Adjustable gastric banding outcomes with and without gastrogastric imbrication sutures: a randomized controlled trial.

BACKGROUND: The intended purpose of gastrogastric imbrication sutures in laparoscopic adjustable gastric banding is to reduce band-related complications; however, evidence demonstrating imbrication suture utility has been lacking. A 3-year randomized controlled trial on the safety and efficacy of laparoscopic adjustable gastric banding with and without imbrication sutures was undertaken. We performed a prospective investigation of the outcomes using the Swedish adjustable gastric band (SAGB) with and without imbrication sutures.
METHODS: From January to September 2006, 100 patients undergoing SAGB placement were randomized to group 1 (n = 50, ≥ 2 imbrication sutures) or group 2 (n = 50, no imbrication sutures). The SAGB was implanted in both groups using a standardized pars flaccida technique. The mean operative time, hospitalization time, percentage of excess weight loss, body mass index, band fill volume, and complications were recorded. The Fisher exact test for categorical data, the independent samples t test for continuous data, and the paired t test to assess the body mass index reduction were performed. All tests were 2-tailed, and statistical significance was set at P <.05.
RESULTS: The mean operative time was 75 ± 7 minutes (range 50-92) and 48 ± 4 minutes (range 32-75) for groups 1 and 2, respectively (P <.001). The mean hospitalization time was 26 ± 12 hours (range 20-96) and 23 ± 9 hours (range 20-48) for groups 1 and 2, respectively (P <.17). The 3-year percentage of excess weight loss was 55.7% ± 3.4% and 58.1% ± 4.1% for groups 1 and 2, respectively (95% confidence interval -4.0% to -.8%, P <.01). The body mass index at 3 years was 34.0 ± 5.8 kg/m(2) and 30.3 ± 6.4 kg/m(2) (range 1.2-6.2) for groups 1 and 2, respectively (P <.01). The fill volume at 3 years was 3.6 ± 1.2 mL (range 1.0-5.5) and 4.5 ± 0.5 mL (range .0-5.0) for groups 1 and 2, respectively (P <.01). Finally, slippage occurred in 1 patient (2.2%) and 1 patient (2.0%) and migration in 1 patient (2.2%) and 1 patient (2.0%) in groups 1 and 2, respectively (P = NS). No patient died in either group.
CONCLUSION: The results of our randomized controlled trial have demonstrated that SAGB combined with a conservative approach to band adjustments and limited retrogastric dissection is effective and safe with and without imbrication sutures. Not using imbrication sutures results in significant benefits in operative speed with comparable clinical weight loss and intermediate term safety. These randomized controlled trial data suggest that imbrication sutures are not indispensable to laparoscopic adjustable gastric banding and their use can be left to the surgeon's discretion. Copyright Â

RCT Entities:   Population Interventions Outcomes