Effectiveness and safety of a 1L polyethylene glycol and ascorbic acid preparation for colonoscopy in routine clinical practice in Spain.

BACKGROUND AND AIMS: Large clinical trials and small real-world studies show that a 1L polyethylene glycol and ascorbic acid solution (1L PEG-ASC) is an effective and safe bowel preparation for colonoscopy. Here, the effectiveness and safety of 1L PEG-ASC was evaluated in a large cohort of patients in routine clinical practice in Spain. METHODS: A sub-analysis was performed in an observational, multicenter, retrospective study assessing the effectiveness and safety of 1L PEG-ASC in adult patients undergoing a colonoscopy at 10 centers in Spain. Cleansing quality was assessed with the Boston Bowel Preparation Scale, scores ≥6 with all segmental scores ≥2 was considered adequate colon cleansing, high-quality was considered as cleansing ≥8 or =3 in the right colon. Polyp and adenoma detection rates, and adverse events were also assessed. RESULTS: Data was collected from 7160 patients: 48.3% males; mean age 58.0, 33.6% ≥65 years old. Adequate overall bowel cleansing was achieved in 95.6% of patients (95% CI 95.1%-96.0%), high quality cleansing in 74.4% (95% CI 73.4%-75.4%) and high-quality right colon cleansing in 66.0% (95% CI 64.9-67.1). The adequate overall cleansing rate was 97.0% with a split-dose and 94.0% with same-day regimen (P<0.0001), and high-quality right colon cleansing was 69.0% and 62.5% (P<0.0001), respectively. Colonoscopy was completed in 97.2% of cases. A multivariate regression analysis revealed that an overnight split-dose regimen and age <65 years were independent predictors of adequate bowel cleansing of the overall colon, age <65 years and female gender were independent predictors of HQ cleansing of the overall colon, and the three covariates were independent predictors of HQ cleansing of the right colon. At least one adverse event was experienced by 3.3% of participants, with nausea (1.5%) and vomiting (1.2%) being the most frequent. CONCLUSION: This sub-analysis confirmed 1L PEG-ASC to be an effective and safe bowel cleansing preparation in a real world setting in Spain.

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.

Adult-onset Morgagni's hernia.

We report the case of a 65-year-old male patient with Down's syndrome and a deep venous thrombosis on anticoagulation with acenocoumarol. The case presented due to nonspecific, predominantly postprandial epigastric discomfort, meteorism and aerophagia. A thoracoabdominal computed tomography (CT) scan revealed a Morgagni hernia with a cephalad migration of part of the stomach, ascending colon and transverse colon. After laparotomy, the defect was repaired using a titanium mesh and the patient had a favorable outcome.

Evaluating the Safety of the Intragastric Balloon: Spanish Multicenter Experience in 20,680 Cases and with 12 Different Balloon Models.

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.

Bowel cleansing effectiveness and safety of 1L PEG + Asc in the real-world setting: Observational, retrospective, multicenter study of over 13000 patients.

Background and study aims Effective bowel cleansing is critical for detecting lesions during colonoscopy, highlighting the importance of bowel preparations. 1L polyethylene glycol (PEG) + ascorbate (Asc) is the only recommended 1L PEG product in Europe and the United States. Its efficacy was demonstrated in large-scale controlled trials and confirmed in smaller-scale real-world studies. However, no large-scale real-world data exist. Patients and methods This observational, retrospective, multicenter study, used outpatient follow-up data from medical records from 10 centers in Spain and two in Portugal. Outpatients aged ≥18 years using 1L PEG + Asc as bowel preparation were included. The main outcome measures were overall adequate colon cleansing (Boston Bowel Preparation Scale [BBPS] score ≥6 with BBPS score ≥2 in each segment) and high-quality cleansing of the right colon (BBPS score=3). Results Data from 13169 eligible patients were included. Overall cleansing success was achieved in 89.3% (95%CI 88.7%-89.8%) and high-quality cleansing in the right colon in 49.3% (95%CI 48.4%-50.2%) of patients. For the overnight split-dose and same-day regimens, overall adequate quality cleansing success rate was 94.7% and 86.7% ( P <0.0001) and high-quality cleansing of the right colon rate was 65.4% and 41.4% ( P <0.0001), respectively. Colonoscopy was completed in 97.3% of patients, with non-completion due to poor preparation in only 0.8%; 2.3% of patients experienced at least one adverse event (AE). Conclusions This large-scale, real-world study demonstrates the effectiveness of 1L PEG + Asc in the total and right colon, with a low percentage of patients with AEs in routine clinical practice.

