Alfons Pomp

Bariatric surgery versus conventional medical therapy for type 2 diabetes

BACKGROUND Roux-en-Y gastric bypass and biliopancreatic diversion can markedly ameliorate diabetes in morbidly obese patients, often resulting in disease remission. Prospective, randomized trials comparing these procedures with medical therapy for the treatment of diabetes are needed. METHODS In this single-center, nonblinded, randomized, controlled trial, 60 patients between the ages of 30 and 60 years with a body-mass index (BMI, the weight in kilograms divided by the square of the height in meters) of 35 or more, a history of at least 5 years of diabetes, and a glycated hemoglobin level of 7.0% or more were randomly assigned to receive conventional medical therapy or undergo either gastric bypass or biliopancreatic diversion. The primary end point was the rate of diabetes remission at 2 years (defined as a fasting glucose level of <100 mg per deciliter [5.6 mmol per liter] and a glycated hemoglobin level of <6.5% in the absence of pharmacologic therapy). RESULTS At 2 years, diabetes remission had occurred in no patients in the medical-therapy group versus 75% in the gastric-bypass group and 95% in the biliopancreatic-diversion group (P<0.001 for both comparisons). Age, sex, baseline BMI, duration of diabetes, and weight changes were not significant predictors of diabetes remission at 2 years or of improvement in glycemia at 1 and 3 months. At 2 years, the average baseline glycated hemoglobin level (8.65±1.45%) had decreased in all groups, but patients in the two surgical groups had the greatest degree of improvement (average glycated hemoglobin levels, 7.69±0.57% in the medical-therapy group, 6.35±1.42% in the gastric-bypass group, and 4.95±0.49% in the biliopancreatic-diversion group). CONCLUSIONS In severely obese patients with type 2 diabetes, bariatric surgery resulted in better glucose control than did medical therapy. Preoperative BMI and weight loss did not predict the improvement in hyperglycemia after these procedures. (Funded by Catholic University of Rome; ClinicalTrials.gov number, NCT00888836.).

Perioperative safety in the longitudinal assessment of bariatric surgery.

BACKGROUND To improve decision making in the treatment of extreme obesity, the risks of bariatric surgical procedures require further characterization. METHODS We performed a prospective, multicenter, observational study of 30-day outcomes in consecutive patients undergoing bariatric surgical procedures at 10 clinical sites in the United States from 2005 through 2007. A composite end point of 30-day major adverse outcomes (including death; venous thromboembolism; percutaneous, endoscopic, or operative reintervention; and failure to be discharged from the hospital) was evaluated among patients undergoing first-time bariatric surgery. RESULTS There were 4776 patients who had a first-time bariatric procedure (mean age, 44.5 years; 21.1% men; 10.9% nonwhite; median body-mass index [the weight in kilograms divided by the square of the height in meters], 46.5). More than half had at least two coexisting conditions. A Roux-en-Y gastric bypass was performed in 3412 patients (with 87.2% of the procedures performed laparoscopically), and laparoscopic adjustable gastric banding was performed in 1198 patients; 166 patients underwent other procedures and were not included in the analysis. The 30-day rate of death among patients who underwent a Roux-en-Y gastric bypass or laparoscopic adjustable gastric banding was 0.3%; a total of 4.3% of patients had at least one major adverse outcome. A history of deep-vein thrombosis or pulmonary embolus, a diagnosis of obstructive sleep apnea, and impaired functional status were each independently associated with an increased risk of the composite end point. Extreme values of body-mass index were significantly associated with an increased risk of the composite end point, whereas age, sex, race, ethnic group, and other coexisting conditions were not. CONCLUSIONS The overall risk of death and other adverse outcomes after bariatric surgery was low and varied considerably according to patient characteristics. In helping patients make appropriate choices, short-term safety should be considered in conjunction with both the long-term effects of bariatric surgery and the risks associated with being extremely obese. (ClinicalTrials.gov number, NCT00433810.)

