Is fixation during gastric banding necessary? A randomised clinical study.

Anterior fixation via a gastro-gastric suture in laparoscopic adjustable gastric banding (LAGB) is commonly performed to prevent band-related complications. However, the necessity of this common technique has never been proven. Not fixing the band would be time sparing and would reduce adhesions on the stomach and probably make revisional surgery easier. This study was conceived as a 3-year randomised clinical trial to test the safety and efficacy of the non-fixation technique. From December 2006 to December 2007, 81 patients undergoing LAGB were randomly distributed into two groups: group A, with gastro-gastric sutures (n = 41) and group B, without gastro-gastric fixation (n = 40). The two groups were equivalent regarding initial body mass index (BMI), age and sex ratio. The main outcome was postoperative complications and secondary outcomes were operative time and weight loss expressed by the percentage of excess BMI loss (%EBMIL). All patients were prospectively followed up for 2 years. The mean preoperative BMI was 42.5 kg/m² (35-56). All patients were available for follow-up at 2 years. The mean overall preoperative time was 82 ± 20 min for the fixation group and 72 ± 20 min for the non-fixation group (p = 0.13). The mean hospital stay was 4.1 ± 1.5 days (no significant difference between the two groups). The 2-year %EBMIL was 35.9 for group A and 39.4 for group B (p = NS). The mean BMI at 2 years was 36.3 and 36.1, respectively, with no statistical difference. We observed three early band slippages in the non-fixation group and none in the fixation group. Three bands were removed during the second year of follow-up for causes other than band slippage (no significant difference between the two groups). This study was interrupted before a statistical significance could be reached, under the general agreement of all participating surgeons, because of the three unexpected early band slippages. For the patients who did not suffer from this complication, we did not observe any differences between the two groups in terms of late complications and weight loss. The operative time was shorter in the non-fixation group. This randomised clinical trial suggests that care should be taken when not fixating the LAGB because of the risk of early postoperative band slippage. We suggest that fixing the LAGB by gastro-gastric sutures should remain common practice.

RCT Entities:   Population Interventions Outcomes