[Show abstract][Hide abstract] ABSTRACT: IMPORTANCE Emerging data support bariatric surgery as a therapeutic strategy for management of type 2 diabetes mellitus. OBJECTIVE To test the feasibility of methods to conduct a larger multisite trial to determine the long-term effect of Roux-en-Y gastric bypass (RYGB) surgery compared with an intensive diabetes medical and weight management (Weight Achievement and Intensive Treatment [Why WAIT]) program for type 2 diabetes. DESIGN, SETTING, AND PARTICIPANTS A 1-year pragmatic randomized clinical trial was conducted in an academic medical institution. Participants included persons aged 21 to 65 years with type 2 diabetes diagnosed more than 1 year before the study; their body mass index was 30 to 42 (calculated as weight in kilograms divided by height in meters squared) and hemoglobin A1c (HbA1c) was greater than or equal to 6.5%. All participants were receiving antihyperglycemic medications. INTERVENTIONS RYGB (n = 19) or Why WAIT (n = 19) including 12 weekly multidisciplinary group lifestyle, medical, and educational sessions with monthly follow-up thereafter. MAIN OUTCOMES AND MEASURES Proportion of patients with fasting plasma glucose levels less than 126 mg/dL and HbA1c less than 6.5%, measures of cardiometabolic health, and patient-reported outcomes. RESULTS At 1 year, the proportion of patients achieving HbA1c below 6.5% and fasting glucose below 126 mg/dL was higher following RYGB than Why WAIT (58% vs 16%, respectively; P = .03). Other outcomes, including HbA1c, weight, waist circumference, fat mass, lean mass, blood pressure, and triglyceride levels, decreased and high-density lipoprotein cholesterol increased more after RYGB compared with Why WAIT. Improvement in cardiovascular risk scores was greater in the surgical group. At baseline the participants exhibited moderately low self-reported quality-of-life scores reflected by Short Form-36 total, physical health, and mental health, as well as high Impact of Weight on Quality of Life-Lite and Problem Areas in Diabetes health status scores. At 1 year, improvements in Short Form-36 physical and mental health scores and Problem Areas in Diabetes scores did not differ significantly between groups. The Impact of Weight on Quality of Life-Lite score improved more with RYGB and correlated with greater weight loss compared with Why WAIT. CONCLUSIONS AND RELEVANCE In obese patients with type 2 diabetes, RYGB produces greater weight loss and sustained improvements in HbA1c and cardiometabolic risk factors compared with medical management, with emergent differences over 1 year. Both treatments improve general quality-of-life measures, but RYGB provides greater improvement in the effect of weight on quality of life. These differences may help inform therapeutic decisions for diabetes and weight loss strategies in obese patients with type 2 diabetes until larger randomized trials are performed. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01073020.
[Show abstract][Hide abstract] ABSTRACT: Obesity is commonplace, and surgical treatment usually includes Roux-en-Y gastric bypasses (RYGBs). RYGBs have the most documented side effects including vitamin deficiencies, rebound weight gain, and symptomatic hypoglycemia; fewer series exist describing hypoglycemia following other bariatric operations. We reviewed all patients undergoing laparoscopic adjustable gastric banding (LAGB) at our institution between 2008 and 2012. Three patients were identified to have symptomatic hypoglycemia following LAGB. Mean time from surgery was 33 months (range 14-45 months), and mean weight loss was 32.7 kg (range 15.9-43.1 kg). None of the patients had preexisting diabetes. Therefore, symptomatic hypoglycemia should be investigated irrespective of bariatric operation.
Case reports in endocrinology. 01/2013; 2013:671848.
[Show abstract][Hide abstract] ABSTRACT: Laparoscopic adjustable gastric band (LAGB) has gone through major design modifications to improve clinical endpoints and reduce complications. Little is known, however, about the effects of LAGB size on clinical outcomes, or whether outcomes differ based on gender. We set out to examine the impact of band size on surgical weight loss, reoperations, comorbidity resolution, and compare outcomes within gender.
We reviewed our prospectively collected longitudinal bariatric database between 2008 and 2010, and compared patients with BMI 35-50 kg/m(2) who had undergone LAGB with the LAP-BAND® APS to those who had the larger APL. Those patients with initial BMI > 50 kg/m(2) were excluded to reduce any possible selection bias which favors larger band use in such subjects.
