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BACKGROUND: The sleeve gastrectomy (SG) has become the most common bariatric procedure worldwide. However, insufficient weight loss or weight recidivism is frequent, which may require effective and safe revisional procedures. OBJECTIVE: To determine the technical feasibility and safety of a minimally invasive, duodeno-ileal side-to-side anastomosis using a Sutureless Neodymium Anastomosis Procedure (SNAP) for patients with weight recidivism or inadequate weight loss following SG. METHODS: This is a prospective, single-arm, open-label pilot study that enrolled patients with obesity to assist in weight reduction following an SG performed > 12 months prior. For the SNAP, self-assembling magnets were deployed into the ileum (laparoscopically) and duodenum (per-oral endoscopy). Magnets were coupled under laparoscopic and fluoroscopic guidance to create a compression anastomosis. The primary endpoints were technical feasibility, weight loss, and rate of serious adverse events (SAEs). RESULTS: Successful duodeno-ileal diversions were created with SNAP in 27 participants (mean age: 50.6 ± 9.1, mean BMI: 38.1 ± 4.6 kg/m2) with no device-related serious adverse events. Upper endoscopy at 3 months confirmed patent, healthy anastomoses in all patients. At 9 months, patients (n = 24) experienced 11.9 ± 6.2%, 14.5 ± 10.8%, and 17.0 ± 13.9% TBWL at 3, 6, and 9 months, respectively. There were no device-related SAEs. CONCLUSION: The SNAP is technically feasible and relatively safe, with all patients presenting widely patent anastomosis at 3 months. Patients experienced a progressive, clinically meaningful weight loss. Further studies are needed to confirm our findings.
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INTRODUCTION: Intragastric balloon (IGB) is a minimally invasive and reversible option for obesity treatment. There is a worldwide growing number of different IGB models. The efficacy and safety profile for each model must be demonstrated. We aim to evaluate IGB safety profile according to the experience of the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: A survey of 37 IGBs safety-related questions was sent to all GETTEMO members, to retrospectively collect a multicenter Spanish registry. Incidence, causes, and resolution of both major and minor complications and adverse events (AEs), including legal consequences, differentiated for each balloon model were evaluated. Secondary outcome was weight loss data to confirm efficacy. RESULTS: Twenty-one Spanish hospitals experienced in IGBs responded. The overall data encompassed 20,680 IGBs, including 12 different models. Mean %TBWL of 17.66 ± 2.5% was observed. Early removal rate due to intolerance was 3.62%. Mean major complications rate was 0.70% (> 1% in Spatz2, HB, and Spatz3 models), mainly complicated gastric ulcer. Minor AEs rate was 6.37%, mainly esophagitis. Nine cases (0.04%) required surgery. A single case of mortality (0.0048%) occurred. Seven lawsuits (0.0034%) were received, all with favorable resolution. CONCLUSIONS: In the Spanish experience accumulating 20,680 IGBs and including 12 different balloon models, a low incidence rate of major complications and minor AEs are observed (0.70% and 6.37%, respectively), mostly resolved with medical/endoscopic management. IGB shows good tolerance and efficacy profile. These safety data are within the accepted quality standards.
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Balão Gástrico , Obesidade Mórbida , Redução de Peso , Humanos , Espanha/epidemiologia , Estudos Retrospectivos , Feminino , Obesidade Mórbida/cirurgia , Masculino , Adulto , Pessoa de Meia-Idade , Resultado do Tratamento , Complicações Pós-Operatórias/epidemiologia , Sistema de RegistrosRESUMO
[This corrects the article DOI: 10.1016/j.jhepr.2019.10.006.].
