The First Consensus Statement on One Anastomosis/Mini Gastric Bypass (OAGB/MGB) Using a Modified Delphi Approach.

BACKGROUND: An increasing number of surgeons worldwide are now performing one anastomosis/mini gastric bypass (OAGB/MGB). Lack of a published consensus amongst experts may be hindering progress and affecting outcomes. This paper reports results from the first modified Delphi consensus building exercise on this procedure. METHODS: A committee of 16 recognised opinion-makers in bariatric surgery with special interest in OAGB/MGB was constituted. The committee invited 101 OAGB/MGB experts from 39 countries to vote on 55 statements in areas of controversy or variation associated with this procedure. An agreement amongst ≥ 70.0% of the experts was considered to indicate a consensus. RESULTS: A consensus was achieved for 48 of the 55 proposed statements after two rounds of voting. There was no consensus for seven statements. Remarkably, 100.0% of the experts felt that OAGB/MGB was an "acceptable mainstream surgical option" and 96.0% felt that it could no longer be regarded as a new or experimental procedure. Approximately 96.0 and 91.0% of the experts felt that OAGB/MGB did not increase the risk of gastric and oesophageal cancers, respectively. Approximately 94.0% of the experts felt that the construction of the gastric pouch should start in the horizontal portion of the lesser curvature. There was a consensus of 82, 84, and 85% for routinely supplementing iron, vitamin B12, and vitamin D, respectively. CONCLUSION: OAGB/MGB experts achieved consensus on a number of aspects concerning this procedure but several areas of disagreements persist emphasising the need for more studies in the future.

Two-Year Outcomes of Vagal Nerve Blocking (vBloc) for the Treatment of Obesity in the ReCharge Trial.

BACKGROUND: The ReCharge Trial demonstrated that a vagal blocking device (vBloc) is a safe and effective treatment for moderate to severe obesity. This report summarizes 24-month outcomes. METHODS: Participants with body mass index (BMI) 40 to 45 kg/m2, or 35 to 40 kg/m2 with at least one comorbid condition were randomized to either vBloc therapy or sham intervention for 12 months. After 12 months, participants randomized to vBloc continued open-label vBloc therapy and are the focus of this report. Weight loss, adverse events, comorbid risk factors, and quality of life (QOL) will be assessed for 5 years. RESULTS: At 24 months, 123 (76 %) vBloc participants remained in the trial. Participants who presented at 24 months (n = 103) had a mean excess weight loss (EWL) of 21 % (8 % total weight loss [TWL]); 58 % of participants had ≥5 % TWL and 34 % had ≥10 % TWL. Among the subset of participants with abnormal preoperative values, significant improvements were observed in mean LDL (-16 mg/dL) and HDL cholesterol (+4 mg/dL), triglycerides (-46 mg/dL), HbA1c (-0.3 %), and systolic (-11 mmHg) and diastolic blood pressures (-10 mmHg). QOL measures were significantly improved. Heartburn/dyspepsia and implant site pain were the most frequently reported adverse events. The primary related serious adverse event rate was 4.3 %. CONCLUSIONS: vBloc therapy continues to result in medically meaningful weight loss with a favorable safety profile through 2 years. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT01327976.

Recalcitrant hypocalcemia after thyroidectomy in patients with previous Roux-en-Y gastric bypass.

BACKGROUND: Hypocalcemia is a potential complication after thyroidectomy. Patients with previous roux-en-Y gastric bypass (RYGBP) may be at increased risk for recalcitrant symptomatic hypocalcemia after thyroidectomy. This complication is poorly described and there is no current consensus on optimal management in this unique population. METHODS: All patients from 2000 to 2012 who underwent thyroidectomy with history of preceding RYGBP were identified retrospectively. Each of the 19 patients meeting inclusion criteria were matched 2:1 for age, gender, and body mass index (BMI) to a cohort who underwent thyroidectomy without previous RYGBP. The study cohort and matched controls were compared for incidence of symptomatic postoperative hypocalcemia, requirement of intravenous (IV) calcium supplementation, and duration of hospital stay. RESULTS: Age, proportion of female patients, and BMI were equivalent between cases (n = 19) and controls (n = 38). Comparison of primary outcomes demonstrated that the study group had a significantly higher incidence of symptomatic hypocalcemia (42% vs. 0%; P < .01), administration of IV calcium (21% vs. 0%; P < .01), and duration of hospital stay (2.2 vs. 1.2 days, P = .02). CONCLUSION: Patients with previous RYGBP have a greater incidence of recalcitrant symptomatic hypocalcemia after thyroidectomy, resulting in prolonged duration of hospital stay. In this patient population, calcium levels should be closely monitored and early calcium and vitamin D supplementation initiated preemptively.

