Usefulness and Safeness Of Intra-Gastric Balloon Before Bariatric Surgery In Morbid Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      Introduction: bariatric surgery shows an important morbidity and there are some reports that
      have used preoperative intragastric-balloons (IGB-BIB®) to decrease surgical morbidity.

      Patients Methods: Since 2009 we are performing a randomized and prospective study to assess
      the usefulness of (IGB-BIB®) before bariatric surgery [sleeve resection (SR) or gastric
      bypass (GB)] "group A". The intervention in this group was was to place an intragastric
      Balloon for 6 months vs a control group "B" with the same type of surgical procedures but
      without preoperative IGB-BIB.The intervention on this group was only to treat the obesity
      only with diet for 6 months . All patients coming for both groups were followed at 4-week
      intervals by a nurse practitioner and dietitian for 6 months, Nurse practitioner made the
      dietetics adjustments (750-1500 Kcal) , provide advice and assess the evolution of weight
      loss The hypothesis was that preoperative IGB-BIB helps the patients to lose weight ( more
      than 10%) ,and the weight loss will contribute to decrease surgical morbidity by at least
      30%, and also will decrease hospital stay Objective: to check if morbidity, mortality and
      hospital stay decreased in the IGB-BIB ® group, and secondly if the weight before surgery was
      associated with surgical morbidity. secondary objective : Assess the rate of IGB-BIB
      failure.Intragastric balloon failure was considered when the weight loss is less than 10%
      from the initial weight. We defined severe complication whenever the patient had to be
      admitted in the hospital after discharge, new surgeries or transfusions were required or the
      hospital stay was longer than 7-10 days.
    

Detailed description: 
      Treatment with an intragastric balloon (IGB) for morbid obesity is a temporary treatment
      reached as a second step, when the initial nutritional multidisciplinary approach has failed;
      however, its value is not clear compared with other conventional medical treatments ], though
      some authors have stated that IGB achieves higher weight loss than conventional diet
      treatments (12.2% of the initial weight) ]; and others have positioned IGB as the first valid
      step in order to achieve weight loss in patients who are adequate for a future gastric bypass
      surgery. Genco et al (2009) have compared the treatment with IGB only vs. laparoscopic sleeve
      gastrectomy (LSG), and have found no differences in the amount of weight loss at 6 months,
      but a reduction in adverse events caused by IGB treatment.

      One of the potential future indications for the intragastric balloon could be its use as a
      bridge-treatment until bariatric surgery, not only in order to achieve weight loss before
      surgery, but also to select the group of patients who might benefit more from derivative
      surgery, as suggested by some authors or its use in special populations such as super-obese
      patients . The objective would be to reduce weight before the surgical procedure, in order to
      improve comorbidities, facilitate the surgical technique, and potentially reduce any surgical
      complications.

      It is increasingly frequent in many surgical units to try and achieve weigh loss before
      bariatric surgery, using intragastric balloons (IGB). However, this therapeutic approach
      currently presents dubious utility. Our study intends to contribute with our experience in
      the evaluation of IGB before surgery for achieving weight loss, and its impact on
      post-surgical morbidity.

      Bariatric surgery shows an important morbidity and there are not to many randomized
      prospective studies using intragastric- balloons (IGB-BIB®) to evaluate if getting weight
      lost really matter on decreasing surgical complications before Bariatric surgery OBJECTIVE:
      To study the usefulness of preoperative IGB-BIB® "grA" [sleeve resection (SR) or gastric
      bypass (GB)] to help decrease postsurgical complications. Secondly we try to check the rate
      of IGB-BIB® failures (a total weight loss less than 10% of the initial weight), and the
      impact on decreasing hospital stay and rate of surgical reoperations. METHODS: The study was
      a clinical prospective and randomized essay coming from 2009. Cases (grA) had an IGB during 6
      months before surgery vs Controls (grB)
    

Intervention name(s): Intragastric Balloon (IGB), group A; diet, control group B
Intervention type(s): Device; Other
Intervention description(s): the intervention was to place An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM) endoscopically under conscious sedation and was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors (PPI), and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems; the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet
Other intervention name(s): BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM; 1200 Kilocalories (Kcal) diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: morbid obesity; bioenterics intragastric balloon; bariatric surgery