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BACKGROUND AND AIMS: Endoscopic sleeve gastroplasty (ESG) is an effective, minimally invasive gastric remodeling procedure to treat mild and moderate obesity. Early adoption of ESG may be desirable to try to halt progression of obesity, but there are few data on its efficacy and safety for overweight patients. METHODS: This was a multicenter, international, analytical case series. Six U.S., 1 Brazilian, 1 Mexican, and 1 Indian center were included. Overweight patients according to local practice undergoing ESG were considered eligible for the study. The end points were percent total weight loss (%TWL), body mass index (BMI) reduction, rate of BMI normalization, and rate of adverse events. RESULTS: One hundred eighty-nine patients with a mean age of 42.6 ± 14.1 years and a mean BMI of 27.79 ± 1.17 kg/m2 were included. All procedures were successfully accomplished, and there were 3 intraprocedural adverse events (1.5%). The mean %TWL was 12.28% ± 3.21%, 15.03% ± 5.30%, 15.27% ± 5.28%, and 14.91% ± 5.62% at 6, 12, 24, and 36 months, respectively. At 12 and 24 months, 76% and 86% of patients achieved normal BMI, with a mean BMI reduction of 4.13 ± 1.46 kg/m2 and 4.25 ± 1.58 kg/m2. There was no difference in mean %TWL in the first quartile versus the fourth quartile of BMI in any of the time points. However, the BMI normalization rate was statistically higher in the first group at 6 and 12 months (6 months, 100% vs 48.5% [P < .01]; 12 months, 86.2% vs 50% [P < .01]; 24 months, 84.6% vs 76.1% [P = .47]; 36 months, 86.3% vs 66.6% [P = .26]). CONCLUSIONS: ESG is safe and effective in treating overweight patients with high BMI normalization rates. It could help halt or delay the progression to obesity.
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Gastroplastia , Obesidade Mórbida , Humanos , Adulto , Pessoa de Meia-Idade , Gastroplastia/métodos , Sobrepeso/cirurgia , Sobrepeso/etiologia , Resultado do Tratamento , Obesidade/cirurgia , Endoscopia/métodos , Redução de Peso , Obesidade Mórbida/cirurgiaRESUMO
Video 1Endoscopic resection of a gastric GI stromal tumor using the helix-snaring technique.
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Bariatric endoscopy treats obesity as a disease, in addition to its multiple associated comorbidities, so it should be considered in the "care-curative" field and not as "satisfying, voluntary or outcoming" medicine. Insufficient weight loss cases, or complications may occur. This, in parallel with the greater diffusion of these techniques, results an increase in the risk of complaints and judicial claims, which will presumably grow during next years. In this sense, we consider that all Bariatric Endoscopic Units working with medical-scientific rigor, must be able to be accredited and have legal support by the Scientific Societies. We propose to create a Medical-Legal Advisory Committee, composed of a medical team and a specialized law firm, which allows advising and guiding the endoscopist when incurring in a conflict.
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Cirurgia Bariátrica , Bariatria , Obesidade Mórbida , Humanos , Cirurgia Bariátrica/métodos , Endoscopia Gastrointestinal/métodos , Endoscopia/métodos , Obesidade/cirurgia , Redução de PesoRESUMO
BACKGROUND: intragastric balloons (IGBs) are a minimally invasive, increasingly popular option for obesity treatment. However, there is only one worldwide guideline standardizing the technical aspects of the procedure (BIBC, SOARD 2018). OBJECTIVES: to construct a practical guideline for IGB usage by reproducing and expanding the BIBC survey among the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: a 140-question survey was submitted to all GETTEMO members. Twenty-one Spanish experienced endoscopists in IGBs answered back. Eight topics on patient selection, indications/contraindications, technique, multidisciplinary follow-up, results, safety, and financial/legal aspects were discussed. Consensus was defined as consensus ≥ 70 %. RESULTS: overall data included 20 680 IGBs including 12 different models. Mean age was 42.0 years-old, 79.9 % were women, and the mean preoperative body mass index (BMI) was 34.05 kg/m². Indication in BMI > 25 kg/m², 10 absolute contraindications, and nutritional and medication measures at follow-up were settled. A mean %TBWL (total body weight loss) of 17.66 % ± 2.5 % was observed. Early removal rate due to intolerance was 3.62 %. Adverse event rate was 0.70 % and 6.37 % for major and minor complications with consensual management. A single case of mortality occurred. IGBs were placed in private health, prior contract, and with full and single payment at the beginning. Seven lawsuits (0.034 %) were received, all ran through civil proceeding, and with favorable final resolution. CONCLUSIONS: this consensus based on more than 20 000 cases represents practical recommendations to perform IGB procedures. This experience shows that the device leads to satisfactory weight loss with a low rate of adverse events. Most results are reproducible compared to those obtained by the BIBC.
