Over a 15 month period, 81 patients completed the study using the intragastric balloon. Patients were divided along BMIs in four grades: pre-obese (BMI < 30), obesity grade 1 (BMI 30-34.9), obesity grade 2 (BMI 35-39.9) and obesity grade 3 (BMI ?‰? 40). Prior to the procedure, each patient had failed to respond to previous clinical treatment for weight loss including, a calorie-restricted diet, physical activity, behavior modification and pharmacotherapy.

Researchers, led by Paula Elia, MD, at Gastroendo, performed the placement and subsequent removal of the balloon under propofol sedation. Balloons were smoothly inserted into the stomach by traction under direct endoscopy vision and were positioned in the upper stomach position. The balloon was filled with a saline solution and methylene blue, to help in locating and removal of the balloon. Patients were followed for five to seven months in a multidisciplinary clinical setting, including a gastroenterologist, endocrinologist, nutritionist, psychologist and psychiatrist. The balloon was removed after the five to seven month observation.

Participants across all obesity grades experienced significant weight loss, losing an average of 9.18 percent of initial weight. Patients with an obesity grade 3 experienced a more significant average weight loss of 12.2 percent of initial weight.

"This study reinforces the concept, efficacy and safety of intragastric balloon procedures for treatment of overweight and obesity," said Dr. Elia. "This is a reversible procedure that can be considered as an alternative weight-loss treatment option, particularly in pre-obese patients with a history of failure in other clinical treatments."

Dr. Elia cautioned that the intragastric balloon and intragastric balloon procedures are not a miracle weight loss method; after the balloon is extracted, weight loss maintenance depends exclusively on a combination of a calorie-restricted diet, physical activity and behavior modification.

Dr. Elia will present these data on Monday, May 3 at 8 a.m. CT in Hall F, Ernest N. Morial Convention Center.

Intragastric Air-Filled Balloon with New Features for Obesity (Bioflex): Preliminary Results (Abstract #W1582) A new study from the Hospital S-rio Liban-s in Sao Paolo, Brazil, suggests that a new endoscopic method using an air-filled balloon could help obese patients maintain weight loss.

Researchers led by Kiyoshi Hashiba, MD, associate professor of the surgical department at Sao Paolo University, sought to develop a balloon treatment to capture images in the stomach and small intestine using newer features to improve the safety of placement and removal of the balloon. Theirs contained a device wall with two covering sheets, one made of silicon and the other with polyurethane. It also has a valve connected to a plastic tube for inflation, along with another tube containing a needle, which is used for reinflation, deflation and retrieval.

Investigators used a Bioflex balloon (BioB), an air balloon, and inserted it with 600 ml of air over a guide wire on six patients with an average BMI of 35.8 (obese). The guide wire is necessary because unlike other balloons, it does not require manual maneuvers inside the mouth during insertion. Balloon placement and removal were conducted under general anesthesia and endotracheall intubation and removal was planned for six months, or earlier in the event of intolerance, complications or desinsuflation of the balloon.

The balloon was completely deflated at the second month in two patients for whom it had to be replaced. Investigators did not find complications in any patients such as gastric perforation, ulceration, bleeding or acid reflux. The average weight loss was a loss of BMI of minus four.

Another important feature is the connection to a tube with a needle that allows deflation easy retrieval, which permits reinflation, allowing a longer and therefore more productive scan. Since the BioB is an air balloon and the patient does not need to be an inpatient, the costs will decrease. It also allows the use of BioB for long enough to change the habits of the patient.

The study showed that BioB presents an interesting, non-invasive option for obese patients. The balloon is an aid to the obese patient to help them change their behavior, since BioB causes the initial satiety, but that eventually decreases. Satiety can be reestablished with reinflation or overinflation.

Although the treatment is not recommended for morbidly obese patients because of complications with imagery, the fact that 45 percent of obese patients are not morbidly obese means there are still many patients who could benefit from this treatment.

Dr. Hashiba will present these data on Wednesday, May 5 at 8 a.m. CT in Hall F, Ernest N. Morial Convention Center.

Source: Digestive Disease Week