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.

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).

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.

Gastro-gastric fistula in the era of divided Roux-en-Y gastric bypass: strategies for prevention, diagnosis, and management.

Roux-en-Y gastric bypass (RYGBP) is a mainstay of bariatric surgical therapy. Gastro-gastric fistula (GGF) is an infrequent but potentially serious complication of gastric bypass, and diagnosis may be difficult. We report two patients who underwent RYGBP complicated by development of GGF who nevertheless achieved excellent, durable weight loss. The pathogenesis, diagnosis, prevention and management of GGF after RYGBP is reviewed. GGF may not result in poor weight loss after RYGBP and is not an absolute indication for surgical revision.

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.

Common channel length predicts outcomes of biliopancreatic diversion alone and with the duodenal switch surgery.

BACKGROUND: The optimal common channel (CC) length for malabsorptive weight loss surgeries is unknown even though these surgeries were developed in the 1970s (biliopancreatic diversion [BPD]) and the 1990s (biliopancreatic diversion with a duodenal switch [BPD DS]). We hypothesized that the length of the CC correlates with a successful weight loss result. METHODS: We evaluated 3 groups of patients based on the length of the CC whose duration of follow-up evaluation was at least 1 year. We reviewed all patients who had either an open BPD (5 patients) or a BPD DS (119 patients) from August 1998 to October 2003, for which D.B.M. was the participating surgeon. RESULTS: Group I comprised 15 patients: their preoperative body mass index (BMI) was 53.9 kg/m(2); 73.3% of patients had a BMI more than 50, and the CC length was 150 cm. Group II comprised 76 patients: their preoperative BMI was 54.25 kg/m(2); 73.3% of patients had a BMI more than 50, and the CC length was 100 cm. Group III comprised 33 patients: their preoperative BMI was 60.1 kg/m(2); 84% of patients had a BMI more than 50, and the CC length was 80 to 90 cm. The mean weight loss in group I was 45 kg (44% mean excess weight loss). The mean weight loss in groups II and III was 55.8 and 61.5 kg, respectively (a 57% and 54.8% mean excess weight loss, respectively) (all P < .05 by analysis of variance). A weight loss of greater than 50% of excess body weight occurred in 40% of patients in group I versus 63% of patients in groups II and III combined (P < .01 by chi(2)). CONCLUSIONS: The length of the CC contributes significantly to successful excess weight loss in BPD and BPD DS patients. In general, the length of the CC should not exceed 100 cm.

Quality of life after laparoscopic bilateral adrenalectomy for Cushing's disease.

BACKGROUND: Bilateral adrenalectomy to control symptoms of Cushing's disease after failed transsphenoidal operation is effective. We examined surgical outcomes and quality of life after laparoscopic bilateral adrenalectomy for the treatment of Cushing's disease. METHODS: Eighteen patients underwent laparoscopic bilateral adrenalectomy from November 1994 through December 2000. Patient data were obtained from chart reviews. Patients completed a follow-up survey including the SF-36 health survey (QualityMetric Inc, Lincoln, Neb). RESULTS: Laparoscopic bilateral adrenalectomy was accomplished in all 18 patients. There was 1 intraoperative complication of a colotomy, and 2 postoperative complications including 1 pancreatic pseudocyst and 1 hemorrhage. Three patients died at 12, 19, and 50 months after operation. At a median follow-up of 29 months, patients reported improvement in all Cushing's-related symptoms. Nine of 11 patients who responded to the survey stated their heath was improved after adrenalectomy. Results of the SF-36 health survey showed significantly lower scores in all 8 measured parameters when compared with the general population. CONCLUSIONS: Results of laparoscopic bilateral adrenalectomy show this procedure is comparable with open adrenalectomy in controlling symptoms of Cushing's disease. Despite patient reported improvement in health after adrenalectomy, this patient population continues to experience poor health as measured by the SF-36 when compared with the general population.

Clostridium difficile colitis: an increasingly aggressive iatrogenic disease?

HYPOTHESIS: The diagnosis of Clostridium difficile colitis is increasing in frequency, with worsening patient outcomes. DESIGN: Retrospective cohort study. SETTING: University hospital. PATIENTS: One hundred fifty-seven patients diagnosed with C difficile colitis between 1994-2000. MAIN OUTCOME MEASURES: Resolution of disease, operative intervention, and death. RESULTS: Compared with our previous 10-year experience, overall cases of C difficile colitis have risen by more than 30%, and immunocompromised patients comprise a larger proportion of those affected. One third of patients were receiving posttransplantation medication, chemotherapy, or had human immunodeficiency virus. Of these, 2 (4%) of 51 required surgical intervention and 10 (20%) of 51 died. An additional 18.5% of patients had diabetes, renal failure, or both. Of these, 2 (7%) of 30 required surgery and 4 (13%) of 30 died. Only 9.5% of patients had prophylactic perioperative antibiotics as a sole risk factor; 2 (13%) of 15 required surgery and 3 (20%) of 15 died. The overall mortality rate was 15.3%, increased from 3.5% in our previous series. Neither need for surgery nor mortality differed among these patient groups. CONCLUSIONS: The frequency of C difficile colitis remains high and seems to be associated with increasing mortality. Among patients with positive C difficile toxin assay results, immunocompromise and delayed diagnosis no longer seem to be associated with higher risk for death. All patients taking antibiotics are at risk and require early recognition and aggressive medical intervention.