Early Experience with Two-Stage Laparoscopic Roux-en-Y Gastric Bypass as an Alternative in the Super-Super Obese Patient

Background: Surgical management of the supersuper obese patient (BMI >60 kg/m2) has been a challenging problem associated with higher morbidity, mortality, and long-term weight loss failure. Current limited experience exists with a two-stage biliopancreatic diversion and duodenal switch in the supersuper obese patient, and we now present our early experience with a two-stage gastric bypass for these patients. Methods: We completed a retrospective bariatric database and chart review of super-super obese patients who underwent laparoscopic sleeve gastrectomy as a first-stage procedure followed by laparoscopic Roux-en-Y gastric bypass as a second-stage for more definitive treatment of obesity. Results: During a two-year period, 7 patients with BMI 58-71 kg/m2 underwent a two-stage laparoscopic Roux-en-Y gastric bypass by two surgeons at the Mount Sinai Medical Center. 3 patients were female, 4 patients were male, and the average age was 43. Prior to the sleeve gastrectomy, the mean weight was 181 kg with a BMI of 63. Average time between procedures was 11 months. Prior to the second-stage procedure, the mean weight was 145 kg with a BMI of 50 and average excess weight loss of 37 kg (33% EWL). Six patients have had follow-up after the second-stage procedure with an average of 2.5 months. At follow-up the mean weight was 126 kg with a BMI of 44 and average excess weight loss of 51 kg (46% EWL). The mean operative times for the two procedures were 124 and 158 minutes respectively. The average length of stay for all procedures was 2.7 days. 4 patients had 5 complications, which included splenic injury, proximal anastomotic stricture, left arm nerve praxia, trocar site hernia, and urinary tract infection.There were no mortalities in the series. Conclusions: Laparoscopic sleeve gastrectomy with second-stage Roux-en-Y gastric bypass are feasible and effective procedures based on short-term results. This two-stage approach is a reasonable alternative for surgical treatment of the high-risk supersuper obese patient.

Weight Change and Health Outcomes at 3 Years After Bariatric Surgery Among Individuals With Severe Obesity

IMPORTANCE Severe obesity (body mass index [BMI] ≥35) is associated with a broad range of health risks. Bariatric surgery induces weight loss and short-term health improvements, but little is known about long-term outcomes of these operations. OBJECTIVE To report 3-year change in weight and select health parameters after common bariatric surgical procedures. DESIGN AND SETTING The Longitudinal Assessment of Bariatric Surgery (LABS) Consortium is a multicenter observational cohort study at 10 US hospitals in 6 geographically diverse clinical centers. PARTICIPANTS AND EXPOSURE: Adults undergoing first-time bariatric surgical procedures as part of routine clinical care by participating surgeons were recruited between 2006 and 2009 and followed up until September 2012. Participants completed research assessments prior to surgery and 6 months, 12 months, and then annually after surgery. MAIN OUTCOMES AND MEASURES Three years after Roux-en-Y gastric bypass (RYGB) or laparoscopic adjustable gastric banding (LAGB), we assessed percent weight change from baseline and the percentage of participants with diabetes achieving hemoglobin A1c levels less than 6.5% or fasting plasma glucose values less than 126 mg/dL without pharmacologic therapy. Dyslipidemia and hypertension resolution at 3 years was also assessed. RESULTS At baseline, participants (N = 2458) were 18 to 78 years old, 79% were women, median BMI was 45.9 (IQR, 41.7-51.5), and median weight was 129 kg (IQR, 115-147). For their first bariatric surgical procedure, 1738 participants underwent RYGB, 610 LAGB, and 110 other procedures. At baseline, 774 (33%) had diabetes, 1252 (63%) dyslipidemia, and 1601 (68%) hypertension. Three years after surgery, median actual weight loss for RYGB participants was 41 kg (IQR, 31-52), corresponding to a percentage of baseline weight lost of 31.5% (IQR, 24.6%-38.4%). For LAGB participants, actual weight loss was 20 kg (IQR, 10-29), corresponding to 15.9% (IQR, 7.9%-23.0%). The majority of weight loss was evident 1 year after surgery for both procedures. Five distinct weight change trajectory groups were identified for each procedure. Among participants who had diabetes at baseline, 216 RYGB participants (67.5%) and 28 LAGB participants (28.6%) experienced partial remission at 3 years. The incidence of diabetes was 0.9% after RYGB and 3.2% after LAGB. Dyslipidemia resolved in 237 RYGB participants (61.9%) and 39 LAGB participants (27.1%); remission of hypertension occurred in 269 RYGB participants (38.2%) and 43 LAGB participants (17.4%). CONCLUSIONS AND RELEVANCE Among participants with severe obesity, there was substantial weight loss 3 years after bariatric surgery, with the majority experiencing maximum weight change during the first year. However, there was variability in the amount and trajectories of weight loss and in diabetes, blood pressure, and lipid outcomes. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00465829.

