Bariatric endoscopy, care-curative medicine and legal conflicts. Spanish Bariatric Endoscopy Group (Gettemo-SEED) Positioning.

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.

Spanish Intragastric Balloon Consensus Statement (SIBC): practical guidelines based on experience of over 20 000 cases.

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.

Spanish Intragastric Balloon Consensus Statement (SIBC): practical guidelines based on experience of over 20 000 cases

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 (AU)

Persistence of Sutures and Gastric Reduction After Endoscopic Sleeve Gastroplasty: Radiological and Endoscopic Assessment.

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.

Endoscopic sleeve gastroplasty, laparoscopic sleeve gastrectomy, and laparoscopic greater curve plication: do they differ at 2 years?

BACKGROUND: Endoscopic sleeve gastroplasty (ESG) is an effective treatment option for obesity. However, data comparing its efficacy to bariatric surgery are scarce. We aimed to compare the effectiveness and safety of ESG with laparoscopic sleeve gastrectomy (LSG) and laparoscopic greater curve plication (LGCP) at 2 years. METHODS : We reviewed 353 patient records and identified 296 patients who underwent ESG (n = 199), LSG (n = 61), and LGCP (n = 36) at four centers in Spain between 2014 and 2016. We compared their total body weight loss (%TBWL) and safety over 2 years. A linear mixed model (LMM) was used to analyze repeated measures of weight loss outcomes at 6, 12, 18, and 24 months to compare the three procedures. RESULTS : Among the 296 patients, 210 (ESG 135, LSG 43, LGCP 32) completed 1 year of follow-up and 102 (ESG 46, LSG 34, LGCP 22) reached 2 years. Their mean (standard deviation [SD]) body mass index (BMI) was 39.6 (4.8) kg/m2. There were no differences in age, sex, or BMI between the groups. In LMM analysis, adjusting for age, sex, and initial BMI, we found ESG had a significantly lower TBWL, %TBWL, and BMI decline compared with LSG and LGCP at all time points (P = 0.001). The adjusted mean %TBWL at 2 years for ESG, LSG, and LGCP were 18.5 %, 28.3 %, and 26.9 %, respectively. However, ESG, when compared with LSG and LGCP, had a shorter inpatient stay (1 vs. 3 vs. 3 days; P < 0.001) and lower complication rate (0.5 % vs. 4.9 % vs. 8.3 %; P = 0.006). CONCLUSION : All three procedures induced significant weight loss in obese patients. Although the weight loss was lower with ESG compared with other techniques, it displayed a better safety profile and shorter hospital stay.

Principales medidas de profilaxis en endoscopia bariátrica. Guía Española de Recomendación de Expertos / No disponible

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Main prophylactic measures in bariatric endoscopy. Spanish Expert Recommendations Guideline.

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.

Retirada difícil del balón intragástrico con colonización fúngica grave: ¿cómo lo hago? Respuesta-comentario del Grupo Español de Endoscopia Bariátrica / Difficult explant of intragastric balloon with severe fungal colonization: How do I do it? Response-commentary of the Spanish Bariatric Endoscopy Group

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Documento español de consenso en endoscopia bariátrica. Parte 2. Tratamientos endoscópicos específicos / Spanish consensus document on bariatric endoscopy. Part 2: specific endoscopic treatments

Durante los últimos años estamos asistiendo a un importante incremento en el número y tipo de técnicas endoscópicas bariátricas: se han propuesto distintos modelos de balones, sistemas de suturas, inyección de sustancias, colocación de prótesis, etc. También se han incorporado técnicas endoscópicas de revisión para aquellos casos de pacientes intervenidos de cirugía bariátrica que presentan recuperación ponderal. Todo ello obliga a la necesidad de protocolizar, posicionar y regularizar todas estas técnicas, mediante un consenso que permita su aplicación clínica con el máximo rigor médico y evidencia científica disponibles. Tras editar una primera parte de Consideraciones Generales, en esta segunda revisaremos las indicaciones, metodología y resultados de cada una las principales técnicas que se realizan en nuestro país, con intención de establecer una base y unos requisitos mínimos que faciliten y favorezcan la correcta práctica diaria de estos procedimientos en las Unidades de Endoscopia Bariátrica

During the last years we have been witnessing a significant increase in the number and type of bariatric endoscopic techniques: we have different types of balloons, suture systems, injection of substances and malabsorptive prosthesis, etc. Also, some endoscopic revisional procedures for patients with weight regain after bariatric surgery have been incorporated. This makes it necessary to protocolize, position and regularize all these techniques, through a consensus that allows their clinical application with the maximum medical rigor and scientific evidence available

Spanish consensus document on bariatric endoscopy. Part 2: specific endoscopic treatments.