Three hundred ninety-four patients met our inclusion criteria; 230 (58 %) in the APS group and 164 (42 %) in the APL group. Female patients in APS group experienced significantly higher percentage excess body weight loss at 6 months, 1 year, and 2 years in comparison to female patients in APL group (p < 0.001 for all time points). In contrast, a reverse pattern was observed for male patients. No significant differences were observed between the groups regarding frequency of band adjustments, complications, or comorbidity resolution.
Male patients might benefit from APL bands, in contrast to female patients who appear to experience superior weight loss with the smaller APS bands. This study provides the first set of evidence to facilitate surgical decision making for band size selection and highlights differences between genders.
Obesity Surgery 05/2012; 22(9):1437-44. · 3.74 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: Retrograde intussusception (RI) at the jejunojejunostomy can occur after Roux-en-Y gastric bypass (RYGB). Although this complication is rare, it has been encountered more frequently as the number of bariatric procedures have increased. Little data is available to assist surgeons with the optimal management of this condition. Our objectives were to identify the risk factors for RI after RYGB and report on outcomes after surgical intervention at a tertiary academic surgical unit. METHODS: We used our prospective longitudinal institutional bariatric surgical database to identify patients with post-RYGB RI from 1996 to 2011. RESULTS: We identified 28 post-RYGB RI cases. The median interval between RYGB and RI was 52 months, and the median percentage of excess weight loss was 75%. Patients presented with acute symptoms in 36% of the cases. All patients underwent surgical exploration, including resection and revision of the jejunojejunostomy (46%) or operative reduction with or without enteropexy (54%). Those undergoing resection had a longer hospital stay but similar 30-day complication rates. At a median follow-up of 9 months, only 1 recurrence was documented. CONCLUSIONS: RI is a rare and late complication of RYGB and typically occurs after significant weight loss. In the presence of ischemia or nonreducible RI, resection and revision of the jejunojejunostomy is recommended. In less acute patients, laparoscopic management with reduction and/or enteropexy offers a reduced hospital length of stay while maintaining equivalent morbidity and low recurrence compared with resection.
Surgery for Obesity and Related Diseases 05/2012; · 4.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Experts become automated when performing surgery, making it difficult to teach complex procedures to trainees. Cognitive task analysis (CTA) enables experts to articulate operative steps and cognitive decisions in complex procedures such as laparoscopic appendectomy, which can then be used to identify central teaching points.
Three local surgeon experts in laparoscopic appendectomy were interviewed using critical decision method-based CTA methodology. Interview transcripts were analyzed, and a cognitive demands table (CDT) was created for each expert. The individual CDTs were reviewed by each expert for completeness and then combined into a master CDT. Percentage agreement on operative steps and decision points was calculated for each expert. The experts then participated in a consensus meeting to review the master CDT. Each surgeon expert was asked to identify in the master CDT the most important teaching objectives for junior-level and senior-level residents. The experts' responses for junior-level and senior-level residents were compared using a χ(2) test.
The surgeon experts identified 24 operative steps and 27 decision points. Eighteen of the 24 operative steps (75%) were identified by all 3 surgeon experts. The percentage of operative steps identified was high for each surgeon expert (96% for surgeon 1, 79% for surgeon 2, and 83% for surgeon 3). Of the 27 decision points, only 5 (19%) were identified by all 3 surgeon experts. The percentage of decision points identified varied by surgeon expert (78% for surgeon 1, 59% for surgeon 2, and 48% for surgeon 3). When asked to identify key teaching points, the surgeon experts were more likely to identify operative steps for junior residents (9 operative steps and 6 decision points) and decision points for senior residents (4 operative steps and 13 decision points) (P < .01).
CTA can deconstruct the essential operative steps and decision points associated with performing a laparoscopic appendectomy. These results provide a framework to identify key teaching principles to guide intraoperative instruction. These learning objectives could be used to guide resident level-appropriate teaching of an essential general surgery procedure.
