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Risks and benefits

Trio of studies underlines sleeve gastrectomy safety

16,000 patients in the BOLD study had LSG; over 99% had no serious complications
Figures place LSG between gastric bypass and gastric banding for safety and efficacy
BOLD database reveals <1% serious complication rate for LSG
ASMBS push for sleeve gastrectomy to become primary procedure in USA

Three new studies have shown that laparoscopic sleeve gastrectomy offers comparable safety to gastric bypass and gastric banding. The new research was presented at the ASMBS’ 29th Annual Meeting in San Diego.

In one study, Stanford University researchers analysed safety data from the BOLD database, including nearly 270,000 metabolic and bariatric surgeries performed between 2007 and 2010.

Almost 6% (nearly 16,000) of the surgeries were sleeve gastrectomies, which had a 30-day serious complication rate of 0.96%, compared to 1.25% for gastric bypass and 0.25% for gastric banding.

The 30-day mortality rate for sleeve gastrectomy was 0.08%, compared to 0.14% for gastric bypass and 0.03% for gastric banding. The ASMBS pointed out that this is lower than is typically associated with gallbladder or hip replacement surgery.

Patients in the study saw their BMI drop by an average of 30% after one year (47.5 to 34.1) after sleeve gastrectomy, compared to 40% for gastric bypass and 20% for gastric bands.

“In terms of risk and benefit, sleeve gastrectomy sits nicely between gastric bypass and adjustable gastric band,” said lead study author John Morton, MD, associate professor of surgery and director of bariatric surgery at Stanford Hospital & Clinics at Stanford University.

Proof of safety

This data, along with several other large studies published within the last two years, was recently submitted to the Centers for Medicare & Medicaid Services (CMS), as the agency considers a new national coverage determination for laparoscopic sleeve gastrectomy for its beneficiaries.

The CMS recently proposed coverage for sleeve gastrectomy only as part of a randomised control trial, ruling that currently available evidence is insufficient to support its widespread adoption.

The ASMBS disagree, and are keen for sleeve gastrectomy to be more widely adopted in America.

“Sleeve gastrectomy has proven itself to be a safe and effective option in patients with morbid obesity and this procedure should be considered a primary procedure for weight loss and obesity-related disease improvement and resolution,” said Dr Robin Blackstone, president of the ASMBS.

In a further study, researchers from Cleveland Clinic Florida reviewed safety outcomes of more than 2,400 of their patients who had sleeve gastrectomy, gastric bypass or bariatric and metabolic surgery between 2005 and 2011.

The study found sleeve gastrectomy had the lowest complication and reoperation rates of the three procedures.

1.5% of sleeve gastrectomies in the study required reoperation due to complications. This is much lower than for gastric band and gastric bypass, which resulted in 15.3% and 7.7% requiring reoperation respectively.

On average, patients had a BMI between 44 and 48, were 46 years of age and had at least two comorbidities.

A third study comparing sleeve gastrectomy with gastric bypass conducted by the Naval Medical Center in San Diego found while bypass patients lost more of their excess weight after the first year (72.3% versus 63.7%), there were no statistically significant differences in excess weight loss after two and five years.

This study examined 486 patients. Half had gastric bypass and half had sleeve gastrectomy.

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American Society for Metabolic and Bariatric Surgery

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