end-ball INFORMATION AND PATIENT FOLLOW-UP
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Intra-gastric Balloon System Moving towards a healthier life! INFORMATION AND PATIENT FOLLOW-UP INS137 v1

INTRODUCTION The “END BALL” intra-gastric balloon enables you to take advantage of a non-drug, nonsurgical approach to losing weight. It is a “starter” which will give you a feeling of satiety. By combining it with your motivation and a nutritional treatment you will enjoy greater weight loss and you will learn the principles of long-lasting succes

Principle: The intra-gastric balloon occupies a volume of the stomach causing a feeling of satiety and a reduction in food intake. The treatment must be combined with dietary and behavioural management. • Non chirurgical : Insertion by an endoscopic procedure1 • Characteristics : Non-sterile, single use only, biocompatible, radioopaque filled with air and water • Expected weight loss : The expected weight loss at 6 months is in the order of 34% of the excess weight, which corresponds to a weight loss of about 16 kg. There are currently no studies on the maintenance of weight loss over time...

• Contraindications : The presence of one of the following conditions contraindicates the insertion of a balloon : ^ history of gastric surgery ^ digestive pathology: large hiatus hernias (> 5 cm), active peptic ulcers, severe oesophagitis of Grade III or IV (Savary-Miller classification) or Grade C or D (Los Angeles classification), Crohn's disease or any other digestive tract lesion which could bleed, pyloric stenosis and abnormalities of the structure of the digestive tract ^ diseases that are life-threatening short-term and medium-term ^ severe cognitive or mental disorders ^ severe,...

Principal complications: Complications related to balloon deployment or removal: • Above and beyond complications due to the upper digestive tract endoscopy (perforation or bleeding, bronchial inhalation as a result of gastric reflux, arrhythmia) or the anaesthetic, other complications are specifically associated with deployment and extraction of the balloon: - Damage to the pharynx or oesophagus, - Damage to the stomach wall, - Perforation of the oesophagus, duodenum, ostium cardiacum or stomach wall if the balloon is in the wrong place when it is inflated. Mechanical complications caused...

COMPLICATIONS Functional complications (side effects): Insertion of an intra-gastric balloon is sometimes accompanied in the early days by gastric: - Heaviness, and nausea and vomiting which normally recede in 2 to 7 days. - Symptoms of gastro-esophageal reflux are also possible. These problems can be corrected by appropriate treatment with drugs (anti-secretory medication, anti-nausea drugs). Vomiting may persist necessitating premature removal of the balloon. Metabolic complications: These result from uncontrolled or neglected vomiting which can be the cause of dehydration, metabolic...

THE PROGRAMME Before the procedure : Overall management within a multi-disciplinary team liaising with the attending physician. This team is made up of : ➢ A gastroenterologist: He inserts and extracts the balloon and supports you throughout the treatment ➢ A nutritionist, endocrinologist or dietician: They recommend a formula suitable for your situation after considering your eating habits ➢ A psychiatrist or psychologist: They assess and treat eating disorders ➢ And an intensive care anaesthetist: He monitors all the body functions throughout the balloon insertion and extraction...

Insertion : ^ under general anaesthetic with or without tracheal intubation ^ under endoscopic control ^ with equipment for monitoring vital and respiratory functions ^ by professionals who have received specific training After insertion : ^ you will receive advice on suitable progressive nutritional management ^you will be prescribed anti-secretory agents, anti-emetics, anti-spasmodics and/or analgesics ^ a serum electrolyte and a creatinaemia test (3rd day) will be performed ^ consultation with a member of the multi-disciplinary team every 4 to 6 weeks ^ therapeutic education programme...

INSTRUCTIONS TO BE OBSERVED AFTER INSERTION OF THE BALLOON Eat slowly in a calm atmosphere chewing the food. Reduce food intake by using small plates If you experience acid liquid reflux or bloating stop eating Fraction food into three meals and 1 snack Avoid nibbling Drink at least a liter and a half of water daily Do not drink and eat at the same time. A glass of water half an hour before a meal and one to two glasses of water half an hour after the meal are useful for the purpose of rehydrating yourself and particularly cleaning the balloon. This avoids disagreeable burping which is...

PHYSICAL ACTIVITY Restarting physical activity is very important because this enables you to stabilize weight loss. This restart should be progressive. The more weight you lose, the easier this will seem. Profit from this to increase the duration of your physical activity. The first month : progressive restarting of physical activity. As the simplest activity is walking : get off public transport one station before your destination, or park several hundred metres from your work place to start with, and then increase the distance progressively. Recommendation: Buy a pedometer in a sports...

FOOD HYGIENE RECOMMENDATION ➢ drink 1,5 l of water a day ➢ to preserve the vitamins and minerals preferably cook using steam ➢ use a list of equivalents and a table of food calorie values to vary your meals ➢ use spices and seasonings to season your preparations and avoid using salt (lemon juice, cumin, pepper, curry powder, paprika, chives, parsley, etc.) Do not miss a meal: breakfast, lunch and dinner are necessary However, you can add 1 snack in the afternoon Avoid nibbling

QUESTIONS / ANSWERS How many kg will I lose with the balloon? The balloon makes it possible to lose between 10 kg and 25 kg in 6 months if the nutritional and behavioural treatments are combined. Continuation of this treatment makes it possible to continue to lose weight after the balloon is extracted Will I regain the weight after the balloon is extracted? Continuation of the nutritional and behavioural follow-up makes it possible to avoid regaining weight after the balloon is extracted. You do not change your eating habits in 6 months. Stopping treatment after extraction exposes you to...