During the last years we have been witnessing a significant increase in the number and type of bariatric endoscopic techniques: we have different types of balloons, suture systems, injection of substances and malabsorptive prosthesis, etc. Also, some endoscopic revisional procedures for patients with weight regain after bariatric surgery have been incorporated. This makes it necessary to protocolize, position and regularize all these techniques, through a consensus that allows their clinical application with the maximum medical rigor and scientific evidence available.

Perforación gástrica por balón intragástrico en paciente con funduplicatura de Nissen. Respuesta del Grupo Español de Endoscopia Bariátrica / Gastric perforation by intragastric balloon in a patient with Nissen fundoplication. Response of the Spanish Bariatric Endoscopy Group

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Eficacia y seguridad del TORe mediante sutura endoscópica para tratar la reganancia ponderal tras bypass gástrico quirúrgico en Y-de-Roux / Efficacy and safety of transoral outlet reduction via endoscopic suturing in patients with weight regain after a surgical Roux-en-Y gastric bypass

Introducción: muchos de los pacientes sometidos a cirugía bariátrica (bypass gástrico en Y-de-Roux [RYGB]), con el tiempo, pueden recuperar parte del peso perdido. La reducción transoral del vaciamiento gástrico (TORe) con sutura endoscópica podría ser una alternativa válida en estos pacientes. Métodos: serie inicial retrospectiva que incluye a 13 pacientes consecutivos remitidos por reganancia ponderal tras RYGB y con anastomosis gastroyeyunal dilatada (> 15 mm). El TORe fue realizado mediante un dispositivo endoscópico de suturas transmurales (OverStitch-Apollo(R)), reduciendo el diámetro de la anastomosis y del reservorio gástrico. Se describen los datos iniciales de viabilidad técnica, seguridad y eficacia, con un seguimiento limitado a seis meses. Resultados: tras el RYGB, existía una pérdida media máxima de 37,69 kg y una posterior reganancia media de 21,62 kg. Se redujo el diámetro medio de la anastomosis de 36 mm (rango 20-45) a 9 mm (rango 5-12) (reducción del 75%) con una media de 2,5 suturas y el del reservorio de 7,2 cm (rango 2-10) a 4,7 cm (rango 4-5) (reducción del 34,72%) con una media de 2,7 suturas. La pérdida media de peso a los seis meses tras el TORe fue de 12,29 kg (pérdida del 56,85% del peso reganado tras RYGB). No se registraron complicaciones relacionadas con el procedimiento. Conclusiones: la reducción mediante sutura endoscópica de la anastomosis gastroyeyunal dilatada y del reservorio gástrico parece una opción viable y segura según nuestra limitada experiencia inicial. Dentro de un abordaje multidisciplinar y en un seguimiento a corto plazo, se presenta como una opción mínimamente invasiva y eficaz para controlar la reganancia ponderal tras RYGB

