Prospective, randomized, multicenter study evaluating safety and efficacy of intragastric dual-balloon in obesity.

BACKGROUND: Intragastric balloons are designed to occupy space within the stomach and induce satiety. The present study evaluated the safety and efficacy of an intragastric dual balloon as an adjunct to diet and exercise in obese patients compared with diet and exercise alone. METHODS: After approval from the institutional review board, patients provided written consent and were randomized to the treatment group (TG) or control group (CG) in a 2:1 ratio. Three sites randomized a total of 30 patients to the TG (n = 21) or CG (n = 9). Patients randomized to the TG underwent endoscopic placement of the dual balloon. Both groups received similar diet and exercise counseling. After 24 weeks, the device was removed. Patient weight, adverse events, and quality of life data were evaluated throughout the 48-week study duration. RESULTS: Our patient population included 26 women and 4 men aged 26-59 years. At 24 weeks, the mean excess weight loss in the TG and CG was 31.8% ± 21.3% and 18.3% ± 20.9%, respectively (P = .1371). At 48 weeks, 24 weeks after device removal, the TG maintained 64% of their weight loss. No deaths, unanticipated adverse effects, early removals, balloon deflations, or balloon migrations occurred. In the TG, 4 patients were readmitted for severe nausea, 1 had asymptomatic gastritis at balloon removal, and 1 patient experienced transient hypoxia during device removal. CONCLUSION: In the present small study, the dual balloon proved easy to use, was associated with a trend toward greater weight loss than the CG, and demonstrated a good safety profile.

Analysis of weight loss after bariatric surgery using mixed-effects linear modeling.

BACKGROUND: The standard analysis of bariatric surgery weight outcomes data (using t tests) is well known. However, these uncontrolled comparisons may yield misleading results and limit the range of research questions. The aim of the study was to develop a valid approach to the longitudinal analysis of weight loss outcomes after bariatric surgery using multivariable mixed models. This study has a multi-institutional setting. METHODS: We developed a mixed-effects model to examine weight after gastric bypass surgery while controlling for several independent variables: gender, anastomotic technique, age, race, initial weight, height, and institution. We contrasted this approach with traditional uncontrolled analyses using percent excess weight loss (%EWL). RESULTS: One thousand one hundred sixty-eight gastric bypass procedures were performed between 2000 and 2006. The average %EWL at 1, 2, and 3 years was 71%, 79%, and 76%, respectively. Using weight as the outcome variable, initial weight and gender were the only independent predictors of outcome (p<0.001). %EWL was substantially less accurate than weight as an outcome measure in multivariable modeling. Including initial weight and height as separate independent variables yielded a more accurate model than using initial body mass index. In a traditional uncontrolled analysis, average %EWL was higher in women than men. However, average weight loss was lower, not higher, in women (p<0.001) in our multivariable mixed model. Height, surgical technique, race and age did not independently predict weight loss. CONCLUSIONS: Multivariable mixed models provide more accurate analyses of weight loss surgery than traditional methods and should be used in studies that examine repeated measurements.

Sexual dysfunction is common in the morbidly obese male and improves after gastric bypass surgery.

BACKGROUND: There has been limited research examining the mechanisms and epidemiology of sexual dysfunction in the morbidly obese. Our objectives were to measure sexual function in the morbidly obese man before and after substantial weight loss induced by gastric bypass surgery. STUDY DESIGN: All male patients in undergoing gastric bypass completed the Brief Male Sexual Function Inventory (BSFI) before and after operation. BSFI scores were also compared with published normative controls and analyzed for predictors of change. Mixed models were created to control for age, diabetes, and hypertension. RESULTS: Ninety-seven men with a mean age of 48 years (range 19 to 75 years) and mean body mass index of 51 kg/m(2) (range 36 to 89 kg/m(2)) underwent gastric bypass surgery. On average, preoperative morbidly obese patients reported a substantially greater degree of sexual dysfunction than did published reference controls in all domains, p < 0.001. Increasing weight independently predicted lower domain scores. Mean postoperative followup length was 19 months (range 6 to 45 months). On average, BSFI scores improved from preoperative levels by bivariate analysis in all categories (means+/-SE): sexual drive (range 0 to 8), 3.9+/-0.3 to 5.3+/-0.3; erectile function (range 0 to 12), 6.4+/-0.5 to 8.9+/-0.5; ejaculatory function (range 0 to 8), 4.9+/-0.4 to 6.3+/-0.4; problem assessment (range 0 to 12), 7.4+/-0.5 to 9.6+/-0.5; and sexual satisfaction (range 0 to 4), 1.6+/-0.2 to 2.3+/-0.2; all p < 0.01. On multivariable analysis, the amount of weight loss independently predicted the degree of improvement in all BSFI domains, p < 0.05. After an average 67% excess weight loss, BSFI scores in postoperative gastric bypass patients approached those of the reference controls. CONCLUSIONS: Men with morbid obesity commonly suffer from profound, but reversible sexual dysfunction.

Continuous intravenous heparin infusion prevents peri-operative thromboembolic events in bariatric surgery patients.

