Recommendations

Before the procedure

  • Treatment of patients with a view to inserting a balloon must be global.  It must take place within multidisciplinary teams, liaising with the attending physician.  These teams will include as a minimum a gastroenterologist, a doctor specializing in obesity (nutritionist, endocrinologist or specialist in internal medicine), a dietician, a psychiatrist or psychologist and an intensive care anesthesiologist.  These teams can take the advice of other health professionals as required (surgeon, endocrinologist specializing in diabetes, radiologist, cardiologist, doctor specializing in lung disease, rheumatologist, rehabilitation doctor, dentist, physiotherapist, etc.)
  • The patient must be informed of the advantages and disadvantages of the balloon (including failure rates, and complications), the obligation to remove the balloon after 6 months, the necessity of multidisciplinary treatment and long-term follow-up.
  • Patients must be advised on contraception
  • The decision to insert the balloon must be taken after discussion and consultation with the multidisciplinary team
  • Before the procedure routine pregnancy testing using a plasma b-HCG assay should be performed for women of childbearing age
  • Testing for and treatment of a Helicobacter pylori infection is not routine but left to the discretion of the operator.

During the implementation of the procedure

- Cleaning: No cleaning is necessary. In no circumstances must the product be sterilized as no procedures have been validated for the product. Do not soak the product in disinfectant.  The material may absorb some of the solution and cause a tissue reaction.

- Anesthesia: An anesthesiologist will be solely responsible. The balloon must be inserted under general anesthesiologist with or without tracheal intubation, under endoscopic control in the endoscopy room with equipment for monitoring vital functions and a respirator, by professionals who have received specific training in a referral center already practicing these procedures.

  • Insertion:
    • General anesthesia using Propofol, a short-term anesthetic drug  (e.g. Diprivan or a generic)
    • Spontaneous ventilation
    • Duration: ~15 minutes
  • Extraction:
    • General anesthesia using Propofol, a short-term anesthetic drug  (e.g. Diprivan or a generic)
    • Patient intubated and ventilated
    • Duration: ~15 minutes

- Insertion: The intra-gastric balloon system END can be used on an endoscope

A control endoscopy is recommended to check:
  • The integrity of the esophagus, cardia and stomach.
  • Photographs of all these anatomical parts should be taken and placed in the patient's file.

After the procedure

  • A control endoscopy is recommended to check the correct inflation of the balloon (bag under tension, smooth appearance, etc.) and the correct positioning and freedom of movement of the balloon in the gastric antrum
  • A progressive re-feeding protocol will be prescribed
  • A blood ionogram and creatinemia are advised at about the 3rd day
  • A consultation with a member of the multidisciplinary team is recommended every 4 to 6 weeks
  • Prescription of medicines: This is the responsibility of the practitioner.

Short term (the first 8 days)
  • Anti-nausea drugs such as metoclopramide, either long-acting or to be taken twice daily
  • As required, digestive anti-spasmodic such as tiemonium methyl sulphate 50mg.

Long term (during the 6 months)
  • Proton pump inhibitor (PPI) gastric anti-secretory agent, full dose taken daily (e.g. Lansoprazole 30mg/d)

Important: Do not prescribe food supplements or their equivalent containing enzymes of biological origin.

Restriction of activity: It is strictly forbidden for the patient to dive or to fly in an unpressurised aircraft (if the balloon is filled with air).  Combat and extreme sports are definitely not recommended.


Instructions for use