Laparoscopic management of giant type III hiatal hernia and short esophagus. Objective follow-up at three years.

We wished to evaluate the long-term effectiveness of the laparoscopic Hill repair in the treatment of type III hiatal hernia. Fifty-two patients underwent laparoscopic repair of a type III hiatal hernia. No esophageal lengthening procedures were performed. Short esophagus was determined from the operative record. Late symptomatic follow-up and a satisfaction questionnaire were completed in 71% (37/52) of patients at a mean of 39 months (range 6 to 84 months). Esophagrams were completed in 65% (34/52) of patients at a mean of 37 months (range to 84 months) after repair. Eighty-one percent were without any adverse symptoms, and 86% rated outcome as excellent or good at 39 months. Symptoms requiring treatment were present in 19% (7/37). Esophagrams revealed a recurrent hernia in 32% (11/34) of patients of whom 36% (4/11) were asymptomatic. Six patients with short esophagus underwent esophagram with one recurrence identified (17%). This was compared with 28 patients without short esophagus, of whom 10 had a recurrence (35%) (P = 0.70). The laparoscopic Hill repair provides long-term satisfaction and relief of symptoms. The incidence of anatomic recurrence on video esophagram is high and does not always correlate with symptoms. The presence of short esophagus does not play a role in recurrence when the Hill repair is used.

Helicobacter pylori induces apoptosis in Barrett's-derived esophageal adenocarcinoma cells.

Helicobacter pylori may protect against the development of dysplasia in Barrett's epithelium of patients with gastroesophageal reflux disease. The aim of this study was to determine whether H. pylori preferentially induces apoptosis in Barrett's-derived cancer cells compared to normal cells. A Barrett's-derived adenocarcinoma cell line (OE33) was grown. H. pylori wild-type, isogenic vacA-, cagA(-), and picB-/cagE- mutant strains were grown on agar plates. Intact or sonicated bacteria were used to treat normal and OE33 cells for 24 hours, and Hoechst dye binding was performed to measure apoptosis. FAS protein expression was determined by Western immunoblotting. OE33 cells treated with intact H. pylori wild-type strains produced significant (P < 0.05) dose-dependent increases in apoptosis compared to normal esophageal cells. H. pylori wild-type and vacA- isogenic strains were more effective than cagA- and picB-/cage- isogenic strains in inducing apoptosis in OE33 cells. In OE33 cells, H. pylori sonicates produced lower levels of apoptosis than intact bacteria. Wild-type H. pylori strains increased Fas protein expression in OE33 cells at 18 hours. H. pylori induced apoptosis at a higher rate in the Barrett's-derived human esophageal adenocarcinoma cells than in normal esophageal cells. The H. pylori-induced apoptosis was primarily dependent on intact bacteria and the presence of the cagA and picB/cagE gene products. H. pylori-induced apoptosis may involve the Fas-caspase cascade.

Roux-en-Y divided gastric bypass results in the same weight loss as duodenal switch for morbid obesity.

BACKGROUND: The 2 weight loss procedures most commonly performed in the United States are Roux-en-Y gastric bypass (RYGBP) and lateral gastrectomy with duodenal switch (BPD/DS). RYGB is a restrictive procedure, whereas BPD/DS relies on mild restriction of intake as well as malabsorption. Many physicians believe that weight loss is greater after BPD/DS than after RYGBP. However, these procedures have not been compared using groups of patients operated on by the same surgeons at the same institution. METHODS: We compared weight loss (expressed as percent of excess body weight [%EBW]) after 1 and 2 years in patients who underwent open RYGB or BPD/DS at our institution. RESULTS: Average length of stay was longer in BPD/DS patients than in those undergoing RYGBP (8.7 vs. 5.9 days, P <0.05). Anastomotic leaks were higher after BPD/DS (6% vs. 3%), but the difference did not achieve statistical significance. Mortality did not differ between the 2 groups (0.8% vs. 0.9%). In the group of patients followed-up for 1 to 2 years, age and distribution of men and women did not differ. Those patients undergoing BPD/DS had higher body mass index (59 vs. 55, P <0.05). Weight loss expressed as %EBW was similar between the 2 groups: 54% versus 53% at 1 year and 67% versus 64% at 2 years. CONCLUSIONS: Our data suggested that weight loss expressed as %EBW is similar between patients undergoing RYGBP and those undergoing BPD/DS. However, BPD/DS was associated with a longer hospital stay.