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Balão Gástrico , Obesidade Mórbida , Humanos , Feminino , Adulto , Masculino , Balão Gástrico/efeitos adversos , Endoscopia Gastrointestinal , Consenso , Redução de Peso , Índice de Massa Corporal , Obesidade Mórbida/cirurgia , Resultado do TratamentoRESUMO
BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an endolumenal, organ-sparing therapy for obesity, with wide global adoption. We aimed to explore the efficacy and safety of ESG with lifestyle modifications compared with lifestyle modifications alone. METHODS: We conducted a randomised clinical trial at nine US centres, enrolling individuals aged 21-65 years with class 1 or class 2 obesity and who agreed to comply with lifelong dietary restrictions. Participants were randomly assigned (1:1·5; with stratified permuted blocks) to ESG with lifestyle modifications (ESG group) or lifestyle modifications alone (control group), with potential retightening or crossover to ESG, respectively, at 52 weeks. Lifestyle modifications included a low-calorie diet and physical activity. Participants in the primary ESG group were followed up for 104 weeks. The primary endpoint at 52 weeks was the percentage of excess weight loss (EWL), with excess weight being that over the ideal weight for a BMI of 25 kg/m2. Secondary endpoints included change in metabolic comorbidities between the groups. We used multiple imputed intention-to-treat analyses with mixed-effects models. Our analyses were done on a per-protocol basis and a modified intention-to-treat basis. The safety population was defined as all participants who underwent ESG (both primary and crossover ESG) up to 52 weeks. FINDINGS: Between Dec 20, 2017, and June 14, 2019, 209 participants were randomly assigned to ESG (n=85) or to control (n=124). At 52 weeks, the primary endpoint of mean percentage of EWL was 49·2% (SD 32·0) for the ESG group and 3·2% (18·6) for the control group (p<0·0001). Mean percentage of total bodyweight loss was 13·6% (8·0) for the ESG group and 0·8% (5·0) for the control group (p<0·0001), and 59 (77%) of 77 participants in the ESG group reached 25% or more of EWL at 52 weeks compared with 13 (12%) of 110 in the control group (p<0·0001). At 52 weeks, 41 (80%) of 51 participants in the ESG group had an improvement in one or more metabolic comorbidities, whereas six (12%) worsened, compared with the control group in which 28 (45%) of 62 participants had similar improvement, whereas 31 (50%) worsened. At 104 weeks, 41 (68%) of 60 participants in the ESG group maintained 25% or more of EWL. ESG-related serious adverse events occurred in three (2%) of 131 participants, without mortality or need for intensive care or surgery. INTERPRETATION: ESG is a safe intervention that resulted in significant weight loss, maintained at 104 weeks, with important improvements in metabolic comorbidities. ESG should be considered as a synergistic weight loss intervention for patients with class 1 or class 2 obesity. This trial is registered with ClinicalTrials.gov, NCT03406975. FUNDING: Apollo Endosurgery, Mayo Clinic.
