The safety and efficacy of the procedureless intragastric balloon.

BACKGROUND

Obesity is on a continuous rise worldwide, and with it, novel bariatric procedures have emerged. The introduction of gastric balloons has opened up a nonsurgical option for patients opting for it. However, they still require some form of sedation and endoscopy for insertion and/or removal.

OBJECTIVES

The Elipse balloon is a novel creation that has managed to bypass both these procedures; therefore, the investigation into its effectiveness is of importance.

SETTING

Royale Hayat, Sabah, and Amiri Hospitals, Kuwait.

METHODS

This is a multicenter, prospective analysis of all patients who underwent the Elipse balloon insertion. For the duration of 4 months, weight, body mass index, and the occurrence of adverse events was documented.

RESULTS

A total of 135 patients were included, with a mean age of 33.5 years. At the 4-month mark, the mean weight of the patients showed a drop of 13.0 kg (P = .000), and the mean body mass index showed a drop of 4.9 units (P = .000). The mean percent total weight loss was 15.1%. All patients reported nausea in the first day of insertion; however, 69.6% reported complete resolution by the third day. Two patients (1.5%) vomited the balloon early, 3 patients (2.2%) had to have the balloon removed early due to intolerance, 3 patients (2.2%) experienced early deflation, 18 (13.3%) patients reported episodes of diarrhea around the time of deflation, and 29 (21.5%) patients experienced colicky abdominal pain in the week of balloon deflation. One patient experienced small bowel obstruction after which the balloon was removed via laparoscopic enterotomy.

CONCLUSION

This study aimed to evaluate the safety and effectiveness of the Elipse balloon in the largest population studied as of date. It was also able to demonstrate that it can be safely and successfully swallowed, filled, imaged, and passed. In addition, it effectively aided in weight loss, showing promising results.