (67.4%) and 132 patients with pre-existing OSA (32.6%) were included. Before surgery, 41 newly diagnosed patients used CPAP inadequately, compared to 5 patients with pre-existing OSA (15% vs. 4%, p = 0.049). Six months after surgery, inadequate CPAP use increased to 73% for newly diagnosed patients and 39% for patients with pre-existing OSA, respectively (p < 0.001). Incidences of cardiopulmonary complications, scheduled, and unscheduled ICU admissions were similar in the two study groups (p = 0.600, p = 0.972, and p = 0.980, respectively). CONCLUSION: Inadequate CPAP adherence is higher in bariatric patients newly diagnosed with OSA when compared to patients with pre-existing OSA. Strategies to increase CPAP adherence may be valuable when considering routine OSA screening and CPAP therapy in patients undergoing bariatric surgery. Further studies are needed to improve current guidelines on perioperative OSA management of obese patients. TRIAL REGISTRATION: POPCORN study, registered at Netherlands Trial Register, https://www.trialregister.nl/trial/6805 . ID no: 6805.

META Score: An International Consensus Scoring System on Mesh-Tissue Adhesions.

BACKGROUND: Currently, the lack of consensus on postoperative mesh-tissue adhesion scoring leads to incomparable scientific results. The aim of this study was to develop an adhesion score recognized by experts in the field of hernia surgery. METHODS: Authors of three or more previously published articles on both mesh-tissue adhesion scores and postoperative adhesions were marked as experts. They were queried on seven items using a modified Delphi method. The items concerned the utility of adhesion scoring models, the appropriateness of macroscopic and microscopic variables, the range and use of composite scores or subscores, adhesion-related complications and follow-up length. This study comprised two questionnaire-based rounds and one consensus meeting. RESULTS: The first round was completed by 23 experts (82%), the second round by 18 experts (64%). Of those 18 experts, ten were able to participate in the final consensus meeting and all approved the final proposal. From a total of 158 items, consensus was reached on 90 items. The amount of mesh surface covered with adhesions, tenacity and thickness of adhesions and organ involvement was concluded to be a minimal set of variables to be communicated separately in each future study on mesh adhesions. CONCLUSION: The MEsh Tissue Adhesion scoring system is the first consensus-based scoring system with a wide backing of renowned experts and can be used to assess mesh-related adhesions. By including this minimal set of variables in future research interstudy comparability and objectivity can be increased and eventually linked to clinically relevant outcomes.

Metabolic improvement in obese patients after duodenal-jejunal exclusion is associated with intestinal microbiota composition changes.

BACKGROUND: Intestinal microbiota have been suggested to play an important role in the pathogenesis of obesity and type 2 diabetes. Bariatric surgery improves both conditions and has been associated with changes in intestinal microbiota composition. We investigated the effect of a nonsurgical bariatric technique on intestinal microbiota composition in relation to metabolic improvement. METHODS: Seventeen patients with obesity and type 2 diabetes were treated with the nonsurgical duodenal-jejunal bypass liner, which excludes the proximal 60 cm small intestine from food. Fecal samples as well as metabolic parameters reflecting obesity and type 2 diabetes were obtained from the patients at baseline, after 6 months with the device in situ, and 6 months after explantation. RESULTS: After 6 months of treatment, both obesity and type 2 diabetes had improved with a decrease in weight from 106.1 [99.4-123.5] to 97.4 [89.4-114.0] kg and a decrease in HbA1c from 8.5% [7.6-9.2] to 7.2% [6.3-8.1] (both p < 0.05). This was paralleled by an increased abundance of typical small intestinal bacteria such as Proteobacteria, Veillonella, and Lactobacillus spp. in feces. After removal of the duodenal-jejunal bypass liner, fecal microbiota composition was similar to that observed at baseline, despite persistent weight loss. CONCLUSION: Improvement of obesity and type 2 diabetes after exclusion of the proximal 60 cm small intestine by treatment with a nonsurgical duodenal-jejunal bypass liner may be promoted by changes in fecal microbiota composition.

Bariatric surgery in adolescents: a prospective randomized controlled trial comparing laparoscopic gastric banding to combined lifestyle interventions in adolescents with severe obesity (BASIC trial).

