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A Prospective Randomized Study of 400 Operations Performed With 2 Different Devices

Gianpiero Gravante, MD; Antonino Araco, MD; Francesco Araco, MD; Daniela Delogu; Antonino De Lorenzo, MD; Valerio Cervelli, MD

Arch Surg. 2007;142(10):958-961.

Objective  To evaluate potential differences between 2 devices used to perform laparoscopic adjustable gastric bandings (the Swedish adjustable gastric band and the Lap-Band).

Design  The following groups were considered eligible: (1) patients with a body mass index (calculated as weight in kilograms divided by height in meters squared) of greater than 40; (2) patients with a body mass index between 35 and 40, with associated comorbidities; and (3) patients with a body mass index of greater than 60 who could not undergo derivative procedures.

Results  We recruited 400 patients. The mean ± SD body mass index decreased to 40.6 ± 3.0 after the first year and to 35.2 ± 7.0 after 2 years. The average excess weight loss reduction was 48.2% after 1 year and 56.0% after 2 years. The excess weight loss reduction was inversely related to the initial weight: patients with an estimated weight excess of 50 kg or less (108 patients [27.0%]) had an excess weight loss reduction of 55% after 2 years; those with a weight excess of greater than 50 kg (292 patients [73.0%]) had an excess weight loss reduction of 44% (P =  .004). We recorded 1 death (0.2%). Transient gastric occlusions (24 patients [6.0%]) and slippages (12 patients [3.0%]) were the most common complications. The devices used (Swedish adjustable gastric band and Lap-Band) were similar in terms of correction of obesity and morbidity.

Conclusions  Laparoscopic adjustable gastric banding is a safe and feasible technique with specific indications in moderately obese patients and, secondarily, in highly obese patients who are unfit for more invasive techniques. No differences were found among the devices examined.

Trial Registration  isrctn.org Identifier: ISRCTN22839090

Author Affiliations: Departments of General Surgery (Dr Gravante) and Plastic Surgery (Dr Cervelli) and Division of Human Nutrition (Dr De Lorenzo), University of Tor Vergata, and Department of Pharmacology, University "La Sapienza" (Ms Delogu), Rome, Italy; and Department of Plastic Surgery, Dolan Park Hospital, Birmingham, England (Drs Gravante, A. Araco, and F. Araco).

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