Laparoscopic gastric bypass versus laparoscopic adjustable gastric banding: a comparative study of 1,200 cases☆

BACKGROUND Indications for and results of laparoscopic adjustable gastric banding (LAGB) and laparoscopic gastric bypass (LGB) are still controversial, especially between Europe and the United States. The recent availability of gastric bandings in the United States made it necessary to compare the two techniques. STUDY DESIGN We compared a series of 456 LGB to a series of 805 LAGB performed in two different institutions. Body mass index (BMI), complication rate, mortality, and excess weight loss (EWL) after 3, 6, 12, and 18 months were obtained. A Fischers exact test and a Student t test with covariance analysis were used for statistical analysis. RESULTS Results are expressed as a mean +/- standard deviation, comparing LGB with LAGB. Preoperative BMI was 49.4 +/- 8.3 kg/m(2) versus 42.2 +/- 4.9 kg/m(2) (p = 0.0001), respectively. Perioperative major complication rates were 2.0% versus 1.3% (NS), and the early postoperative major complication rates were 4.2% versus 1.7% (p = 0.02), respectively. Mortality rate was 0.4% versus 0% (NS), respectively. The global EWL was 36.3% for LGB versus 14.7% for LAGB at 3 months (p < 0.0001), 51.6% versus 21.9% at 6 months (p < 0.0001), 67.0% versus 33.3% at 12 months (p < 0.0001), and 74.6% versus 40.4% at 18 months (p < 0.0001), respectively. Longterm followup for the LAGB group showed an EWL of 47% at 2 years, 56% at 3 years, and 58% at 4 years. Patients were sorted after their preoperative BMI (30 to 40, 40 to 50, and 50 to 60 kg/m(2)). The EWL at 3, 6, 12, and 18 months was statistically superior in the LGB group, for any BMI ranges. CONCLUSIONS These data suggest that LGB provides a higher EWL at 18 months, compared with LAGB, and this was true for any preoperative BMI range. It is associated with a higher early postoperative complication rate.

Decreased bleeding after laparoscopic sleeve gastrectomy with or without duodenal switch for morbid obesity using a stapled buttressed absorbable polymer membrane.

Background: Laparoscopically performed sleeve gastrectomy may be employed as an adjunct to biliopancreatic diversion with duodenal switch (BPD-DS), to induce early satiety and weight loss in morbidly obese patients. Complications from this gastric procedure include staple-line leakage or hemorrhage. The efficacy of a staple-line buttressing material, an absorbable polymer membrane (Seamguard®, Gore), in reducing these complications, was investigated. Methods: A prospective consecutive series of 20 patients who underwent a laparoscopic sleeve gastrectomy in conjunction with BPD-DS were studied. In 10 patients, the absorbable polymer membrane was integrated into the gastric linear staple-line (group A). In a control group of 10 patients, a conventional linear stapling system was used (group B). The following data were recorded: demographics, intraoperative blood loss, staple-line leakage and hospital stay. Results: Demographic profile was similar in both groups. Operative data, including type, duration and strategy of operation as well as surgeons experience were well matched. Peroperative blood loss (120 ml vs 210 ml) was significantly higher in group B (P <0.05). Median length of hospital stay was 3.8 days (range 2-8 days) in group A and 4.6 days (range 4-12 days) in group B. There was no mortality. Morbidity was encountered in 3 patients (all group B), including 2 staple-line hemorrhages (10%) and 1 subphrenic abscess (5%). Conclusion: These early results may show that Seamguard® reduces staple-line hemorrhage and leakage. This may have contributed to shorter hospital stay, decreased costs and lower morbidity after laparoscopic bariatric surgery.

Laparoscopic Reoperative Bariatric Surgery: Experience from 27 Consecutive Patients