Introduction: many patients that undergo bariatric surgery (Roux-en-Y gastric bypass [RYGB]) may regain some of their weight lost over time. A transoral outlet reduction (TORe) with endoscopic suture could be a valid alternative in these patients. Methods: this was a retrospective initial series of 13 consecutive patients with weight regain after RYGB and a dilated gastro-jejunal anastomosis (> 15 mm). TORe was performed using an endoscopic transmural suture device (OverStitch-Apollo(R)), which was used to reduce the anastomosis aperture and also to treat the gastric pouch. The initial data of feasibility, safety and weight loss are described with a limited follow-up of six months. Results: there was a mean maximum weight loss of 37.69 kg after RYGB and a subsequent average regain of 21.62 kg. The mean anastomosis diameter was 36 mm (range 20-45) which was reduced to 9 mm (range 5-12) (75% reduction), with an average of 2.5 sutures. The mean pouch size was 7.2 cm (range 2-10), which decreased to 4.7 cm (range 4-5) (34.72% reduction), with an average of 2.7 sutures. The mean weight loss six months after TORe was 12.29 kg, a weight loss of 56.85% of the weight regained after RYGB. No complications related to the procedure were recorded. Conclusions: endoscopic suture reduction of the dilated gastro-jejunal anastomosis and the gastric pouch seems a feasible and safe option in our limited initial experience. With a multidisciplinary approach and a short term follow-up, this seems to be a minimally invasive and effective option to control weight regain after RYGB

Documento Español de Consenso en Endoscopia Bariátrica. Parte 1. Consideraciones generales / Spanish Consensus Document on Bariatric Endoscopy. Part 1. General considerations

La obesidad es una enfermedad crónica multifactorial, incurable, recurrente y progresiva, asociada a importantes complicaciones físicas y psicológicas y con considerable morbimortalidad. Por este motivo, deben individualizarse la evaluación, el tratamiento y el seguimiento del paciente obeso dentro de una unidad multidisciplinar que disponga de unos adecuados recursos humanos y estructurales. Su tratamiento médico mediante medidas higiénicas-dietéticas, aunque imprescindible, puede resultar insuficiente y la opción quirúrgica, reservada a obesidades severas o mórbidas, no está exenta de complicaciones ni es del agrado de muchos pacientes. En este contexto, pueden considerarse tres situaciones en las que el tratamiento endoscópico, como estrategia complementaria y con escasas complicaciones, contribuye al beneficio del paciente obeso: en primer lugar, aquel subgrupo de pacientes con sobrepeso grado II u obesidad no mórbida en el que el tratamiento médico aislado haya fracasado o como complemento al mismo; en segundo lugar, en aquellos pacientes con obesidad mórbida que rechacen la cirugía o a los cuales esta les resulte contraindicada o de riesgo excesivo; y finalmente, en aquellos pacientes afectos de superobesidad que necesitan perder peso previo a la cirugía bariátrica para disminuir la morbimortalidad de la misma. En este sentido, el Grupo Español de Endoscopia Bariátrica (Grupo Español de Trabajo para el Tratamiento Endoscópico del Metabolismo y la Obesidad [GETTEMO]) ha elaborado este Documento de Consenso para que sirva de orientación práctica a todos los profesionales implicados en la endoscopia de la obesidad y permita establecer los requisitos mínimos necesarios para el correcto funcionamiento de una Unidad de Endoscopia Bariátrica

La obesidad es una enfermedad crónica multifactorial, incurable, recurrente y progresiva, asociada a importantes complicaciones físicas y psicológicas y con considerable morbimortalidad. Por este motivo, deben individualizarse la evaluación, el tratamiento y el seguimiento del paciente obeso dentro de una unidad multidisciplinar que disponga de unos adecuados recursos humanos y estructurales. Su tratamiento médico mediante medidas higiénicas-dietéticas, aunque imprescindible, puede resultar insuficiente y la opción quirúrgica, reservada a obesidades severas o mórbidas, no está exenta de complicaciones ni es del agrado de muchos pacientes. En este contexto, pueden considerarse tres situaciones en las que el tratamiento endoscópico, como estrategia complementaria y con escasas complicaciones, contribuye al beneficio del paciente obeso: en primer lugar, aquel subgrupo de pacientes con sobrepeso grado II u obesidad no mórbida en el que el tratamiento médico aislado haya fracasado o como complemento al mismo; en segundo lugar, en aquellos pacientes con obesidad mórbida que rechacen la cirugía o a los cuales esta les resulte contraindicada o de riesgo excesivo; y finalmente, en aquellos pacientes afectos de superobesidad que necesitan perder peso previo a la cirugía bariátrica para disminuir la morbimortalidad de la misma. En este sentido, el Grupo Español de Endoscopia Bariátrica (Grupo Español de Trabajo para el Tratamiento Endoscópico del Metabolismo y la Obesidad [GETTEMO]) ha elaborado este Documento de Consenso para que sirva de orientación práctica a todos los profesionales implicados en la endoscopia de la obesidad y permita establecer los requisitos mínimos necesarios para el correcto funcionamiento de una Unidad de Endoscopia Bariátrica

Efficacy and safety of transoral outlet reduction via endoscopic suturing in patients with weight regain after a surgical Roux-en-Y gastric bypass.

