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Long-term data

Surgery effective, more long-term data needed

Workshop was arranged to summarise the current knowledge concerning bariatric surgery and establish priorities for future research directions.
There are still unclear are predictors of outcomes, long-term complications and long-term survival

More information is needed about the long-term durability of comorbidity control and complications after bariatric procedures, those are the conclusions from a paper 'Long-term Risks and Benefits of Bariatric Surgery: A National Institutes of Health Symposium', published in JAMA Surgery. The paper is the result of a multidisciplinary workshop convened in May 2013 by the National Institute of Diabetes and Digestive and Kidney Diseases and the National Heart, Lung, and Blood Institute.

The conclusions from the Workshop also noted that “bariatric surgical procedures result in greater weight loss than non-surgical treatments and are more effective at inducing initial type 2 diabetes mellitus remission in obese patients".

The Workshop was arranged to summarise the current knowledge concerning bariatric surgery, review research findings on the long-term outcomes of bariatric surgery, and establish priorities for future research directions. The workshop planning committee selected papers based on the quality and duration of follow-up, and the placed a greater emphasis on randomised clinical trials and large observational studies with long-term follow-up (with or without a control group).

The panel reported that several small clinical trials showed that in the first two years post-surgery, bariatric patients had greater weight loss and type 2 diabetes mellitus remission compared against non-surgical treatments. In addition, they also found that larger, long-term (>5 years) observational studies have shown durable weight loss, diabetes, and lipid improvements after bariatric surgery.

Nevertheless, the panel warned that “there are still unclear are predictors of outcomes, long-term complications, long-term survival, microvascular and macrovascular events, mental health outcomes, and costs,” and added that designing and carrying out such studies would be expensive.

“More information is needed about the long-term durability of comorbidity control and complications after bariatric procedures and this evidence will most likely come from carefully designed observational studies,” the paper concludes.

Research

In an additional paper published in the same issue of JAMA Surgery, Drs Bruce Wolfe and Steven Belle discuss the current and future research challenges facing bariatric and metabolic surgery.

The authors argue that although RCTs could potentially provide much needed data, the heterogeneity of patients and the relative homogeneity of surgical procedures would require very large numbers of patients, and the costs associated with such large scale RCTs is unaffordable.

They endorse the views of the workshop panel that large, well-designed, long-term observational studies could identify and study long-term outcomes, however, they also caution that such studies can result in poor follow-up and lack consistency, potentially undermining the research.

In addition to research models, they authors also note future research should identify:

  • those patients who are more likely to be ‘successful’ candidates for surgery
  • the true incidence of long-term complications to establish the risk-to-benefit ratio of surgical procedures

“No single study or research model will successfully address all of these questions,” they conclude. “The substantial resources required for a clinical trial large enough with enough follow-up to address important research questions may be impractical, so extending follow-up of well-characterized and established cohorts, potentially with linkage to other data resources, may be the best hope to obtain the information needed to address long-term risks and benefits of bariatric surgery.”

To access the article by Drs Wolfe and Belle, please click here

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