BACKGROUND: Obesity in children and adolescents is an increasing problem associated with multiple co-morbidities including metabolic and endocrine changes, cardiovascular abnormalities, and impaired quality of life. Combined lifestyle interventions are the current standard treatment for severe obesity in children. However, the medium- and long-term results of these interventions are relatively poor. Bariatric surgery shows substantial weight loss and health improvement in adults and retrospective studies in adolescents show similar outcomes. However, well-designed prospective studies in this young age group are rare. Our objectives are to determine whether combining surgery with lifestyle interventions in severely obese adolescents leads to a significant additional weight reduction compared to lifestyle interventions solely, and to assess its effect on obesity-associated co-morbidities in a prospective randomized controlled setting. METHODS: Patients aged 14-16 years with sex- and age-adjusted BMI > 40 kg/m2 (or > 35 kg/m2 with comorbidity) and failure to achieve weight reduction > 5% during at least one year of combined lifestyle interventions are included in this trial. Randomization determines whether laparoscopic adjustable gastric banding will be added to combined lifestyle intervention throughout the trial period. Sixty children will be included in this trial. Follow-up visits are planned at 6 months, 1,2 and 3 years. Primary endpoints are percentage of total weight loss, and change of BMI. Secondary endpoints include body composition, pubertal development, metabolic and endocrine changes, inflammatory status, cardiovascular abnormalities, non-alcoholic steatohepatitis, quality of life and changes in behaviour. DISCUSSION: This randomized controlled trial is designed to provide important information about the safety and efficacy of laparoscopic adjustable gastric banding treatment in severely obese adolescents with unsuccessful combined lifestyle interventions. The reversibility of this surgical procedure forms a strong argument to decide for gastric banding over other surgical procedures, since bariatric surgery in adolescents is still in its infancy. TRIAL REGISTRATION: The BASIC trial is registered in the register of ClinicalTrials.gov since July 2010, Identifier: NCT01172899.

[EndoBarrier as a treatment for obesity and diabetes]. / EndoBarrier als behandeling voor obesitas en diabetes.

The EndoBarrier (duodenal-jejunal bypass liner) became available in 2009 as an endoscopic treatment method for obesity and type 2 diabetes mellitus (T2D). The treatment results in significant weight loss and improvement of the obesity-related morbidities such as T2D, non-alcoholic steatohepatitis, hypertension and other cardiovascular diseases. However, unexpected complications such as liver abscesses can occur, in addition to expected adverse events such as bleeding, obstruction, and migration. The incidence of these complications is low however, and to date no treatment-related mortality has occurred with the use of EndoBarrier. After more than 3800 procedures, it can be concluded that the EndoBarrier is safe and effective. This treatment option can be applied in patients with a BMI over 30 kg/m2 and also obese patients with T2D who do not wish to undergo, or are not fit for, a surgical procedure.

TUB gene expression in hypothalamus and adipose tissue and its association with obesity in humans.

BACKGROUND/OBJECTIVES: Mutations in the Tubby gene (TUB) cause late-onset obesity and insulin resistance in mice and syndromic obesity in humans. Although TUB gene function has not yet been fully elucidated, studies in rodents indicate that TUB is involved in the hypothalamic pathways regulating food intake and adiposity. Aside from the function in central nervous system, TUB has also been implicated in energy metabolism in adipose tissue in rodents. We aimed to determine the expression and distribution patterns of TUB in man as well as its potential association with obesity. SUBJECTS/METHODS: In situ hybridization was used to localize the hypothalamic regions and cells expressing TUB mRNA. Using RT-PCR, we determined the mRNA expression level of the two TUB gene alternative splicing isoforms, the short and the long transcript variants, in the hypothalami of 12 obese and 12 normal-weight subjects, and in biopsies from visceral (VAT) and subcutaneous (SAT) adipose tissues from 53 severely obese and 24 non-obese control subjects, and correlated TUB expression with parameters of obesity and metabolic health. RESULTS: Expression of both TUB transcripts was detected in the hypothalamus, whereas only the short TUB isoform was found in both VAT and SAT. TUB mRNA was detected in several hypothalamic regions involved in body weight regulation, including the nucleus basalis of Meynert and the paraventricular, supraoptic and tuberomammillary nuclei. We found no difference in the hypothalamic TUB expression between obese and control groups, whereas the level of TUB mRNA was significantly lower in adipose tissue of obese subjects as compared to controls. Also, TUB expression was negatively correlated with indices of body weight and obesity in a fat-depot-specific manner. CONCLUSIONS: Our results indicate high expression of TUB in the hypothalamus, especially in areas involved in body weight regulation, and the correlation between TUB expression in adipose tissue and obesity. These findings suggest a role for TUB in human obesity.

MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy.

BACKGROUND: Pose SM is an endolumenal weight-loss intervention in which suture anchors are placed endoscopically in the gastric fundus/distal gastric body. Observational studies of pose have shown safe, effective weight loss. Twelve-month results of a randomized controlled trial comparing weight loss and satiety after pose vs. conventional medical therapy are reported. METHODS: Subjects with classes I-II obesity were randomized in a 3:1 ratio to pose or diet/exercise guidance only (control). Pose subjects received gastric fundus and distal body suture-anchor plications with diet/exercise counseling. Total body (%TBWL) and excess weight loss (%EWL) were assessed at 6 and 12 months. Analysis of covariance (ANCOVA) was used to analyze 12-month %TBWL. Satiety changes were assessed at 6 and 12 months. RESULTS: From November 2013 to July 2014, 44 subjects were randomized (34, 77.3 % female; mean age, 38.3 ± 10.7 years; body mass index, 36.5 ± 3.4 kg/m2) to pose (n = 34) or control (n = 10) groups in three centers. Mean pose procedure time was 51.8 ± 14.5 min; pose subjects received a mean 8.8 ± 1.3 fundal and 4.2 ± 0.7 distal body plications. Twelve-month TBWL: pose, 13.0 % (EWL, 45.0 %), n = 30 vs. control group, 5.3 % (18.1 %), n = 9; significant mean difference, 7.7 % (95 % CI 2.2, 13.2; p < 0.01). Pose subjects showed significant reductions in satiety parameters (p < 0.001); controls experienced reduced caloric intake and satiety volume (p < 0.05). No serious device- or procedure-related adverse events occurred. CONCLUSIONS: In a randomized controlled trial at 12 months, pose-treated subjects had significantly greater weight loss than those treated with diet/exercise guidance alone. At 6 and 12 months, pose subjects showed significant reduction in satiety parameters. STUDY REGISTRATION: clinicaltrials.gov identifier # NCT01843231.

Determining the association between adipokine expression in multiple tissues and phenotypic features of non-alcoholic fatty liver disease in obesity.

OBJECTIVES: Non-alcoholic fatty liver disease (NAFLD) is an obesity-associated disease, and in obesity adipokines are believed to be involved in the development of NAFLD. However, it is still not clear whether adipokines in the liver and/or adipose tissues can be related to the development of specific characteristics of NAFLD, such as steatosis and inflammation. We aimed to address this question by simultaneously examining the adipokine expression in three tissue types in obese individuals. METHODS: We enrolled 93 severely obese individuals with NAFLD, varying from simple steatosis to severe non-alcoholic steatohepatitis. Their expression of 48 adipokines in the liver, visceral and subcutaneous adipose tissue (SAT) was correlated to their phenotypic features of NAFLD. We further determined whether the correlations were tissue specific and/or independent of covariates, including age, sex, obesity, insulin resistance and type 2 diabetes (T2D). RESULTS: The expression of adipokines showed a liver- and adipose tissue-specific pattern. We identified that the expression of leptin, angiopoietin 2 (ANGPT2) and chemerin in visceral adipose tissue (VAT) was associated with different NAFLD features, including steatosis, ballooning, portal and lobular inflammation. In addition, the expression of tumor necrosis factor (TNF), plasminogen activator inhibitor type 1 (PAI-1), insulin-like growth factor 1 (somatomedin C) (IGF1) and chemokine (C-X-C motif) ligand 10 (CXCL10) in the liver tissue and the expression of interleukin 1 receptor antagonist (IL1RN) in both the liver and SAT were associated with NAFLD features. The correlations between ANGPT2 and CXCL10, and NAFLD features were dependent on insulin resistance and T2D, but for the other genes the correlation with at least one NAFLD feature remained significant after correcting for the covariates. CONCLUSIONS: Our results suggest that in obese individuals, VAT-derived leptin and chemerin, and hepatic expression of TNF, IGF1, IL1RN and PAI-1 are involved in the development of NAFLD features. Further, functional studies are warranted to establish a causal relationship.

