Effect of reversible intermittent intra-abdominal vagal nerve blockade on morbid obesity: the ReCharge randomized clinical trial.

IMPORTANCE: Although conventional bariatric surgery results in weight loss, it does so with potential short-term and long-term morbidity. OBJECTIVE: To evaluate the effectiveness and safety of intermittent, reversible vagal nerve blockade therapy for obesity treatment. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, sham-controlled clinical trial involving 239 participants who had a body mass index of 40 to 45 or 35 to 40 and 1 or more obesity-related condition was conducted at 10 sites in the United States and Australia between May and December 2011. The 12-month blinded portion of the 5-year study was completed in January 2013. INTERVENTIONS: One hundred sixty-two patients received an active vagal nerve block device and 77 received a sham device. All participants received weight management education. MAIN OUTCOMES AND MEASURES: The coprimary efficacy objectives were to determine whether the vagal nerve block was superior in mean percentage excess weight loss to sham by a 10-point margin with at least 55% of patients in the vagal block group achieving a 20% loss and 45% achieving a 25% loss. The primary safety objective was to determine whether the rate of serious adverse events related to device, procedure, or therapy in the vagal block group was less than 15%. RESULTS: In the intent-to-treat analysis, the vagal nerve block group had a mean 24.4% excess weight loss (9.2% of their initial body weight loss) vs 15.9% excess weight loss (6.0% initial body weight loss) in the sham group. The mean difference in the percentage of the excess weight loss between groups was 8.5 percentage points (95% CI, 3.1-13.9), which did not meet the 10-point target (P = .71), although weight loss was statistically greater in the vagal nerve block group (P = .002 for treatment difference in a post hoc analysis). At 12 months, 52% of patients in the vagal nerve block group achieved 20% or more excess weight loss and 38% achieved 25% or more excess weight loss vs 32% in the sham group who achieved 20% or more loss and 23% who achieved 25% or more loss. The device, procedure, or therapy-related serious adverse event rate in the vagal nerve block group was 3.7% (95% CI, 1.4%-7.9%), significantly lower than the 15% goal. The adverse events more frequent in the vagal nerve block group were heartburn or dyspepsia and abdominal pain attributed to therapy; all were reported as mild or moderate in severity. CONCLUSION AND RELEVANCE: Among patients with morbid obesity, the use of vagal nerve block therapy compared with a sham control device did not meet either of the prespecified coprimary efficacy objectives, although weight loss in the vagal block group was statistically greater than in the sham device group. The treatment was well tolerated, having met the primary safety objective. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01327976.

Personalized identification of abdominal wall hernia meshes on computed tomography.

An abdominal wall hernia is a protrusion of the intestine through an opening or area of weakness in the abdominal wall. Correct pre-operative identification of abdominal wall hernia meshes could help surgeons adjust the surgical plan to meet the expected difficulty and morbidity of operating through or removing the previous mesh. First, we present herein for the first time the application of image analysis for automated identification of hernia meshes. Second, we discuss the novel development of a new entropy-based image texture feature using geostatistics and indicator kriging. Third, we seek to enhance the hernia mesh identification by combining the new texture feature with the gray-level co-occurrence matrix feature of the image. The two features can characterize complementary information of anatomic details of the abdominal hernia wall and its mesh on computed tomography. Experimental results have demonstrated the effectiveness of the proposed study. The new computational tool has potential for personalized mesh identification which can assist surgeons in the diagnosis and repair of complex abdominal wall hernias.

Preoperative risk reduction: strategies to optimize outcomes.

The success of hernia repair is measured by absence of recurrence, appearance of the surgical scar, and perioperative morbidity. Perioperative surgical site occurrence (SSO), defined as infection, seroma, wound ischemia, and dehiscence, increases the risk of recurrent hernia by at least 3-fold. The surgeon should optimize all measures that promote healing, reduce infection, and enhance early postoperative recovery. In the population with ventral hernia, the most common complication in the immediate perioperative period is surgical site infection. This article reviews several preoperative measures that have been reported to decrease SSOs and shorten length of hospital stay.