American journal of surgery 02/2012; 203(4):540-5. · 2.36 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: BACKGROUND: We hypothesized that laparoscopic adjustable gastric band (LAGB) placement might result in the development of a hiatal hernia (HH) over time. The objective of our study was to determine whether HHs develop after LAGB in the setting of a university hospital. METHODS: We retrospectively reviewed all outcomes for consecutive LAGB patients in our institutional, longitudinal prospective bariatric surgical database to identify those patients without evidence of a HH at LAGB placement, who subsequently underwent delayed HH repair. RESULTS: From 2005 to 2009, 695 gastric bands were implanted. Twelve patients (1.72%) were identified who had no radiographic or intraoperative evidence of a HH at LAGB placement and who subsequently underwent HH repair at re-exploration. Patients presented 18 ± 10 months after band placement. Of these patients, 75% presented with gastroesophageal reflux disease or food intolerance (50% with gastroesophageal reflux disease alone). Also, 2 presented with acute pain due to band slippage and 1 with chronic pain and vomiting. In 50% of the patients, revision procedures detected the HH at operation despite negative preoperative studies. CONCLUSION: In our series, a significant HH developed in 1.7% of LAGB patients who had no clinically identifiable HH at LAGB placement. Persistent dysphagia after band deflation requires careful inspection of the hiatus during surgical revision, even in the absence of radiologic depiction of HH, and might represent an underlying etiology of LAGB dysfunction. This complication, along with esophageal dilation and annular pouch dilation, might represent a constellation of conditions with a common etiology. From the results of our small series, we raise the question of the existence of chronic backpressure created by LAGB restriction and accounting for these complications.
Surgery for Obesity and Related Diseases 08/2011; · 4.94 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Adipose tissue (AT) can accumulate macrophages and secrete several inflammatory mediators. Despite its pivotal role in the progression of chronic inflammatory processes such as atherosclerosis, the adaptive role of immunity in obesity remains poorly explored. Visceral AT of diet-induced obese C57BL/6 mice had higher numbers of both CD4(+) and CD8(+) T cells than lean controls, monitored by flow cytometry. When stimulated in vitro, T cells from obese AT produced more interferon (IFN)gamma than those from controls. AT from obese animals also had more cells expressing I-A(b), a mouse class II histocompatibility marker implicated in antigen presentation, as determined by immunostaining. Differentiated 3T3-L1 cells stimulated with recombinant IFNgamma or T-helper 1-derived supernatant produced several chemokines and their mRNAs. Obese IFNgamma-deficient animals had significantly reduced AT expression of mRNA-encoding inflammatory genes such as tumor necrosis factor-alpha and monocyte chemoattractant protein-1, decreased AT inflammatory cell accumulation, and better glucose tolerance than control animals consuming the same diet. Obese mice doubly deficient for IFNgamma receptor and apolipoprotein (Apo)E on a mixed 129SvEv/C57BL/6 (129/B6) genetic background, despite exhibiting similar AT mRNA levels of tumor necrosis factor-alpha and monocyte chemoattractant protein-1 as 129/B6-ApoE(-/-) controls, had decreased expression of important T cell-related genes, such as IFNgamma-inducible protein-10 and I-A(b), and lower plasma triglycerides and glucose. These results indicate a role for T cells and IFNgamma, a prototypical T-helper 1 cytokine, in regulation of the inflammatory response that accompanies obesity.
Circulation Research 08/2008; 103(5):467-76. · 11.09 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The appropriate management of biliary tract disease during pregnancy is uncertain. Although laparoscopic cholecystectomy can be performed safely during pregnancy, the timing and indications for this surgical intervention have not been firmly established.
We constructed a Markov decision analytic model that incorporates maternal well-being and fetal outcome into a choice between nonoperative management (NM) and laparoscopic cholecystectomy (LC) for pregnant women with biliary tract disease (BTD). Our model cycles through weeks of pregnancy for a cohort of 200 gravid women presenting with biliary tract disease in both the first and second trimesters. Weekly state probabilities and utilities for fetal outcome were derived from the literature, while weekly utilities for disease and operative states were estimated in consultation with obstetricians. We cycled the model from 6 to 42 weeks and from 19 to 42 weeks to simulate first and second trimester presentations. Outcomes are expressed in quality pregnancy weeks (QPWs). One QPW is the utility of a normal healthy week of pregnancy.
A comprehensive search of the literature yielded a fetal death rate following LC for biliary tract disease of 2.2% and following NM of 7%. Relapse rates were found to be trimester dependent and estimated to be 55%, 55%, and 40% in the first, second, and third trimester, respectively. For a hypothetical cohort of 100 women presenting with biliary tract disease in their first trimester, LC generated 12,800 QPWs compared with 12,400 QPWs for NM, an average gain of 4 QPWs per woman. For the cohort of women entering the model in the second trimester, 11,600 QPWs were accrued by the LC group and 11,400 QPWs by the NM group, an average gain of 2 QPWs per woman. These findings were sensitive only to changes in fetal death rates under the two treatment arms.
Laparoscopic cholecystectomy is superior to nonoperative management for pregnant women presenting in the first or second trimester with biliary tract disease.