Adhesions to sutures, tackers, and glue for intraperitoneal mesh fixation: an experimental study.

PURPOSE: Intraperitoneal mesh fixation for hernia repair is associated with adhesion formation. In this experimental study, adhesions against absorbable and non-absorbable fixation methods were compared. METHODS: Six commercially available fixation methods were placed intraperitoneally in rats with a small pore polypropylene mesh coated on one side with ePTFE (Intramesh T1(®)). Two non-absorbable fixation methods: Prolene(®) (polypropylene) sutures and Protack(®) (titanium) tackers. Four absorbable methods: Vicryl(®) sutures (polyglactin), Absorbatack(®) and Permasorb(®) tackers (both mixes of lactic and glycolic acids) and Tisseel Duo(®) (fibrin glue). Adhesions and histology were studied at 7 and 90 days follow-up. In addition, fixation methods were placed without mesh, in order to study the reaction to the fixation method per se. RESULTS: No adhesion formation, but also inadequate mesh fixation was found with Tisseel Duo(®), which had been completely resorbed at 7 days follow-up. Vicryl(®) sutures could no longer be detected at 90 days follow-up and were associated with a favorable adhesion profile. All other fixation methods were still intact 90 days after implantation. When placed without mesh, adhesion formation was significantly less than placed with a mesh (18 vs. 93 %, P < 0.001). Without mesh, adhesions were worst with Permasorb(®) tackers. CONCLUSIONS: Absorbable fixation methods such as polyglactin sutures and fibrin glue show a favorable adhesion profile compared to longer-term absorbable or non-absorbable fixation methods. However, before using fibrin glue as a single fixation method more research is required.

Revision of laparoscopic adjustable gastric banding: success or failure?

BACKGROUND: Laparoscopic adjustable gastric banding (LAGB) is a safe and frequently performed bariatric procedure. Unfortunately, re-operations are often necessary. Reports on the success of revisional procedures are scarce and show variable results, either supporting or declining the idea of revising LAGB. This study describes a large cohort of re-operations after failed LAGB to determine the success of revision. METHODS: By use of a prospective cohort, all LAGB revisions performed between 1996 and 2008 were identified. From 301 primary LAGB procedures in our centre, 43 patients (14.3%) required a band revision. In addition, 51 patients were referred from other centres. Our analysis included in total 94 patients with a mean follow-up period of 38 months after revision. RESULTS: Revision was mainly necessary due to anterior slippage (46%) and symmetrical pouch dilatation (36%), which could be resolved by replacing (70%) or refixating the band (27%). Weight loss significantly increased after revision (excess BMI loss (EBMIL), 37.2 ± 36.3% versus 47.5 ± 30.4%, P < 0.05). After revision, 23 patients (24%) needed a second re-operation. Patients converted to other procedures (16%) during the second re-operation showed larger weight loss than the revised group (EBMIL, 64.3 ± 28.1% versus 44.3 ± 28.7%, P < 0.05). CONCLUSIONS: We report on a large cohort of LAGB revisions with 38 months of follow-up. Revision of failed LAGB by either refixation or replacement of the band is successful and further increases weight loss.

Degradation of mesh coatings and intraperitoneal adhesion formation in an experimental model.

BACKGROUND: In laparoscopic ventral hernia repair a mesh is placed in direct contact with the viscera, often leading to substantial adhesions. In this experimental study the ability of different coated and uncoated meshes to attenuate adhesion formation was examined. METHODS: Six commercially available meshes were placed intraperitoneally against a closed peritoneum in rats: Prolene (polypropylene), Timesh and Ultrapro (polypropylene composites with titanium and polyglecaprone respectively), Proceed and Parietex Composite (polypropylene and polyester meshes coated with a layer of cellulose and collagen respectively) and C-Qur (polypropylene mesh coated with a layer of omega-3 fatty acids). Adhesions and incorporation were evaluated macroscopically and microscopically after 7 and 30 days. RESULTS: Parietex Composite and C-Qur significantly reduced adhesion formation at 7 days' follow-up compared with all other meshes. By 30 days, this effect had diminished as a significant increase in adhesions together with phagocytosis of the coating was seen for all meshes with layered coatings (Proceed, Parietex Composite and C-Qur. Incorporation was insufficient for all meshes. CONCLUSION: The absorbable layers of Parietex Composite and C-Qur reduce adhesion formation to intraperitoneal mesh in the short term, but the effect diminishes and phagocytosis of absorbable coatings may contribute to adhesion formation.