Background: 10 to 25% of patients undergoing bariatric surgery will require a revision, either for unsatisfactory weight loss or for complications. Reoperation is associated with a higher morbidity and has traditionally been done in open fashion.The purpose of this study was to determine the safety and efficacy of reoperative surgery using a laparoscopic approach. Methods: A retrospective review of medical records over a 22-month period was conducted. 27 consecutive obesity surgery patients, who had undergone a laparoscopic revision, were identified. 26 of the 27 patients were women. The average age was 40.3 years (range 20 to 58 years) and average original preoperative body mass index (BMI) was 51.6 kg/m2 (range 42 to 66.5).The 27 primary bariatric operations consisted of vertical banded gastroplasty (12), gastric band placement (9) and gastric bypass (6). 17 of them were open procedures. After the primary surgery, the lowest average BMI was 37.6 kg/m2 (range 21 to 52), which increased to 42.7 kg/m2 (range 29 to 56) before reoperation. 24 of the 27 reoperations were indicated for insufficient weight loss. On average, revision was undertaken 52 months after the primary procedure (range 12 to 240 months). Results: 24 of the 27 laparoscopic reoperations were conversions to a gastric bypass. A second reoperation was indicated for insufficient weight loss on four occasions. In one case, conversion to open surgery was required. The average operative time was 232 ± 18.5 minutes (range 120 to 480) and length of hospital stay was 3.7 days (range 1 to 9). 22% percent of patients (6) experienced complications, including pneumothorax, gastric remnant dilation, gastrojejunostomy stenosis, port-site hernia and protein malnutrition. There was no mortality in the study.The average BMI was 35.9 kg/m2 (range 27 to 45.5) 8 months after surgery (range 1 to 22 months). Compared with a preoperative BMI of 42.7 kg/m2, the weight loss was statistically significant (p<0.001). Conclusion: Our results compare favorably with those reported for open reoperative bariatric surgery. A laparoscopic approach may be considered a feasible and safe alternative to an open operation.

Laparoscopic sleeve gastrectomy for morbid obesity.

The epidemic of obesity in the United States is a major public health issue and more than a third of adults are now considered obese (body mass index > or = 30 kg/m(2)). Surgery for morbid obesity, bariatric surgery, is the most durable treatment for this disease and about 140,000 cases are performed annually. Laparoscopic sleeve gastrectomy (LSG) has been advocated as the first of a 2-stage procedure for the high-risk, super-obese patient. More recently, LSG has been studied as a single-stage procedure for weight loss in the morbidly obese. LSG has been shown in initial studies to produce excellent excess weight loss comparable with laparoscopic Roux-en-Y gastric bypass in many series with a very low incidence of major complications and death. We describe our technique for LSG.

Critical care of the bariatric patient.

Objective:To synthesize the current literature on care of obese, critically ill, and bariatric surgical patients. Data Source:A MEDLINE/PubMed search from 1966 to August 2005 was conducted using the search terms obesity, bariatric surgery, and critical illness, and a search of the Cochrane Library was also conducted. Data Extraction and Synthesis:An increase in both the prevalence of obesity and the number of bariatric procedures performed has resulted in an increased number of obese and, specifically, bariatric surgical patients who require intensive care unit care. Obesity is a chronic inflammatory state with resultant effects on immune, metabolic, respiratory, cardiovascular, gastrointestinal, hematologic, and renal function. Principles of care of the critically ill obese patient are reviewed and then applied to critically ill bariatric surgical patients. Pharmacotherapy, vascular access, and the presentation and management of both pressure-induced rhabdomyolysis and anastomotic failure after bariatric surgery are also reviewed. Conclusions:Obesity causes a range of pathologic effects on all major organ systems. Knowledge of these effects and issues specific to the intensive care unit care of bariatric patients can help to predict and manage complications in this population.

Symptomatic internal hernias after laparoscopic bariatric surgery.

BackgroundThe aim of this study was to describe the occurrence and clinical characteristics of symptomatic internal hernias (IH) after laparoscopic bariatric procedures.MethodsWe conducted a retrospective review of cases of IH after 1,064 laparoscopic gastric bypasses (LGB) and biliopancreatic diversions with duodenal switch (LBPD-DS) performed from September 1998 to August 2002.ResultsWe documented 35 cases of IH (overall incidence of 3.3%). The IH occurred in 6.0% of patients with retrocolic procedures and 3.3% of patients with antecolic procedures. Most were in the Petersen defect (55.9%) and at the enteroenterostomy site (35.3%). A bimodal presentation was observed, with 22.9% of patients with IH diagnosed in the early postoperative period (2–58 days) and 77.1% in a delayed fashion (187–1,109 days). A laparoscopic approach to the repair of IH was possible in 60.0% of patients. Complications occurred in 18.8% of patients, including one death (2.9%).ConclusionComplete closure of all mesenteric defects is strongly recommended during laparoscopic bariatric procedures to avoid IH and their associated complications.