INTRODUCTION: many patients that undergo bariatric surgery (Roux-en-Y gastric bypass [RYGB]) may regain some of their weight lost over time. A transoral outlet reduction (TORe) with endoscopic suture could be a valid alternative in these patients. METHODS: this was a retrospective initial series of 13 consecutive patients with weight regain after RYGB and a dilated gastro-jejunal anastomosis (> 15 mm). TORe was performed using an endoscopic transmural suture device (OverStitch-Apollo®), which was used to reduce the anastomosis aperture and also to treat the gastric pouch. The initial data of feasibility, safety and weight loss are described with a limited follow-up of six months. RESULTS: there was a mean maximum weight loss of 37.69 kg after RYGB and a subsequent average regain of 21.62 kg. The mean anastomosis diameter was 36 mm (range 20-45) which was reduced to 9 mm (range 5-12) (75% reduction), with an average of 2.5 sutures. The mean pouch size was 7.2 cm (range 2-10), which decreased to 4.7 cm (range 4-5) (34.72% reduction), with an average of 2.7 sutures. The mean weight loss six months after TORe was 12.29 kg, a weight loss of 56.85% of the weight regained after RYGB. No complications related to the procedure were recorded. CONCLUSIONS: endoscopic suture reduction of the dilated gastro-jejunal anastomosis and the gastric pouch seems a feasible and safe option in our limited initial experience. With a multidisciplinary approach and a short term follow-up, this seems to be a minimally invasive and effective option to control weight regain after RYGB.

Spanish Consensus Document on Bariatric Endoscopy. Part 1. General considerations.

Obesity is a chronic multifactorial, incurable, recurrent, and progressive disease associated with significant physical and psychological complications, and considerable morbidity and mortality. For this reason, the assessment, management, and follow-up of obese patients should take place in the setting of a multidisciplinary unit equipped with adequate human and structural resources. Medical treatment using hygienic-dietary measures, while indispensable, may be insufficient, and surgery, which is reserved for severe or morbid obesity, is not exempt from complications neither is to the liking of many patients. In this context three situations may be considered where endoscopic treatment, used as a supplementary strategy with few complications, contributes to benefit obese patients: first, in a subgroup of patients with grade-II overweight or non-morbid obesity where medical therapy alone failed or needs supplementation. Second, in patients with morbid obesity when surgery is rejected, is contraindicated, or entails excessive risk. Finally, in patients with superobesity who need to lose weight before bariatric surgery in order to reduce surgery-related morbidity and mortality. In this regard, the Spanish Task Force on Bariatric Endoscopy (Grupo Español de Trabajo para el Tratamiento Endoscópico del Metabolismo y la Obesidad, GETTEMO) have developed this Consensus Document to serve as practical guidance for all professionals involved in the endoscopic management of obesity, and to facilitate establishing a minimum set of requirements for the proper functioning of a bariatric endoscopy unit.

Nuevo balón intragástrico ingerible (Elipse(R)). ¿Café para todos? Posicionamiento de GETTEMO / A new swallowable intragastric balloon (Elipse(R)). Coffee for everybody? The position of GETTEMO

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A new swallowable intragastric balloon (Elipse®). Coffee for everybody? The position of GETTEMO.

Recently, the Elipse® swallow balloon with spontaneous evacuation has been incorporated. GETTEMO wants to position defending innovations in endoscopic treatment of bariatric patients, including this new gastric balloon. Any bariatric endoscopic procedure must always be done within a suitable protocol and in a Multidisciplinary Unit. In order to ensure maximum safety and to be able to effectively solve potential complications, in most of the cases a prior endoscopy should be required to rule out complications, the balloon must be implanted (or supervised) by a bariatric endoscopist and it is necessary to have an Endoscopic Emergency Department.