[Study of celiac disease in adults with type 1 diabetes mellitus]. / Estudio de enfermedad celíaca en pacientes adultos con diabetes mellitus de tipo 1.

Celiac disease (CD) presents a wide clinical spectrum. There are asymptomatic or oligosymptomatic forms, which are difficult to diagnose. Since patients with untreated CD can develop severe complications, early diagnosis of these forms is important. Consequently, in groups at risk for CD, such as patients with type 1 diabetes (DM1), screening through determination of antigliadin (AGA), anti-tissue transglutaminase (ATG) and antiendomysial antibodies (EMA) is recommended. In the present study, 463 DM1 patients were screened for these antibodies. Patients who were positive for one or more were offered an upper endoscopy to obtain distal duodenum biopsies. Histological lesions, when present, were classified using Marsh's classification. Of the 463 patients, 62 (13.4%) were positive for at least one of the three antibodies, and 42 accepted to undergo an endoscopy. Fourteen patients (3% of the DM1 patients) were histologically diagnosed with CD. Most of these patients had no symptoms of CD, although some showed laboratory findings frequent in CD. The presence of clinical or analytical data compatible with CD was independent of the grade of histological lesions. Finally, we calculated the sensitivity and positive predictive value for each antibody. The most sensitive were ATG and EMA. Because of the technical simplicity of determining ATG with ELISA, in our opinion, this test should be the option of choice for screening.

Hernia de Morgagni de presentación en la edad adulta / Adult-onset Morgagni's hernia

No disponible

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)

Estudio de enfermedad celíaca en pacientes adultos con diabetes mellitus de tipo 1 / Study of celiac disease in adults with type 1 diabetes mellitus

En el presente estudio determinamos los citados anticuerpos a 463 pacientes con DM1 y, a los que presentaban positividad para alguno de ellos, se les propuso la realización de una endoscopia con toma de biopsias de duodeno distal, y se clasificaron las lesiones histológicas, cuando existieron, según la clasificación de Marsh.Sesenta y dos de los 463 (13,4%) pacientes presentaron al menos uno de los 3 anticuerpos positivo y, de ellos, 42 accedieron a la realización de la endoscopia. En 14 pacientes (3% de los diabéticos) se encontraron alteraciones histológicas compatibles con EC. La mayoría de estos 14 pacientes no refería síntomas relacionados con la enfermedad, aunque varios presentaban alteraciones analíticas presentes frecuentemente en la EC. La existencia de datos clinicoanalíticos compatibles con EC fue independiente del grado de lesión histológica. Al analizar la sensibilidad y el valor predictivo positivo para cada anticuerpo, los ATG y EMA fueron los más sensibles, si bien la facilidad técnica de detección de los ATG mediante técnicas de ELISA hace, en nuestra opinión, que sea el de elección para la realización del cribado(AU)

Celiac disease (CD) presents a wide clinical spectrum. There are asymptomatic or oligosymptomatic forms, which are difficult to diagnose. Since patients with untreated CD can develop severe complications, early diagnosis of these forms is important. Consequently, in groups at risk for CD, such as patients with type 1 diabetes (DM1), screening through determination of antigliadin (AGA), anti-tissue transglutaminase (ATG) and antiendomysial antibodies (EMA) is recommended. In the present study, 463 DM1 patients were screened for these antibodies. Patients who were positive for one or more were offered an upper endoscopy to obtain distal duodenum biopsies. Histological lesions, when present, were classified using Marsh's classification. Of the 463 patients, 62 (13.4%) were positive for at least one of the three antibodies, and 42 accepted to undergo an endoscopy. Fourteen patients (3% of the DM1 patients) were histologically diagnosed with CD. Most of these patients had no symptoms of CD, although some showed laboratory findings frequent in CD. The presence of clinical or analytical data compatible with CD was independent of the grade of histological lesions. Finally, we calculated the sensitivity and positive predictive value for each antibody. The most sensitive were ATG and EMA. Because of the technical simplicity of determining ATG with ELISA, in our opinion, this test should be the option of choice for screening (AU)