Mesh choice in ventral hernia repair: so many choices, so little time.

BACKGROUND: Currently, >200 meshes are commercially available in the United States. To help guide appropriate mesh selection, the investigators examined the postsurgical experiences of all patients undergoing ventral hernia repair at their facility from 2008 to 2011 with ≥12 months of follow-up. METHODS: A retrospective review of prospectively collected data was conducted. All returns (surgical readmission, office or emergency visit) for complications or recurrences were examined. The impact of demographics (age, gender, and body mass index [BMI]), risk factors (hernia grade, hernia size, concurrent and past bariatric surgery, concurrent and past organ transplantation, any concurrent surgery, and American Society of Anesthesiologists score), and prosthetic type (polypropylene, other synthetic, human acellular dermal matrix, non-cross-linked porcine-derived acellular dermal matrix, other biologic, or none) on the frequency of return was evaluated. RESULTS: A total of 564 patients had 12 months of follow-up, and 417 patients had 18 months of follow-up. In a univariate regression analysis, study arm (biologic, synthetic, or primary repair), hernia grade, hernia size, past bariatric surgery, and American Society of Anesthesiologists score were significant predictors of recurrence (P < .05). Multivariate analysis, stepwise regression, and interaction tests identified three variables with significant predictive power: hernia grade, hernia size, and BMI. The adjusted odds ratios vs hernia grade 2 for surgical readmission were 2.6 (95% confidence interval [CI], 1.3 to 5.1) for grade 3 and 2.6 (95% CI, 1.1 to 6.4) for grade 4 at 12 months and 2.3 (95% CI, 1.1 to 4.6) for grade 3 and 4.2 (95% CI, 1.7 to 10.0) for grade 4 at 18 months. Large hernia size (adjusted odds ratio vs small size, 3.2; 95% CI, 1.6 to 6.2) and higher BMI (adjusted odds ratio for BMI ≥50 vs 30 to 34.99 kg/m(2), 5.7; 95% CI, 1.2 to 26.2) increased the likelihood of surgical readmission within 12 months. CONCLUSIONS: The present data support the hypothesis that careful matching of patient characteristics to choice of prosthetic will minimize complications, readmissions, and the number of postoperative office visits.

Distribution of 10-year and lifetime predicted risk for cardiovascular disease prior to surgery in the longitudinal assessment of bariatric surgery-2 study.

Primary prevention guidelines recommend calculation of lifetime cardiovascular disease (CVD) predicted risk in patients who may not meet criteria for high short-term (10-year) Adult Treatment Panel III risk for coronary heart disease (CHD). Extreme obesity and bariatric surgery are more common in women who often have low short-term predicted CHD risk. The distribution and correlates of lifetime CVD predicted risk, however, have not yet been evaluated in bariatric surgical candidates. Using established 10-year (Adult Treatment Panel III) CHD and lifetime CVD risk prediction algorithms and presurgery risk factors, participants from the Longitudinal Assessment of Bariatric Surgery-2 study without prevalent CVD (n = 2,070) were stratified into 3 groups: low 10-year (<10%)/low lifetime (<39%) predicted risk, low 10-year (<10%)/high lifetime (≥39%) predicted risk, and high 10-year (≥10%) predicted risk or diagnosed diabetes. Participants were predominantly white (86%) and women (80%) with a median age of 45 years and median body mass index of 45.6 kg/m(2). High 10-year CHD predicted risk was common (36.5%) and associated with diabetes, male gender, and older age, but not with higher body mass index or high-sensitivity C-reactive protein. Most participants (76%) with low 10-year predicted risk had high lifetime CVD predicted risk, which was associated with dyslipidemia and hypertension but not with body mass index, waist circumference, high-density lipoprotein cholesterol, or high-sensitivity C-reactive protein. In conclusion, bariatric surgical candidates without diabetes or existing CVD are likely to have low short-term, but high lifetime CVD predicted risk. Current data support the need for long-term monitoring and treatment of increased CVD risk factors in bariatric surgical patients to maximize lifetime CVD risk decrease (clinical trial registration, Long-term Effects of Bariatric Surgery, indentifier NCT00465829, available at: http://www.clinicaltrials.gov/ct2/results?term=NCT00465829).