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Gastroplastia , Gastroplastia/efeitos adversos , Gastroplastia/métodos , Humanos , Obesidade/etiologia , Obesidade/cirurgia , Estudos Prospectivos , Resultado do Tratamento , Redução de PesoRESUMO
BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an effective medium-term procedure for obesity treatment. There are no consistent studies confirming persistence of maintained gastric tubular configuration. We determined sleeve duration, gastric reduction degree, and suture persistence at 12-month follow-up. PATIENTS AND METHODS: This is a prospective, single-center study, including patients with obesity undergoing ESG with at least 1-year follow-up, who underwent the following: (1) Barium X-ray study (BS) prior and at 6 months, assessing degree of gastric reduction (severe, moderate, or mild), and (2) gastroscopy at 12 months, accounting the number of persistent sutures (tense, lax, or absent). Secondary outcomes were weight loss data and procedure safety profile. RESULTS: Thirty-eight patients (30 women), median age of 47.0 [40.0-51.0] years, and average baseline BMI of 37.6 [35.5-41.5] kg/m2 were included. Median %TWL of 17.1% [16.1-22.3%] with TWL > 10% in 94.7% of patients was obtained at 1 year. No major AEs were observed. Six months BS was performed on 30 patients: 12 (40.0%), 14 (46.7%), and 4 (13.3%) patients showed severe, moderate, and mild gastric reduction, respectively. Twelve months gastroscopy was performed on 22 patients with 83.64% of sutures persisting (92 of 110, mean 4.2 of 5.0 sutures/patient) and 70.9% with adequate tension. We found intact sutures in 12 patients (54.5%), and 10 patients (45.5%) had some suture detached (average 1.8, r = 1-3). There were no differences in %TWL according to BS reduction (p = 0.662) or number of persistent sutures (p = 0.678). CONCLUSIONS: ESG is an effective and safe weight loss strategy at 12-month follow-up with persistence of most sutures and maintenance of notable gastric reduction and remodeling.
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Gastroplastia , Obesidade Mórbida , Adulto , Feminino , Gastroplastia/métodos , Gastroscopia , Humanos , Masculino , Pessoa de Meia-Idade , Obesidade/cirurgia , Obesidade Mórbida/cirurgia , Estudos Prospectivos , Suturas , Resultado do Tratamento , Redução de PesoRESUMO
AIMS: Duodenal mucosal resurfacing (DMR) is an endoscopic procedure developed to improve metabolic parameters and restore insulin sensitivity in patients with diabetes. Here we report long-term DMR safety and efficacy from the REVITA-1 study. MATERIALS AND METHODS: REVITA-1 was a prospective, single-arm, open-label, multicenter study of DMR feasibility, safety, and efficacy in patients with type 2 diabetes (hemoglobin A1c [HbA1c] of 7.5-10.0% (58-86 mmol/mol)) on oral medication. Safety and glycemic (HbA1c), hepatic (alanine aminotransferase [ALT]), and cardiovascular (HDL, triglyceride [TG]/HDL ratio) efficacy parameters were assessed (P values presented for LS mean change). RESULTS: Mean ± SD HbA1c levels reduced from 8.5 ± 0.7% (69.1 ± 7.1 mmol/mol) at baseline (N = 34) to 7.5 ± 0.8% (58.9 ± 8.8 mmol/mol) at 6 months (P < 0.001); and this reduction was sustained through 24 months post-DMR (7.5 ± 1.1% [59.0 ± 12.3 mmol/mol], P < 0.001) while in greater than 50% of patients, glucose-lowering therapy was reduced or unchanged. ALT decreased from 38.1 ± 21.1 U/L at baseline to 32.5 ± 22.1 U/L at 24 months (P = 0.048). HDL and TG/HDL improved during 24-months of follow-up. No device- or procedure-related serious adverse events, unanticipated device effects, or hypoglycemic events were noted between 12 and 24 months post-DMR. CONCLUSIONS: DMR is associated with durable improvements in insulin sensitivity and multiple downstream metabolic parameters through 24 months post-treatment in type 2 diabetes. Clinical trial reg. no. NCT02413567, clinicaltrials.gov.
