Abstract

Indication: Initial evaluation of endoscopic gastric balloon implantation for the care of morbidly obese patients have so far shown favorable efficacy and safety profiles. The following is a case series report of this novel therapy. Methods: After patient signed informed consents, they underwent conscious sedation. A pentax endoscope was then used to place the gastric balloon (Allergen corp); each balloon was filled with 500 cc's sterile saline and 10 cc's methylene balloon. After separation of the guidance system, the balloon remained in the stomach in order to limit the amount of oral intake by reducing gastric volume. The average time for each procedure was 20 minutes. This study was carried out by the researcher in hospitals at Wilhelmshaven, Frankfurt, Cuxhaven, Remscheid, Coburg, all in Germany. Patient selection: Patients were accepted for this therapy if they had a BMI > 35 and had failed standard medical therapy employing nutrition and exercise consultations. Caloric intake and exercise were reviewed with patients prior to their enrollment. They were required to be greater than age 18 and less than 70. Study design and results: From 9/2003 to 1/2007, 30 patients underwent endoscopic gastric balloon placement (17 men and 13 women) with average age of 44 (22-66 years). The average BMI was 47 (35-81). Most balloons were removed after 6 months. To date, 23 individuals have completed the study. Seven still have their balloons. Fifteen patients had their gastric balloons in place for 6 months, one for 8 months, four for 10 months, and 2 for 13 months. One patient requested that the balloon be removed after 3 weeks. Two patients required 2 nd balloon placement. Occasional, transient nausea and vomiting did occur and these were manageable with antiemetics. No serious complications were noted. The average BMI reduction was 6 (0-11) with an average weight reduction of 19 kg (9-35 kg). Conclusion: Gastric balloon therapy for the management of morbid obesity is safe, straightforward to perform, and effective. Hopefully, this treatment can eventually be integrated into various forms of long term management based on further studies.

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