Factors in selecting the optimal bariatric procedure for a specific patient and parameters by which to measure appropriate response to surgery.

Bariatric operations are increasingly being used to induce weight loss and ameliorate or cure most of the morbidities that accompany obesity. These procedures not only produce substantial weight loss (>50% body weight), but they cure or ameliorate the comorbidities (diabetes type 2, hypertension, sleep apnea, hyperlipidemia) in the vast majority of patients. These procedures can usually be performed laparoscopically with a mortality of less than 0.5% and a hospital stay of 1 to 3 days. Presently they are the only effective treatment for weight loss in the extremely obese patient (body mass index >/= 35).

Patient and hospital characteristics on the variance of perioperative outcomes for pancreatic resection in the United States: a plea for outcome-based and not volume-based referral guidelines.

HYPOTHESIS: There is an effect of patient and hospital characteristics on perioperative outcomes for pancreatic resection in the United States. DESIGN: Retrospective cohort study. SETTING: Academic research. PATIENTS: Patient data from the Nationwide Inpatient Sample of the Healthcare Cost and Utilization Project from January 1988 to January 2003. MAIN OUTCOME MEASURES: In-hospital mortality, perioperative complications, and mortality following a major complication. RESULTS: A total of 103 222 patients underwent major pancreatic surgery. The annual number of pancreatic resections increased 15.0% during the 16-year study period. Resection for benign pancreatic disease increased 26.8%. Overall in-hospital mortality, perioperative complications, and mortality following a major complication were 6.5%, 35.6%, and 15.6%, respectively. Multivariate analysis demonstrated that significant independent predictors for these 3 perioperative outcomes were advancing age, male sex, medical comorbidity, and hospital volume for each type of pancreatic resection. The in-hospital mortality for pancreatoduodenectomy increases with age and ranges from 1.7% to 13.8% (P < .001). After adjusting for other confounders, the odds of in-hospital mortality for pancreatoduodenectomy, distal pancreatectomy, and total pancreatectomy in those 65 years or older were 4.78-fold, 3.84-fold, and 2.60-fold, respectively, lower in the high-volume hospitals compared with those in the lower-volume hospitals. CONCLUSIONS: Perioperative complications derived from this population-based study were higher than those reported in many case series. A significant disparity was noted in perioperative outcomes among surgical centers across the United States. An outcome-based referral guideline may have an immediate effect on improving the quality of care in patients who undergo pancreatic resection for benign and malignant disease.

Reconstruction of complex abdominal wall hernias using acellular human dermal matrix: a single institution experience.

BACKGROUND: Acellular human dermal matrix (AHDM) has mechanical properties suitable for complex abdominal wall reconstructions and physiologic properties that allow more resistance to infection in contaminated fields. The purpose of this study was to determine which patient and technical factors lead to optimal surgical outcomes. METHODS: A retrospective review was conducted of 144 abdominal wall reconstructions using AHDM over a 33-month period. Data were recorded and analyzed. RESULTS: Fifty-three percent were women. The average age was 55 years, with an average body mass index of 35 kg/m(2). Thirty percent were smokers at the time of repair, and 24% had diabetes. Forty-three percent of the operative fields had some degree of contamination. The indication for operation in half the patients was to reconstruct a previously failed hernia repair. The recurrence rate was 27.1%. The significant factors that affected the recurrence rate were female gender (P = .02), reconstructing a failed prior repair (P = .025), and high body mass index (P = .004). An underlay mesh placement trended to a lower recurrence rate (P = .053). Average follow-up time was 23 weeks (range, 0-100 weeks). CONCLUSIONS: Three patient factors contributed significantly to the recurrence rate in this study: gender, above-normal body mass index, and repairing a recurrent hernia. Placing the matrix as an underlay appears to decrease recurrence rates. Long-term follow-up is needed to further determine the durability of hernia repairs with AHDM. AHDM offers a viable option with acceptable morbidity in complex abdominal wall reconstructions in high-risk patient populations.

