A study comparing LAP-BAND patients to RNY gastric patients was recently reported in the news media because the conclusion of the authors (Campos et al) was that the rates of complications were similar between bypass and LAP-BAND, however, outcomes were better in the gastric bypass group. This study came out shortly after the FDA approved the LAP-BAND for lower BMI patients based on a study by the Low BMI study Group.

Careful review of the data reveals deficiencies in the RNY group’s reporting mechanisms. Comparing the two studies shows that having a LAP-BAND is not only safe, but is best done in high volume centers.

Operating Time: Average operating room time for the LAP-BAND in the Campos group was 145 minutes. Contrast that with the Low BMI study group average operating room time of 41 minutes. The Low BMI study group had surgeons who were highly experienced in performing LAP-BAND procedures, and this is reflected in the operating room time. The Campos group, spending over 100 additional minutes leads to the conclusion that they are not a high volume center. This conclusion is supported by the fact that it took Campos over three years to enroll enough patients.

Complications: No surgery is free of complications – but the complication rate from the Campos group is higher than normal (re operation rate of 13%). Contrast that with the Low BMI study group that had a re-operation rate of 4.7%. Again, the Low BMI study group consisted of surgeons with substantially more experience than the Campos group.

Weight Loss: The Campos group reported a 36% excess weight loss at one year for the LAP BAND and 64% for the RNY. This is in contrast to the Low BMI Study group who had 64.5% at the first year (which is equal to what the Campos group reported for the RNY gastric bypass). Two-year data was not available in the Campos group, but the Low BMI study group showed excess weight loss of 70.4%

Follow-Up Visits: The LAP-BAND works through appetite suppression. If there is no suppression of appetite the patient will not lose weight. This requires patients with the LAP-BAND undergo periodic adjustments to the band, particularly in the first year. The Campos protocol was to give two to three adjustments to the LAP-BAND in the year. The published standard is clear: patients who have a LAP-BAND need an average of six adjustments, not three. The Low BMI study group did an average of 6.2 adjustments in the first year – which no doubt accounts for the superior weight loss.

Quality of Life: The Campos Quality of Life indicators were not statistically significant. However, Quality of Life indicators for those receiving the LAP-BAND from our group are substantially higher than their group.

Conclusion: The LAP-BAND is not a simple operation, nor is the aftercare simple. However, high volume practices provide superior results with fewer complications than low volume centers, such as the Campos groups. Conclusions about the efficacy of the band should not be made based on small studies of surgical groups that do low volumes. The LAP-BAND procedure done in high volume centers provides superior outcomes in terms of less operating room time, fewer re operations, fewer complications, more adjustments, and more weight loss.

References: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/Gastroenterology-UrologyDevicesPanel/ucm234224.htm

Campos, Rabl, et. Al. Better Weight Loss, Resolution of Diabetes, and Quality of Life for Laparoscopic Gastric Bypass vs Banding. Arch Surg. Feb 2011

Terry Simpson, MD FACS – is a bariatric surgeon in Phoenix Arizona, and a member of the Low BMI Study Group.

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