[Gastric reduction in morbidly obese adults in the Netherlands]. / Maagverkleining bij volwassenen met morbide obesitas in Nederland.

Obesity results in several health problems, the most important of these being diabetes mellitus type 2. In patients with morbid obesity (BMI > or = 35 kg/m(2) and comorbidity or BMI > or = 40 kg/m(2)) in particular, prevention or treatment of health problems resulting from the obesity is only possible with considerable and lasting weight loss. Gastric reduction surgery with the adjustable gastric band has been shown to be safe and effective. This is also true for the more invasive techniques such as the gastric bypass and the biliopancreatic diversion. Surgical treatment is the only treatment that can induce substantial and lasting weight loss (> 50% of the excess weight, on average) in this patient group in the long run. Although the availability of surgical treatment is as yet inadequate in the Netherlands, it has recently improved considerably. Reimbursement of the treatment is however still an obscure issue and the reimbursement of the follow-up is uncertain. Possibly, the current experiments with independent treatment centers will be able to put an end to this uncertainty.

Face validation of the Simbionix LAP Mentor virtual reality training module and its applicability in the surgical curriculum.

BACKGROUND: The goal of our study was to determine expert and referent face validity of the LAP Mentor, the first procedural virtual reality (VR) laparoscopy trainer. METHODS: In The Netherlands 49 surgeons and surgical trainees were given a hands-on introduction to the Simbionix LAP Mentor training module. Subsequently, a standardized five-point Likert-scale questionnaire was administered. Respondents who had performed over 50 laparoscopic procedures were classified as "experts." The others constituted the "referent" group, representing nonexperts such as surgical trainees. RESULTS: Of the experts, 90.5% (n = 21) judge themselves to be average or above-average laparoscopic surgeons, while 88.5% of referents (n = 28) feel themselves to be less-than-average laparoscopic surgeons (p = 0.000). There is agreement between both groups on all items concerning the simulator's performance and application. Respondents feel strongly about the necessity for training on basic skills before operating on patients and unanimously agree on the importance of procedural training. A large number (87.8%) of respondents expect the LAP Mentor to enhance a trainee's laparoscopic capability, 83.7% expect a shorter laparoscopic learning curve, and 67.3% even predict reduced complication rates in laparoscopic cholecystectomies among novice surgeons. The preferred stage for implementing the VR training module is during the surgeon's residency, and 59.2% of respondents feel the surgical curriculum is incomplete without VR training. CONCLUSION: Both potential surgical trainees and trainers stress the need for VR training in the surgical curriculum. Both groups believe the LAP Mentor to be a realistic VR module, with a powerful potential for training and monitoring basic laparoscopic skills as well as full laparoscopic procedures. Simulator training is perceived to be both informative and entertaining, and enthusiasm among future trainers and trainees is to be expected. Further validation of the system is required to determine whether the performance results agree with these favorable expectations.

Evidence-base guideline on management of colorectal liver metastases in the Netherlands.

A dutch national evidence-based guideline on the diagnosis and treatment of patients with colorectal liver metastases has been developed. The most important recommendations are as follows. For synchronous liver metastases, spiral computed tomography (CT) or magnetic resonance imaging (MRI) should be used as imaging. For evaluation of lung metastases, imaging can be limited to chest radiography. For detection of metachronous liver metastases, ultrasonography could be performed as initial modality if the entire liver is adequately visualised. In doubtful cases or potential candidates for surgery, CT or MRI should be performed as additional imaging. For evaluation of extrahepatic disease, abdominal and chest CT could be performed. Fluorodeoxyglucose positron emission tomography could be valuable in patients selected for surgery based on CT (liver/abdomen/chest), for identifying additional extrahepatic disease. Surgical resection is the treatment of choice with a five-year survival of 30 to 40%. Variation in selection criteria for surgery is caused by inconclusive data in the literature concerning surgical margins.