BACKGROUND: The pharmacokinetics of subcutaneous heparin administration in the obese patient are unpredictable. Peak levels are slowly reached and the effects are not rapidly reversible. Low-dose, continuous, intravenous heparin is easily reversed, is more efficacious and is cost-effective. METHODS: From November 2000 until July 2005, 822 consecutive patients were administered continuous intravenous unfractionated heparin at 400 U/hr (9,600 U/day) starting in the preoperative holding area and maintained until discharge. All clinically significant events were documented. RESULTS: 634 laparoscopic gastric bypass, 10 revisions and 188 Lap-Band procedures were performed. The mean age was 43+/-11 years (15-74) and mean BMI was 45.2+/-7.1 (30-86). There was only one (0.12%) clinically evident thromboembolic event in the entire cohort (after a gastric bypass). Anti-Xa levels and prothrombin time were followed in a group of 40 patients and were found to be normal in all. Bleeding that required transfusion occurred in 1.3% of patients. In 41 patients (5%), heparin therapy was terminated or temporarily held due to need for extensive adhesiolysis or acute drop in hematocrit, with-or-without other evidence of postoperative bleeding. Average estimated blood loss during surgery was 36 cc (5-500 cc). One patient was inadvertently administered excessive doses of heparin due to a pump error without significant sequelae. CONCLUSIONS: Continuous low-dose intravenous heparin therapy is associated with an extremely low incidence of thromboembolic events and a low risk for perioperative hemorrhage. Intravenous heparin also has the benefits of being inexpensive and rapidly reversible.

The orientation of the antecolic Roux limb markedly affects the incidence of internal hernias after laparoscopic gastric bypass.

BACKGROUND: Internal herniation of the bowel may be a late complication after the laparoscopic Roux-en-Y gastric bypass (RYGBP). A seemingly minor change in technique is described that significantly prevents herniation behind the Roux limb mesentery. We hypothesized that internal hernias behind the Roux limb mesentery occur more frequently when the Roux limb is oriented such that the distal tip is toward the lesser curvature of the gastric pouch with the bowel then curving to the patient's left, compared with the opposite orientation. METHODS: A retrospective chart review was performed of our prospectively collected database. A change in surgical technique occurred June 2003, in an attempt to reduce internal hernia formation. We compared 200 consecutive antecolic left-oriented RYGBP operations performed immediately previous to June 2003 (Group A) with 200 consecutive antecolic right-oriented RYGBP operations performed after June 2003 (Group B). RESULTS: There was an 9.0% rate of internal hernia formation in Group A (18/200) and a 0.5% rate of internal hernia formation in Group B. Internal hernias were repaired an average of 1.2 years after surgery (range 4-30 months, median 14.3 months). The average length of follow-up was 2.1 and 1.6 years in Groups A and B, respectively. All herniations were behind the Roux limb mesentery. The difference in hernia formation after the change in technique was significant (P<0.005). CONCLUSIONS: With a simple change in technique, the incidence of internal herniation behind the Roux limb mesentery may be significantly reduced or eliminated.

Bariatric surgery in patients older than 65 years is safe and effective.

BACKGROUND: To review the short-term safety and efficacy of the laparoscopic adjustable gastric band (LAGB) and laparoscopic gastric bypass (GBP) in patients older than 65 years. METHODS: A single-institution review of all bariatric procedures was performed. RESULTS: Twenty-seven patients were identified. Of the 27 patients, 13 underwent primary GBP and 14 underwent LAGB placement. The average age was 68.1 +/- 2 years (range 65-73). The average follow-up for the GBP group and LAGB group was 9.3 months (range 1-21) and 19.6 months (range 4-31), respectively. One minor (stricture) complication and zero major complications occurred in the GBP group. In the LAGB group, one minor complication (port fracture) and one major complication (total weight loss failure requiring conversion to GBP) occurred. The percentage of excess weight loss at 1 year for the GBP group was 71%. At 1 and 2 years, it was 32% and 35%, respectively, for the LAGB group. Only in the GBP group did patients have a significant decrease in medication use and in the number of comorbidities. Quality-of-life measurements improved equally after both procedures. Weight loss was no different after GBP surgery regardless of age, but older LAGB patients had a 12% decrease in the expected excess weight lost (P < 0.05). CONCLUSION: Bariatric surgery can be performed with acceptable safety, excellent weight loss, resolution of comorbidities, and significant improvement in quality of life in patients older than 65 years. The GBP seems to be as safe as, and more effective than, the LAGB in this age group.

Superior mesenteric artery syndrome after laparoscopic Roux-en-Y gastric bypass for morbid obesity.

Gastrointestinal obstructive complications after laparoscopic Roux-en-Y gastric bypass (LRYGBP) are not uncommon. Their usual causes are strictures, internal hernias and adhesions. Superior mesenteric artery (SMA) syndrome is a rare disorder caused by compression of the third portion of the duodenum by the SMA that can occur after rapid weight loss. This has been reported in patients with scoliosis, burns, immobilization in body casts, and idiopathic weight loss. SMA syndrome following bariatric surgery has not been reported. We present 3 cases of SMA syndrome after LRYGBP and extensive weight loss. Two patients underwent laparoscopic duodenojejunostomy and the third patient was treated with intravenous hyperalimentation. All three are symptom free at 4-18 months follow-up. The diagnosis of SMA syndrome should be considered in bariatric surgery patients with rapid weight loss who develop atypical, recurrent obstructive symptoms not attributable to other common causes.