Surgical complications of bone marrow transplantation.

BACKGROUND: We wished to determine the type of diseases in patients who received bone marrow transplant (BMT) that potentially involve the general surgeon at our institution. METHODS: The records of 542 patients who underwent bone marrow transplant at Oregon Health and Sciences University between January 1990 and December 2000 were retrospectively reviewed. Gastrointestinal complications included in the study were gastrointestinal bleeding, venoocclusive disease of the liver, intestinal graft versus host disease, pneumatosis intestinalis, necrotizing enteritis, as well as other more common surgical diseases (eg, appendicitis). RESULTS: Gastrointestinal complications or surgical consultations were noted in 92 of 542 patients (17%). Of these, formal general surgical consultation was obtained in 48 patients (9%). The most common causes for surgical consult were cholecystitis (5), abdominal pain of unknown etiology (5), central line complications (5), small bowel obstruction (4), and appendicitis (4). Twenty-eight (58%) of these patients received an operation. Six patients (13%) died during the same hospitalization as their surgery consult. Forty-four patients with these gastrointestinal symptoms related to transplantation did not receive surgical consult. The mortality in this group was 45%. CONCLUSIONS: The majority of gastrointestinal complications after bone marrow transplant do not require surgical intervention. However, these conditions may overlap the more common reasons for surgical consult and must be identifiable by the general surgeon. Of patients who did require surgical intervention, it was primarily for common surgical diseases.

Delayed celiotomy for the treatment of bile leak, compartment syndrome, and other hazards of nonoperative management of blunt liver injury.

BACKGROUND: Management of blunt liver injury is predominantly nonoperative. However, complications occur in 10% to 25% of patients, with half taking place more than 24 hours after injury. Few reports have addressed the management of the new pattern of these delayed complications, which is the objective of this study. METHODS: Adult patients admitted to our level one trauma center from 1995 to 2000 with blunt liver injury were identified. Demographic, physiologic and laboratory data, computed tomography (CT) and operative findings, and complications were reviewed. RESULTS: Blunt liver injury was identified in 192 patients. Thirty-nine patients (20%) underwent immediate celiotomy. The remaining 153 patients were initially managed nonoperatively. Liver-related complications developed in 19 (12%) patients. Fifteen patients underwent delayed celiotomy to treat secondary inflammatory processes, from bile leak (6), hemorrhage (5), and hepatic abscess (1), and to treat abdominal compartment syndrome (2), and decompress hepatic compartment syndrome (1). Although no deaths or complications were directly caused by delayed celiotomy, 2 deaths (11%), occurring early in this series, were attributed to liver-related complications. CONCLUSIONS: These complications, occurring in 12% of patients with liver injuries, may be a consequence of initial nonoperative management. Although these findings do not negate nonoperative management of blunt liver injury, this approach can be hazardous and requires diligence to recognize and treat delayed and potentially fatal complications.

Surgical management of gastroesophageal reflux and outcome after laryngectomy in patients using tracheoesophageal speech.

BACKGROUND: Gastroesophageal reflux disease (GERD) is common in patients with head and neck carcinoma. The impact of laparoscopic fundoplication on laryngectomy patients with tracheoesophageal prostheses for voice restoration is unknown. METHODS: Nine laryngectomy patients who use tracheoesophageal speech underwent laparoscopic fundoplication for documented reflux. Preoperative and postoperative symptoms were recorded. Quality of speech was documented before and after fundoplication. RESULTS: Although 88% of patients had resolution of GERD symptoms, all developed bloating and hyperflatulence. There was no difference in quality of esophageal speech after laparoscopic fundoplication. CONCLUSIONS: Fundoplication in laryngectomy patients that use tracheoesophageal speech eliminates symptoms of gastroesophageal reflux and resolves regurgitation associated prosthesis erosion. Although nearly all patients are satisfied with outcome, there is a high incidence of postfundoplication bloating and hyperflatulence that may be life limiting. Poor quality tracheoesophageal speech should not be used as an indication for antireflux surgery.

Management of long-term failure after colon interposition for benign disease.

PURPOSE: To assess causes and treatment of late failures of colon interposition. METHODS: We reviewed the charts of 6 patients who underwent one or more revisions of a colonic interposition at a mean of 16 years after colon interposition (CI). RESULTS: Symptoms of problems with the CI were dysphagia (67%), regurgitation (67%), pneumonia (40%), and chest pain (33%). Findings that accounted for failure were colonic redundancy (67%), and gastrocolonic reflux (50%). Approach was resection of redundant colon or management of reflux. Four patients underwent segmental resection of the colon preserving blood supply. Three patients had gastric resection or diversion of bile and acid for management of reflux. Treatment was successful in all patients. CONCLUSION: Late failure of colon interposition is secondary to conduit redundancy and severe reflux. Resection of redundant colon will correct colonic redundancy. Gastric resection or diversion of bile and acid corrects gastrocolonic reflux.

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.