Compilation of recommendations from summit on increasing physician nutrition experts.

This report compiles the list of recommendations derived from the Summit on Increasing Physician Nutrition Experts. The recommendations represent expert opinion on topics related to increasing the number of physicians who choose nutrition as a career option and on topics related to strengthening multidisciplinary educational programs, research activity, and clinical practice in nutrition in the future. The recommendations should not be interpreted to represent consensus, approval, or endorsement by attendees or participating societies. A simple prioritization scheme identifies those short-term recommendations that should be more feasible, receive more immediate attention, and possibly require fewer resources than those described as long-term. Many of these recommendations are already being acted upon by various groups within the participating societies. The listing of recommendations does not imply responsibility for implementation by Summit attendees. The role for any council arising from this Summit is yet to be defined but may certainly involve facilitating communication and collaboration of initiatives arising from many of the issues listed here.

Creation of nutrition support centers of excellence: is it truly an excellent idea?

In response to external pressures and events that threatened to adversely affect the field of bariatric surgery, the American Society for Metabolic and Bariatric Surgery created a mechanism for certifying surgeons and their facilities to guarantee that bariatric surgery would be performed with the greatest degree of patient safety. Those surgeons and facilities that satisfied the requirements were designated as Bariatric Surgery Centers of Excellence (BSCOE). That process involved creating an independent, not-for-profit corporation, establishing the best practice criteria for certification, and developing the mechanism for evaluating surgeons and programs. After the successful implementation of this program, the American College of Surgeons introduced a similar program, Bariatric Surgery Center Network. It was believed that implementing a BSCOE program in the field of bariatric surgery would counteract the forces threatening to reduce patient access to surgery. Although some of the predicted benefits have been realized, many have not. Additionally, the process has been shown to be costly in terms of labor and monetary expense. The field of nutrition support has many similarities to bariatric surgery. Although no acute crisis threatens to adversely affect the field, leaders are considering the creation of a similar credentialing program. The decision to proceed with the development of a Nutrition Support Center of Excellence should be made after significant discussion centered on the potential benefits and problems related to such a program. The BSCOE process can be used as a successful model. This article reviews the issues leading up to the creation of the BSCOE, describes its certification process, mentions some of the benefits, and offers recommendations for the consideration of an NSCOE program.

Implantable gastric stimulation for the treatment of clinically severe obesity: results of the SHAPE trial.

BACKGROUND: To compare implantable gastric stimulation therapy with a standard diet and behavioral therapy regimen in a group of carefully selected class 2 and 3 obese subjects by evaluating the difference in the percentage of excess weight loss (EWL) between the control and treatment groups. The primary endpoint was the percentage of EWL from baseline to 12 months after randomization. Implantable gastric stimulation has been proposed as a first-line treatment for severely obese patients; however, previous investigations have reported inconclusive results. METHODS: A total of 190 subjects were enrolled in this prospective, randomized, placebo-controlled, double-blind, multicenter study. All patients underwent implantation with the implantable gastric stimulator and were randomized to 1 of 2 treatment groups: the control group (stimulation off) or treatment group (stimulation on). The patients were evaluated on a monthly basis. All individuals who enrolled in this study agreed to consume a diet with a 500-kcal/d deficit and to participate in monthly support group meetings. RESULTS: The procedure resulted in no deaths and a low complication rate. The primary endpoint of a difference in weight loss between the treatment and control groups was not met. The control group lost 11.7% +/- 16.9% of excess weight and the treatment group lost 11.8% +/- 17.6% (P = .717) according to an intent-to-treat analysis. CONCLUSION: Implantable gastric stimulation as a surgical option for the treatment of morbid obesity is a less complex procedure than current bariatric operations. However, the results of the present study do not support its application. Additional research is indicated to understand the physiology and potential benefits of this therapy.

Severe obesity: a growing health concern A.S.P.E.N. should not ignore.

