Criteria for Inclusion of Newer Bariatric and Metabolic Procedures into the Mainstream: a Survey of 396 Bariatric Surgeons.

BACKGROUND

There is currently no consensus on the criteria for inclusion of new bariatric procedures into routine clinical practice. This study canvasses bariatric surgeons in an attempt to define these criteria.

METHODS

Bariatric Surgeons from around the world were invited to participate in a questionnaire-based survey on SurveyMonkey ®.

RESULTS

396 bariatric surgeons, 337 International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) members, took the survey. Five clinical studies conducted under the strict monitoring of an Institutional Review Board would satisfy most surgeons (67.7 %, n = 266). When asked regarding the number of patients in these studies, a cumulative number of 500 patients would satisfy 64.5 % (n = 255) of the surgeons. Most respondents regarded endorsement by their national society and IFSO as 'very important' or 'extremely important'. An overwhelming 74.4 % (n = 294) felt that every new procedure should undergo a randomized comparison against one of the established alternatives like Roux-en-Y Gastric Bypass or Sleeve Gastrectomy.

CONCLUSION

Evaluation of a new bariatric procedure in at least 5 adequately supervised clinical studies (four of which must be randomized comparisons with one of the existing alternatives) reporting at least 5 years results on a minimum of 500 patients would satisfy majority of bariatric surgeons for the inclusion of a new bariatric procedure into clinical practice. The findings of this survey are simply aimed at starting a discussion on this topic and cannot be used to influence the ground reality until an international consensus can be reached amongst experts.