Demographic and socioeconomic trends in the use of laparoscopic appendectomy from 1997 to 2003.

BACKGROUND: Because there is conflicting evidence regarding the benefits of laparoscopic appendectomy, we hypothesized that there would be measurable differences in its use among various socioeconomic groups and geographic areas. METHODS: The Nationwide Inpatient Sample was queried for appendectomies performed between the years of 1997 and 2003. Rates of laparoscopic appendectomy were compared among hospital subtypes and demographic groups. RESULTS: The percentage of appendectomies performed laparoscopically has increased from 19.1% in 1997 to 37.9% in 2003. Only 11.8% of cases of complicated appendicitis were treated laparoscopically in 1997, compared with 23.5% in 2003. Nonwhite patients and those from low-income areas continue to be less likely to undergo laparoscopic appendectomy (P < .001). CONCLUSIONS: Our analysis indicates that despite expanding use of laparoscopic appendectomy nationwide, patients who live in zip codes areas with a preponderance of minorities or low-income earners are more likely to have open appendectomy.

Revisional bariatric surgery for failed restrictive procedures.

BACKGROUND: Revisional bariatric surgery is increasing in frequency, but the morbidity and efficacy have not been well defined. The primary aim of this study was to determine the clinical efficacy with respect to weight loss, and associated morbidity, of revisional bariatric surgery in an academic university hospital bariatric surgery program. METHODS: A retrospective review of all patients who underwent revisional bariatric surgery for failed primary restrictive procedures, including gastroplasty and gastric bypass, but not including gastric banding or malabsorptive procedures, during a 10-year period at a single university hospital was performed. The perioperative morbidity and long-term weight loss and clinical results were determined from the medical charts. RESULTS: A total of 41 patients met the inclusion criteria. The primary bariatric procedures included vertical banded gastroplasty in 20 and Roux-en-Y gastric bypass in 21. The indications for revisional surgery included poor weight loss, weight regain, and various technical problems, including anastomotic stenosis and ulcer. The major morbidity rate was 17%. No patients died. The weight loss results varied depending on the indication for the revisional surgery and reoperative solution applied. The resolution of technical problems was achieved in all patients. CONCLUSION: Revisional bariatric surgery can be performed with minimal mortality, albeit significant morbidity. The efficacy with respect to weight loss appeared acceptable, although the results were not as good as those after primary bariatric surgery. The analysis of patient subsets stratified by surgical history and revisional strategy provided important insights into the mechanisms of failure and efficacy of different revisional strategies.

Aggressive pancreatic resection for primary pancreatic neuroendocrine tumor: is it justifiable?

BACKGROUND: Benign and malignant pancreatic neuroendocrine tumors (PNETs) are rare, and long-term outcome is generally poor without surgical intervention. The aim of the study was to assess whether aggressive pancreatic resection is justifiable for patients with PNET. METHODS: All consecutive patients who had undergone major pancreatic resection from January 1997 through January 2005 were reviewed and analyzed. RESULTS: There were 33 patients (16 male and 17 female) with a mean age of 53 years. Five patients had multiple endocrine neoplasms syndrome, and 1 patient had von Hippel-Lindau syndrome. There were 20 benign (9 functional) and 13 malignant (6 functional) neoplasms. Mean tumor size was 4.2 cm, and multiple tumors were noted in 10 patients. Eight patients (25%) underwent pancreticoduedenectomy, and 25 patients (76%) underwent distal pancreatectomy (extended distal pancreatectomy in 4 and splenectomy in 20 patients). Regional lymph node involvement was present in 10 patients (30%), and 6 patients (18%) had liver metastasis. Four patients (12%) underwent concurrent resection of other organs because of disease extension. Median intraoperative blood loss was 500 mL. Perioperative morbidity was 36%, and mortality was 3%. Symptomatic palliation was complete in 93% (14.15 patients) and partial in 1 patient because of nonresectable hepatic disease. Median hospital stay was 11.5 days. After median follow-up of 36 months, there were no local recurrences. The 1-, 3-, and 5-year overall survival rates for patients with benign versus malignant neoplasms were 100% vs. 92%, 89% vs. 64%, and 89% vs 36% (P = .01), respectively. The 1-, 3-, and 5-year disease progression rates for patients with malignant neoplasms were 13%, 63%, and 100%, respectively (P < .0001). CONCLUSIONS: Aggressive pancreatic resection for PNET can be performed with low perioperative mortality and morbidity. Unlike available nonoperative therapy, this approach offers an excellent means of symptomatic palliation and local disease control. In patients with malignant PNET, metastatic recurrence is not uncommon and will usually require additional multimodality therapy. When possible, an aggressive approach to PNET is justified to optimize palliation and survival.

