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.
RCT Entities:
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.
Authors: Kian A Modanlou; Umadevi Muthyala; Huiling Xiao; Mark A Schnitzler; Paolo R Salvalaggio; Daniel C Brennan; Kevin C Abbott; Ralph J Graff; Krista L Lentine Journal: Transplantation Date: 2009-04-27 Impact factor: 4.939
Authors: S Sauerland; L Angrisani; M Belachew; J M Chevallier; F Favretti; N Finer; A Fingerhut; M Garcia Caballero; J A Guisado Macias; R Mittermair; M Morino; S Msika; F Rubino; R Tacchino; R Weiner; E A M Neugebauer Journal: Surg Endosc Date: 2004-12-02 Impact factor: 4.584