Moises Jacobs

Safety and effectiveness of Realize adjustable gastric band: 3-year prospective study in the United States

BACKGROUND The effectiveness and safety of bariatric surgery using laparoscopic adjustable gastric bands have been demonstrated in numerous published studies. We present the results of the first U.S. multicenter trial of the Realize adjustable gastric band, a laparoscopic adjustable gastric band previously available only outside the United States as the Swedish adjustable gastric band. METHODS A total of 405 morbidly obese patients were screened at 12 different centers from May to November 2003 to participate in a prospective, single-arm study of the safety and effectiveness of the laparoscopically implanted Realize band. Changes in excess body weight, the parameters of diabetes and dyslipidemia, and the incidence of complications were assessed at 3 years of follow-up. RESULTS Of the 405 patients, 276 (78.3% women and 61.2% white) qualified for the study. The average age was 38.6 + or - 9.4 years (range 18-61), and the preoperative body mass index was 44.5 + or - 4.7 kg/m(2). The mean hospital stay was 1.2 + or - 1.3 days. At 3 years, the average excess weight loss was 41.1% + or - 25.1% or a decrease in the body mass index of 8.2 kg/m(2) (18.6%) (P < .001). In diabetic patients with a baseline elevated hemoglobin A(1)c level, the level decreased by 1% (P < .001). The total cholesterol, low-density lipoprotein cholesterol, and triglycerides decreased by 9%, 16%, and 50%, respectively (P < .001), and the high-density lipoprotein cholesterol increased by 25% (P < .001) in patients with abnormal baseline values. One patient required conversion to an open surgical technique. No 30-day mortality occurred. The complication frequencies were generally low and included esophageal dysmotility in 0.4%, late balloon failure in 0.4%, band erosion in 0.4%, slippage in 3.3%, esophageal dilation in 3.3%, pouch dilation in 3.6%, catheter kinking in 1.1%, port displacement in 2.5%, and port disconnection in 4.3%. Reoperations were required in 15.2% of the patients and involved 2 band replacements, 9 band revisions, 5 port replacements, 22 port revisions, and 4 explants. CONCLUSION The results of our study have shown that the Realize adjustable gastric band is safe and effective in a diverse U.S. population of morbidly obese patients. Significant weight loss was achieved throughout the 3 years of follow-up, with corresponding improvements in the indicators of diabetes and dyslipidemia.

Use of surgisis mesh in laparoscopic repair of hiatal hernias.

Background Breakdown of the crural closure is a frequent reason for failure of antireflux surgical procedures. This retrospective study aimed to determine the effectiveness of using absorbable mesh in preventing recurrence of hiatal hernia after posterior cruroplasty. Design Comparative retrospective analysis. Method The charts of 220 adults who underwent antireflux surgery with posterior cruroplasty between 1997 and 2005 were retrospectively reviewed. Patients were divided into 2 groups: posterior cruroplasty+absorbable mesh reinforcement (n=127) and posterior cruroplasty alone (n=93). Symptomatic outcome was assessed by telephone interview in 92 patients (72%) in the mesh group at a median of 3.2 years postoperatively and 59 patients (63%) in the no mesh group of men studied at a median of 3.8 years postoperatively. Main Outcome Measures Incidence of recurrence and persistent symptoms. Results In the mesh group, 74/92 (80%) patients remained asymptomatic at a median of 3.2 years postoperatively. Of these patients, 31 underwent either an upper endoscopy or an upper gastrointestinal (UGI) series; none had recurrence of hiatal hernia. Of the 18 symptomatic patients, 13 underwent an upper endoscopy or an UGI series to determine the etiology of symptoms; 3 recurrences were confirmed for a 3.3% overall proven recurrence rate. In the no mesh group, 26/59 (44%) patients were symptomatic. Of these, 18 underwent either an upper endoscopy or an UGI series. Recurrence of hernia was confirmed in 12 patients for a 20% overall proven recurrence rate. There were no instances of mesh infection or erosion. Conclusions Symptomatic recurrence rates of hiatal hernia after antireflux surgery vary. Recurrence of a hiatal hernia may or may not lead to symptoms. This retrospective analysis demonstrates that absorbable mesh is safe and may lead to a significant reduction in the incidence of symptomatic recurrent hiatal hernia.