The definition of malnutrition in the published standards of the American Society of Parenteral and Enteral Nutrition (A.S.P.E.N.) is any derangement in the normal nutrition status and includes overnutrition, commonly referred to as obesity. The incidence of obesity is increasing and reaching epidemic proportions in the United States and even worldwide. This has significant financial impact as our society spends billions of dollars on fad diets, commercial weight-loss programs, nutrition and dietary supplements, prescription and over-the-counter medications, and health clubs. Another approximately dollars 100 billion are spent to treat the medical consequences of obesity. Currently, for those patients with intractable morbid obesity, defined as having a body mass index >40 kg/m2, surgery offers the only option for achieving meaningful and sustainable weight loss. The resultant weight loss dramatically improves health and decreases the cost of health care for these patients. Years of refinement in technology and the introduction of safer and less invasive procedures have dramatically reduced the short-term morbidities and long-term metabolic consequences of these procedures. This address will review the field of weight loss (bariatric) surgery and will offer a compelling request for A.S.P.E.N. to include obesity in its fabric.

Implantable Gastric Stimulation - the surgical procedure: combining safety with simplicity.

Implantable Gastric Stimulation is a safe and minimally invasive surgical therapy currently under investigation for the treatment for severe obesity. Over 500 patients have been implanted internationally, and thus far, there have been no major complications or mortalities. While this technology is proving to be the least morbid of the bariatric surgical procedures, it still has the potential to result in devastating complications because of the high-risk nature of operating on severely obese patients. Keeping the risk of a complication to a minimum requires careful attention to preoperative patient preparation, good operative technique, and comprehensive perioperative patient care. In addition, like for all bariatric procedures, the program must have the appropriate equipment and resources to serve this unique patient population. This review will highlight the most significant aspects of each issue.

"What are the yanks doing?" the U.S. experience with implantable gastric stimulation (IGS) for the treatment of obesity - update on the ongoing clinical trials.

BACKGROUND: The prevalence of obesity is growing worldwide. Medical therapies are often ineffective, and surgical treatments have significant risk. IGS(R) offers a novel approach to weight loss that was found to be safe and effective in European trials. In the U.S., 2 consecutive trials have been undertaken. METHODS: In 2000, a multicenter, prospective, randomized, placebo-controlled trial involving 103 morbidly obese patients (U.S. O-01) was undertaken. In 2002, a prospective, open label trial involving 30 morbidly obese patients was initiated (DIGEST). Patients were followed for complications, postoperative untoward events, and weight loss. RESULTS: In O-01, there were no significant perioperative complications. However, 20 patients were found to have had lead dislodgements. At 7 months, there was no significant difference in weight loss between the activated and non-activated groups. After 29 months, loss of excess weight (EWL) approached 20%. With DIGEST, there was 1 operative complication (a lost needle retrieved surgically). There were no untoward events or known lead dislodgements. EWL was 23% after only 16 months follow-up. With the introduction of a preoperative screening algorithm, almost 40% EWL was achieved for selected patients in both trials. CONCLUSIONS: In the U.S., the IGS system for the treatment of obesity has been shown to be safe. Technical improvements and better patient selection resulted in improved weight loss. The preliminary results of these trials suggest that IGS may be a suitable surgical option for selected patients.

Implantable gastric stimulation for the treatment of severe obesity.

The prevalence of obesity is growing worldwide at an alarming rate. Current medical therapies are often ineffective and surgical treatments result in weight loss but have significant risk. Implantable Gastric Stimulation (IGS) offers a novel approach to weight loss. Simply stated, the IGS system electrically stimulates the stomach with a pacemaker-like device. The device is implanted in a brief minimally invasive procedure. Investigation in over 500 patients globally has proven it to be safe and seemly free of long-term sequelae. With refinements in patient selection and device application, the weight loss results have been steadily improving. The IGS may someday become a reliable and safe surgical option for weight loss.

Implantable gastric stimulation for weight loss.

With the epidemic of obesity worldwide, bariatric surgery has rapidly grown in popularity. Currently, a variety of surgical procedures are performed including Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, vertical banded gastroplasty, and biliopancreatic diversion. All of these procedures have been shown to succeed in achieving significant and sustainable weight loss for the majority of patients. However, these procedures also carry the potential for serious operative morbidity, altered gastrointestinal anatomy or function, or both. Electrical gastric stimulation via the implantable gastric stimulation (IGS) system is a relatively new and novel approach to treat obesity. The operative technique is relatively simple and the system does not alter gastrointestinal anatomy. Preliminary worldwide investigations have demonstrated safety and efficacy. This article will review the current experience with the IGS system.