Improved quality of life after bilateral laparoscopic adrenalectomy for Cushing's disease: a 10-year experience.

OBJECTIVE: To determine long-term quality of life after bilateral adrenalectomy for persistent Cushing's disease after transsphenoidal pituitary tumor resection. SUMMARY BACKGROUND DATA: Bilateral adrenalectomy for symptomatic relief of persistent hypercortisolism appears to be an effective treatment option. However, few studies have examined long-term outcomes in this patient population. METHODS: Retrospective review of 39 patients treated by bilateral laparoscopic adrenalectomy for Cushing's disease from 1994 to 2004. Patients completed a follow-up phone survey, including our Cushing-specific questionnaire and the SF-12v2 health survey. Patients then refrained from taking their steroid replacement for 24 hours, and serum cortisol and ACTH levels were measured. RESULTS: Three patients died at 12, 19, and 50 months following surgery from causes unrelated to adrenalectomy. The remaining 36 patients all responded to the study questionnaire (100% response rate). Patients were between 3 months and 10 years post-adrenalectomy. We had zero operative mortalities and a 10.3% morbidity rate. Our incidence of Nelson's syndrome requiring clinical intervention was 8.3%; 89% of patients reported an improvement in their Cushing-related symptoms, and 91.7% would undergo the same treatment again. Twenty of 36 (55%) and 29 of 36 (81%) patients fell within the top two thirds of the national average for physical and mental composite scores, respectively, on the SF-12v2 survey. An undetectable serum cortisol level was found in 79.4% of patients. CONCLUSIONS: Laparoscopic bilateral adrenalectomy for symptomatic Cushing's disease is a safe and effective treatment option. The majority of patients experience considerable improvement in their Cushing's disease symptoms, and their quality of life equals that of patients initially cured by transsphenoidal pituitary tumor resection.

Perioperative morbidity associated with bariatric surgery: an academic center experience.

HYPOTHESIS: As the demand for bariatric surgery increases, it becomes increasingly important to define predictors of morbidity and mortality. We hypothesize that specific clinical variables predict postoperative morbidity after bariatric surgery. DESIGN, SETTING, AND PATIENTS: This is a retrospective review of 452 patients undergoing inpatient bariatric surgery at an academic tertiary care institution. INTERVENTIONS: Patients underwent open or laparoscopic gastric bypass or biliopancreatic diversion with duodenal switch at Oregon Health & Science University, Portland, from 2000 to 2003. Patient data were prospectively entered into a database. MAIN OUTCOME MEASURES: Postoperative morbidity and mortality were analyzed among all patients, and logistic regression was used to identify clinical predictors of morbidity. RESULTS: Major and minor morbidity rates were 10% and 13%, respectively; mortality was 0.9%. Age was associated with postoperative complications (odds ratio = 1.056 for each additional year). Duodenal switch was also associated with higher morbidity than gastric bypass (odds ratio = 2.149). Body mass index, sex, diabetes, surgical approach, and surgeon experience did not predict complications. CONCLUSIONS: Increased age is a predictor of complications after bariatric surgery. Duodenal switch is also associated with a higher morbidity rate than gastric bypass. Surgeons should caution older patients (>/=60 years) of a higher risk of postoperative complications, and a higher risk associated with duodenal switch. Large multicenter studies will be necessary to accurately define other clinical predictors of morbidity and mortality after bariatric surgery.