Outcome after laparoscopic adjustable gastric banding, using the Lap-Band and the Heliogast band: a prospective randomized study.

ABSTRACT

BACKGROUND: A study was performed to assess the usefulness and efficacy of a new type of band (Heliogast) for laparoscopic adjustable gastric banding (LAGB) for the treatment of morbid obesity, compared with the Lap-Band. METHOD: From January to May 2001, a prospective randomized study of 60 LAGB procedures was conducted group I (n=30), the Lap-Band system (INAMED); group II (n=30), the Heliogast band (Hélioscopie). We implanted the devices using the 2-step technique (pars flaccida to peri-gastric) by laparoscopy. Port systems were placed on the rectus sheath and were fixed by non-absorbable sutures. Follow-up of all patients was a minimum of 12 months. RESULTS: There were no differences in operating-time, intra-operative complications, or weight loss during the first 4 weeks after surgery. However, with increasing time, more complications with the Heliogast band and differences in weight loss favoring the Lap-Band became significant. CONCLUSION: Based on the results of this study, we recommend that new bands have independent clinical evaluation before commercialization.