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Diabetes Mellitus Tipo 2 , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/cirurgia , Duodeno/química , Duodeno/metabolismo , Duodeno/cirurgia , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes/uso terapêutico , Estudos Prospectivos , Resultado do TratamentoRESUMO
INTRODUCTION: Argon plasma coagulation (APC) alone is effective and safe at treating weight regain following Roux-en-Y gastric bypass (RYGB). However, technical details of the treatment vary widely among studies. Therefore, we aimed to create good clinical practice guidelines through a modified Delphi consensus, including experts from the collaborative Bariatric Endoscopy Brazilian group. METHODS: Forty-one locally renowned experts were invited to the consensus by email. Experiences of > 150 APC-treated cases or authorship of relevant articles were the eligibility criteria. An initial questionnaire with short-answer questions was distributed to the experts. The organizing committee converted the responses into statements for an online 2-day voting webinar. Consensus was defined as more than 67% of positive answers. Three consecutive voting rounds were planned with discussion and statement refinements between rounds. RESULTS: Thirty-seven experts fulfilled eligibility criteria and attended the live webinar voting. The total number of patients treated by the panel was 12,349. By the third round, all 79 statements reached consensus. The recommendations include the definition of dilated gastrojejunal anastomosis as ≥ 15 mm, minimum regain of 20% of the lost weight to indicate the APC therapy, 6 to 8 weeks as the ideal interval between ablation sessions, and stopping treatment when the stoma reaches < 12 mm of breadth. CONCLUSIONS: This consensus provides several recommendations based on a highly experienced panel of endoscopists. Although it covers most aspects of the treatment, the level of evidence is low for the majority of the statements. Therefore, bariatric endoscopists should be constantly attentive to new evidence on APC treatment.
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Derivação Gástrica , Obesidade Mórbida , Coagulação com Plasma de Argônio/efeitos adversos , Brasil , Consenso , Técnica Delphi , Dilatação Patológica/cirurgia , Endoscopia Gastrointestinal , Derivação Gástrica/efeitos adversos , Humanos , Obesidade Mórbida/cirurgia , Reoperação , Resultado do Tratamento , Aumento de PesoRESUMO
Background Obesity is the most well-established and prolonged pandemic in modern society. Having a better understanding of the available tools is important to improve weight loss and make the strategies more productive. This study aims to evaluate the effect of intragastric balloon (IGB) on gastric emptying time, its relationship with weight loss after IGB removal, and weight maintenance after six years. Methodology This prospective study analyzed data from patients undergoing IGB placement. A six-years follow-up was performed and data about weight maintenance were collected. We analyzed the impact of the IGB on gastrointestinal motility and its correlation with weight loss. Results Of the 20 patients included in the study, 52.4% were diagnosed with class I obesity and 47.6% with class II obesity. The mean weight of the patients was 96.5 ± 11.9 kg at baseline, 79.6 ± 11.4 kg at the time of IGB removal, 81.8 ± 9.1 kg at six months, and 93.2 ± 14.3 kg six years after IGB removal. The mean difference between the initial weight and that measured immediately after IGB removal was 16.68 ± 5.71 kg. Regarding gastric emptying time, there was a difference in retention on comparing the measurement before balloon placement to that after the balloon was in place (72.9% vs. 86.8%) after one hour of food intake. Comparing two hours after food intake, patients before IGB placement had a 30.6% food retention, while patients with IGB in place had a 69.2% retention. Conclusions In patients with class I or II obesity, the use of an IGB delayed gastric emptying of foods but showed no direct correlation with weight loss. Weight loss achieved after IGB placement was maintained in half of the patients at a six-year follow-up.
