Informed consent for endoscopic procedures: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement.

All endoscopic procedures are invasive and carry risk. Accordingly, all endoscopists should involve the patient in the decision-making process about the most appropriate endoscopic procedure for that individual, in keeping with a patient's right to self-determination and autonomy. Recognition of this has led to detailed guidelines on informed consent for endoscopy in some countries, but in many no such guidance exists; this may lead to variations in care and exposure to risk of litigation. In this document, the European Society of Gastrointestinal Endoscopy (ESGE) sets out a series of statements that cover best practice in informed consent for endoscopy. These statements should be seen as a minimum standard of practice, but practitioners must be aware of and adhere to the law in their own country. 1: Patients should give informed consent for all gastrointestinal endoscopic procedures for which they have capacity to do so. 2: The healthcare professional seeking consent for an endoscopic procedure should ensure that the patient has the capacity to consent to that procedure. 3: For patients who lack capacity, healthcare personnel should at all times try to engage with people close to the patient, such as family, friends, or caregivers, to achieve consensus on the appropriateness of performing the procedure. 4: Where a patient lacks capacity to provide informed consent, the best interest decision should be clearly documented in the medical record. This should include information about the capacity assessment, reason(s) that the decision cannot be delayed for capacity recovery (or if recovery is not expected), who has been consulted, and where relevant the form of authority for the decision. 5: There should be a systematic and transparent disclosure of the expected benefits and harms that may reasonably affect patient choice on whether or not to undergo any diagnostic or interventional endoscopic procedure. Information about possible alternatives, as well as the consequences of doing nothing, should also be provided when relevant. 6: The information provided on the benefit and harms of an endoscopic procedure should be adapted to the procedure and patient-specific risk factors, and the preferences of the patient should be central to the consent process. 7: The consent discussion should be undertaken by an individual who is familiar with the procedure and its risks, and is able to discuss these in the context of the individual patient. 8: Patients should confirm consent to an endoscopic procedure in a private, unrushed, and non-coercive environment. 9: If a patient requests that an endoscopic procedure be discontinued, the procedure should be paused and the patient's capacity for decision making assessed. If a competent patient continues to object to the procedure, or if a conclusive determination of capacity is not feasible, the examination should be terminated as soon as it is safe to do so. 10: Informed consent should be sufficiently detailed to cover all findings that can be reasonably anticipated during an endoscopic examination. The scope of this consent should not be expanded, nor a patient's implicit consent for additional interventions assumed, unless failure to proceed with such interventions would result in immediate and predictable harm to the patient.

Safety of Endoscopic Sleeve Gastroplasty with a Single-Channel Endoscope.

PURPOSE: Less invasive endoscopic bariatric procedures are under development for the management of class I of obesity. The purpose of our study is to evaluate the safety of endoscopic sleeve gastroplasty (ESG) using the new suturing device OverStitch Sx™. MATERIALS AND METHODS: This is a retrospective single-center study over 191 patients using the ESG under general anesthesia with overnight inpatient observation between January 2019 and December 2020. The analyzed variables were adverse effects and change in body weight at 6 and 12 months of follow-up. RESULTS: A total of 191 patients underwent ESG for primary obesity. There were 173 female (90.6%) with a mean age of 36.9 years. The mean BMI was 33.7 kg/m2 (range: 28.9-54). There were no major intra-procedure adverse events. There were two postprocedural complications (1.04%), a transparietal suturing of falciform ligament which needed laparoscopic exploration for severe abdominal pain and a perigastric collection with antibiotic treatment, both with favorable outcome. Considering the weight loss results, the %TWL recorded was 22.4% for 84 patients (43.9%, 6 months' follow-up) and 18.7% for 69 patients (36.1%, 12 months' follow-up) with the mean EWL of 41.6% and respectively 34.7%. A total of 59 patients (30.9%) were lost follow-up and 12 patients underwent revisional bariatric procedure. According to ASGE definition, 53.8% (n = 71) reached > 25% of EWL. CONCLUSION: Endoscopic gastroplasty represents a safe minimal invasive approach with the new device OverStitch Sx™ that can be considered an effective and well-tolerated procedure especially for primary obesity treatment.

Impact of the COVID-19 pandemic on gastrointestinal endoscopy activity in France.

BACKGROUND: The SARS-CoV-2 pandemic has majorly affected medical activity around the world. We sought to measure the impact of the COVID-19 pandemic on gastrointestinal (GI) endoscopy activity in France. METHODS: We performed a web-based survey, including 35 questions on the responders and their endoscopic practice, from 23 March to 27 March 2020, sent to the 3300 French gastroenterologists practicing endoscopy. RESULTS: 694 GI endoscopists (21 %) provided analyzable data; of these, 29.4 % (204/694) were involved in the management of COVID-19 patients outside the endoscopy department. During the study period, 98.7 % (685/694) of endoscopists had had to cancel procedures. There were 89 gastroenterologists (12.8 %) who reported symptoms compatible with COVID-19 infection, and a positive PCR test was recorded in 12/197 (6.1 %) vs. 3/497 (0.6 %) endoscopists in the high vs. low prevalence areas, respectively (P < 0.001). CONCLUSIONS: The COVID-19 pandemic led to a major reduction in the volume of GI endoscopies performed in France in March 2020. The prolonged limited access to GI endoscopy could lead to a delay in the management of patients with GI cancers.

Multicenter Randomized Study of Obesity Treatment with Minimally Invasive Injection of Hyaluronic Acid Versus and Combined with Intragastric Balloon.

BACKGROUND: Research into minimally invasive techniques is worthwhile for greater acceptance in bariatric surgery, a useful first step being to evaluate the combination of these with current procedures. We suggest that intragastric balloon (IGB) can be performed with hyaluronic acid (HA) injections at the level of the gastroesophageal junction. METHODS: A submucosal restriction is created by circular injection of an absorbable material within a defined area based on endoscopic anatomy. We included 101 patients in a prospective multicenter randomized trial, with average body mass index (BMI) 33.4 (range 27-44), treated from April 2010 to April 2012 by IGB and/or HA injection, sequentially, and followed for two more years. Patients were divided into group 1 (IGB alone), group 2 (IGB followed by HA at IGB removal, at 6 months), and group 3 (HA and IGB at 6 months). RESULTS: BMI loss at 6 months was inferior in the HA group (32 patients) compared with the IGB groups (68 patients) (2.1 ± 0.4 versus 3.4 ± 0.3, p < 0.05). The efficacy of IGB alone compared with combined treatments (groups 2 and 3) was significantly inferior at 18 months only, but the impact of the treatment sequence (HA before or after IGB) on BMI loss was not statistically significant, although in favor of HA first. CONCLUSIONS: This study did not demonstrate the efficacy of HA injections as an obesity treatment.