Let’s Get Real: Defining Our Future

Column Editor: Walter J. Pories, MD, FACS

Dr. Pories is professor of surgery at the Brody School of Medicine, East Carolina University, Greenville, North Carolina. Dr. Chapman is professor of surgery at the Brody School of Medicine, East Carolina University, Greenville, North Carolina.

This month: Defining Our Future. by Walter J. Pories, MD, FACS, and William H. H. Chapman, III, MD, FACS

Bariatric Times. 2013;10(8):8–9.

Funding: No funding was provided in the preparation of this manuscript.

Financial disclosures: Dr. Pories reports no conflicts of interest relevant to the content of this column.

An original cartoon by Dr. Pories

We are constantly defending bariatric surgery. We should not have to. It is, by far, the most effective treatment for diabetes and obesity. As documented in the two prospective randomized trials by Schauer[1] and also by Mingrone[2], nothing else even comes close.

The problem is that our discipline lacks credibility. Our reported results differ too widely to be believable. We report even weight loss in a confusing set of metrics, citing changes in kilograms, pounds, percent weight loss (%WL), percent excess weight loss (%EWL), body mass index (BMI), waist circumference, sagittal diameter, and reduction in body fat. To add to the confusion, duration and completeness of follow up vary widely. For example, note the differences in the following reports: Kahayan et al[3] reported a randomized trial of Roux-en-Y gastric bypass (RYGB) versus intensive medical treatment in terms of reduction in body fat(-16 vs. -10%; P=0.04). Admiraal et al[4] compared the effects of the RYGB in different ethnic groups in terms of %EWL>50% at one year (Dutch 73.7%, African 64.6%, Moroccan 48.1%). How can our colleagues assess these reports?

In terms of resolution of diabetes, the published data are equally confusing. Results are reported in terms of fasting blood sugar (FBS), Hb1ac, oral glucose tolerance tests, and intravenous (IV) glucose tolerance tests, but few, if any, document the changes that really count, such as remission of retinal damage, avoidance of amputations, and reversal of neuropathies. Further, there is the disagreement whether Hb1Ac values of 7.0, 6.5, or 6.0 should be the goal. Ikkramudin[5] even chose to bypass these conflicts by defining the superiority of bariatric surgery in terms of the reduction in numbers of medications (the surgical group required 3.0 fewer medications; mean, 1.7 vs. 4.8; 95% confidence interval [CI] for the difference, 2.3–3.6.)

In addition to the failure to agree on outcome measures, we do not deliver a defined and uniform product. When we note that a patient has had RYGB, we really describe a group of operations, not a single procedure. The operations, known by a single name, can vary by the following: 1) the size of the pouch; 2) size of the gastroenterostomy; 3) construction of the gastroenterostomy—circular, linear staplers, or hand sewn; 4) length of the alimentary limb; 5) length of the biliopancreatic limb; 5) retrocolic vs. antecolic construction; 6) closure of potential internal hernia sites; 7) open vs. laparoscopic approaches; 8) use of a constricting band; 9) use of drains; 10) routine repair of diaphragmatic crura; and 11) routine cholecystectomy. If you do the math, it is possible to have over 1,000 variations of the gastric bypass. In addition, there are variations in the preoperative preparation, such as the use of low-calorie liquid diets to shrink the liver, differences in anesthesia, and modifications of postoperative diets.

Given this confusion and the erroneous imagined high risks of surgery, it is not surprising that our colleagues, carriers, and patients have doubts; doubts so severe that less than one percent of those who could benefit from it undergo the surgery. Yes, less than one percent!

For bariatric surgery to succeed and to overcome the resistance of colleagues and carriers, we need to address these concerns. The first, (i.e., agreement on uniform metrics and goals) should not be difficult to address. Instead of waiting for the American Diabetes Society or other groups to set these goals, the American Society for Metabolic and Bariatric Surgery (ASMBS) and/or International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) could consider the following guidelines: 1) weight loss should be measured in %WL (in addition to changes in kg and BMI); 2) type 2 diabetes (T2D) can be considered in “full remission” when the Hb1Ac is 6.5 without any antidiabetic medications for two years after surgery; and 3) T2D can be considered “cured” with the same metrics at five years.

In addition, our professional organizations could recommend that 1) published reports should include follow-ups of at least 12 months, preferably 24 months, for the entire cohort unless the objective of the report is to publish a bad outcome to warn others to avoid the tested approach; 2) follow-up rates should be reported in terms of months, extent, and percentage of follow-up; and 3) re-emphasize that investigational operations should continue to be published but only if conducted under the supervision of an Institutional Review Board.

Standardizing a single form of the RYGB is and probably should be impossible, but there are two steps that we could take promptly to describe the operation with greater accuracy and to learn which form provides the best outcomes. The first is to adopt a code similar to the AAAA code (Approach, Anatomy, Anastomosis, Alimentary) suggested in Table 1. Thus, a laparoscopic antecolic RYGB with an EEA of 21mm and an alimentary limb length of 150cm could be coded as “AAE1N.” To keep the code simple, it assumes that all distal enteroenterostomies are side to side and the biliopancreatic limb is 30 to 75cm from the ligament of Treitz. Second, since most experienced surgeons with large series, such as Drs. Courcoulas, Higa, Ikkramudin, Rosenthal, Schauer, and Wittgrove, generally stick to one procedure, we could begin by comparing outcomes and identifying steps in the RYGB that are more critical than others in obtaining optimum results.

If we maintain that metabolic surgery is superior to pharmaceutical interventions, at the least, we need to deliver our product with the same clearly defined standards expected of industry.

References
1.     Schauer PR, Kashyap SR,     Wolski K, Brethauer SA, et al. Bariatric surgery versus intensive medical therapy in obese patients with diabetes. N Engl J Med. 2012; 26;366(17):1567–1576.
2.    Mingrone G, Panunzi S, De Gaetano A, Guidone C, et al. Bariatric surgery versus conventional medical therapy for type 2 diabetes.N Engl J Med. 2012 Apr 26;366(17):1577–1585.
3.    Kashyap SR, Bhatt DL, Wolski K, Watanabe RM, et al. Metabolic effects of bariatric surgery in patients with moderate obesity and type 2 diabetes: analysis of a randomized control trial comparing surgery with intensive medical treatment. Diabetes Care. 2013 Feb 25.
4.    Admiraal WM, Bouter K, Celik F, Gerdes VE, Klaassen RA, et al. Ethnicity Influences Weight loss 1 year after bariatric surgery: a study in Turkish, Moroccan, South Asian, African and Ethnic Dutch patients. Obes Surg. 2013 Jul 3.
5.     Ikramuddin S, Korner J, Lee WJ, Connett JE, et al. Roux-en-Y gastric bypass vs intensive medical management for the control of type 2 diabetes, hypertension, and hyperlipidemia: The Diabetes Surgery Study randomized.

Category: Let's Get Real, Past Articles