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OBJECTIVE: Hydrothermal duodenal mucosal resurfacing (DMR) is a safe, outpatient endoscopic procedure. REVITA-2, a double-blind, superiority randomised controlled trial, investigates safety and efficacy of DMR using the single catheter Revita system (Revita DMR (catheter and system)), on glycaemic control and liver fat content in type 2 diabetes (T2D). DESIGN: Eligible patients (haemoglobin A1c (HbA1c) 59-86 mmol/mol, body mass index≥24 and ≤40 kg/m2, fasting insulin >48.6 pmol/L, ≥1 oral antidiabetic medication) enrolled in Europe and Brazil. Primary endpoints were safety, change from baseline in HbA1c at 24 weeks, and liver MRI proton-density fat fraction (MRI-PDFF) at 12 weeks. RESULTS: Overall mITT (DMR n=56; sham n=52), 24 weeks post DMR, median (IQR) HbA1c change was -10.4 (18.6) mmol/mol in DMR group versus -7.1 (16.4) mmol/mol in sham group (p=0.147). In patients with baseline liver MRI-PDFF >5% (DMR n=48; sham n=43), 12-week post-DMR liver-fat change was -5.4 (5.6)% in DMR group versus -2.9 (6.2)% in sham group (p=0.096). Results from prespecified interaction testing and clinical parameter assessment showed heterogeneity between European (DMR n=39; sham n=37) and Brazilian (DMR n=17; sham n=16) populations (p=0.063); therefore, results were stratified by region. In European mITT, 24 weeks post DMR, median (IQR) HbA1c change was -6.6 mmol/mol (17.5 mmol/mol) versus -3.3 mmol/mol (10.9 mmol/mol) post-sham (p=0.033); 12-week post-DMR liver-fat change was -5.4% (6.1%) versus -2.2% (4.3%) post-sham (p=0.035). Brazilian mITT results trended towards DMR benefit in HbA1c, but not liver fat, in context of a large sham effect. In overall PP, patients with high baseline fasting plasma glucose ((FPG)≥10 mmol/L) had significantly greater reductions in HbA1c post-DMR versus sham (p=0.002). Most adverse events were mild and transient. CONCLUSIONS: DMR is safe and exerts beneficial disease-modifying metabolic effects in T2D with or without non-alcoholic liver disease, particularly in patients with high FPG. TRIAL REGISTRATION NUMBER: NCT02879383.
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Ablação por Cateter , Diabetes Mellitus Tipo 2/terapia , Duodeno/cirurgia , Ressecção Endoscópica de Mucosa , Hipertermia Induzida , Mucosa Intestinal/cirurgia , Adulto , Idoso , Diabetes Mellitus Tipo 2/sangue , Método Duplo-Cego , Estudos de Viabilidade , Feminino , Hemoglobinas Glicadas/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
BACKGROUND AND AIMS: The COVID-19 pandemic has led health institutions to cancel many of the activities including training in different fields. Most practices and training programs have been encouraged to use teleproctoring as an alternative method to enhance physician's ability and assure training. We aimed to evaluate remote training program for endoscopy sleeve gastroplasty (ESG). METHODS: Ten consecutive patients underwent an endoscopic sleeve gastroplasty procedure guided by a proctor expert using an online platform. A stepwise approach was created to assure skill acquisition. RESULTS: All cases were safely performed with no serious adverse events under teleproctoring. The average surgical and suturing times significantly decreased during the training model. From the first 5 cases to the last 5 ones, the endoscopic procedure time decreased from 120 to 93.4 min while suturing time from 92.8 to 68.4 min. The effect size was large in both cases, and the changes were meaningful according to the fitted learning curves. CONCLUSIONS: The proposed teleproctoring program was effective to deliver advanced endoscopic skills such as endosuturing for ESG, despite the restrictions imposed by the COVID-19 pandemic.
