Kamal K Mahawar1, Cynthia-Michelle Borg2, Sanjay Agarwal3, Rui Riebeiro4, Maurizio De Luca5, Peter K Small6. 1. Bariatric Unit, Sunderland Royal Hospital, Sunderland, SR4 7TP, UK. kamal_mahawar@hotmail.com. 2. Lewisham and Greenwich NHS Trust, University Hospital Lewisham, London, UK. 3. Homerton University Hospital, London, UK. 4. Centro Hospitalar de Lisboa Central, Unidade de Tratamento Cirúrgico da Obesidade e Doenças Endoórinas, Lisbon, Portugal. 5. Obesity Unit, Montebelluna Treviso Hospital, Veneto, Italy. 6. Bariatric Unit, Sunderland Royal Hospital, Sunderland, SR4 7TP, UK.
Abstract
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.
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.
Entities:
Keywords:
Bariatric surgery; Experimental procedures; Mini gastric bypass; New procedures; Obesity surgery; One anastomosis gastric bypass
Authors: Kamal K Mahawar; Cynthia-Michelle Borg; Kuldeepak Singh Kular; Michael J Courtney; Karim Sillah; William R J Carr; Neil Jennings; Brijesh Madhok; Rishi Singhal; Peter K Small Journal: Obes Surg Date: 2017-09 Impact factor: 4.129