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COVID-19 , Gastroplastia , Obesidade Mórbida , Endoscopia , Humanos , Obesidade/cirurgia , Obesidade Mórbida/cirurgia , Pandemias , SARS-CoV-2 , Resultado do TratamentoRESUMO
BACKGROUND AND AIMS: Endoscopic transoral outlet reduction (TORe) has been used to manage weight regain after Roux-en-Y gastric bypass. We conducted a meta-analysis to summarize the efficacy and safety of the two most commonly used techniques: full-thickness suturing plus argon plasma mucosal coagulation (ft-TORe) and argon plasma mucosal coagulation alone (APMC-TORe). METHODS: A literature search of publication databases was performed from their inception to February 2020 for relevant studies. The outcomes of interest were percentage total body weight loss, gastrojejunal anastomosis (GJA) diameter, and adverse events (AEs). The pooled effect estimates were analyzed using a random-effects model. Meta-regression was conducted to identify associations between GJA diameter and weight loss. RESULTS: Nine ft-TORe (n = 737) and 7 APMC-TORe (n = 888) studies were included. APMC-TORe was performed as a series of sessions (mean number of sessions ranging from 1.2 to 3), whereas ft-TORe was mostly performed as a single session. Percentage total body weight loss was 8.0% (95% confidence interval [CI], 6.3%-9.7%), 9.5% (95% CI, 8.1%-11.0%), and 5.8% (95% CI, 4.3%-7.1%) after ft-TORe and 9.0% (95% CI, 4.1%-13.9%), 10.2% (95% CI, 8.4%-12.1%), and 9.5% (95% CI, 5.7%-13.2%) after APMC-TORe at 3, 6, and 12 months, respectively, with no weight-loss difference at 3 and 6 months (P > .05). Only one severe AE was observed after APMC-TORe and none after ft-TORe. Stricture formation was the most common AE (ft-TORe 3.3% and APMC-TORe 4.8%, P = .38). All were successfully treated by endoscopic dilation or conservative treatment. Smaller aperture of the post-TORe GJA and greater change in the GJA diameter correlated with greater weight loss in APMC-TORe and numerical trends in ft-TORe. CONCLUSIONS: This meta-analysis demonstrates that both ft-TORe and APMC-TORe offer significant and comparable weight-loss outcomes with a high and comparable safety profile. However, APMC-TORe typically required multiple endoscopic sessions. Identifying a goal for the final and change in GJA diameter could be useful treatment targets.
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Coagulação com Plasma de Argônio , Derivação Gástrica , Jejuno/cirurgia , Obesidade Mórbida , Estômago/cirurgia , Derivação Gástrica/efeitos adversos , Derivação Gástrica/métodos , Gastroscopia , Humanos , Cirurgia Endoscópica por Orifício Natural , Obesidade Mórbida/cirurgia , Gases em Plasma/uso terapêutico , Recidiva , Reoperação , Técnicas de Sutura , Resultado do Tratamento , Aumento de PesoRESUMO
BACKGROUND: Gastric sleeve stenosis (GSS) is reported in .7% to 4% of cases after sleeve gastrectomy. Two endoscopic balloon dilation techniques are available with no clear consensus on the therapeutic approach. OBJECTIVES: To compare the treatment efficacy and safety between hydrostatic and pneumatic balloon dilations for GSS. SETTING: Academic referral centers, United States and a meta-analysis. METHODS: Consecutive patients who presented with GSS and underwent endoscopic hydrostatic and/or pneumatic balloon dilations at 3 tertiary care hospitals were included. Clinical success was defined as an improvement of symptoms that allowed the patient to avoid further interventions. A systematic literature search was performed to identify relevant studies for meta-analysis. RESULTS: Of 46 patients, 13 had pneumatic dilation only, 26 had hydrostatic dilation only, and 7 had pneumatic dilation after failed hydrostatic dilation. Clinical success was not significantly different among the 3 groups with the success rates of 30.8%, 57.6%, and 57.1% (P = .25) after single dilation and 61.5%, 63.6%, and 71.4% (P = .90) after serial dilations in the pneumatic group, hydrostatic group, and pneumatic after failed hydrostatic group, respectively. Patients who failed hydrostatic balloon dilation (n = 7) had a success rate of 71.4% with subsequent pneumatic dilation. Two serious adverse events were observed in the pneumatic group, whereas none were observed in the hydrostatic group. A meta-analysis of 16 studies involving 360 patients demonstrated higher clinical success with single pneumatic balloon dilation compared with hydrostatic balloon dilation (62.2% versus 36.4%; P = .007) with higher adverse events (3 versus 0 events). CONCLUSIONS: Hydrostatic balloon dilation should be considered as an initial modality for GSS given its acceptable success rate and high safety profile. In those who fail hydrostatic balloon dilation, a subsequent step-up approach to pneumatic balloon dilation or revisional surgery should be attempted.
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Laparoscopia , Obesidade Mórbida , Constrição Patológica/cirurgia , Dilatação , Gastrectomia , Humanos , Estudos Multicêntricos como Assunto , Obesidade Mórbida/cirurgia , Estudos Retrospectivos , Resultado do TratamentoRESUMO
Bariatric endoscopy (BE) encompasses a number of techniques -some consolidated, some under development- aiming to contribute to the management of obese patients and their associated metabolic diseases as a complement to dietary and lifestyle changes. To date different intragastric balloon models, suture systems, aspiration methods, substance injections and both gastric and duodenal malabsorptive devices have been developed, as well as endoscopic procedures for the revision of bariatric surgery. Their ongoing evolution conditions a gradual increase in the quantity and quality of scientific evidence about their effectiveness and safety. Despite this, scientific evidence remains inadequate to establish strong grades of recommendation allowing a unified perspective on prophylaxis in BE. This dearth of data conditions leads, in daily practice, to frequently extrapolate the measures that are used in bariatric surgery (BS) and/or in general therapeutic endoscopy. In this respect, this special article is intended to reach a consensus on the most common prophylactic measures we should apply in BE. The methodological design of this document was developed while attempting to comply with the following 5 phases: Phase 1: delimitation and scope of objectives, according to the GRADE Clinical Guidelines. Phase 2: setup of the Clinical Guide-developing Group: national experts, members of the Grupo Español de Endoscopia Bariátrica (GETTEMO, SEED), SEPD, and SECO, selecting 2 authors for each section. Phase 3: clinical question form (PICO): patients, intervention, comparison, outcomes. Phase 4: literature assessment and synthesis. Search for evidence and elaboration of recommendations. Based on the Oxford Centre for Evidence-Based Medicine classification, most evidence in this article will correspond to level 5 (expert opinions without explicit critical appraisal) and grade of recommendation C (favorable yet inconclusive recommendation) or D (inconclusive or inconsistent studies). Phase 5: External review by experts. We hope that these basic preventive measures will be of interest for daily practice, and may help prevent medical and/or legal conflicts for the benefit of patients, physicians, and BE in general.
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Cirurgia Bariátrica , Balão Gástrico , Endoscopia , Medicina Baseada em Evidências , Humanos , Obesidade/prevenção & controleRESUMO
BACKGROUND: Gastroesophageal reflux disease is defined by the abnormal presence of gastric content in the esophagus, with 10% incidence in the Western population, being fundoplication one treatment option. AIM: To evaluate the early (six months) and late (15 years) effectiveness of laparoscopic fundoplication, the long term postoperative weight changes, as well as the impact of weight gain in symptoms control. METHODS: Prospective study of 40 subjects who underwent laparoscopic Nissen's fundoplication. Preoperatively and early postoperatively, clinical, endoscopic, radiologic, manometric and pHmetric evaluations were carried out. After 15 years, clinical and endoscopic assessments were carried out and the results compared with the early ones. The presence or absence of obesity was stratified in both early and late phases, and its influence in the long-term results of fundoplication was studied, measuring quality of life according to the Visick criteria. RESULTS: The mean preoperative ages, weight, and body mass index were respectively, 51 years, 69.67 kg and 25.68 kg/m2. The intraoperative and postoperative complications rates were 12.5% and 15%, without mortality. In the early postoperative period the symptoms were well controlled, hernias and esophagitis disappeared, the lower esophageal sphincter had functional improvement, and pHmetry parameters normalized. In the late follow-up 29 subjects were assessed. During this period there was adequate clinical control of reflux regardless of weight gain. In both time periods Visick criteria improved. CONCLUSION: Fundoplication was safe and effective in early and late periods. There was late weight gain, which did not influence effective symptoms control.