Safety and effectiveness of REALIZE adjustable gastric band: 5-year prospective study.

BACKGROUND: The long-term safety results of the REALIZE (Ethicon Endo-Surgery, Inc., Cincinnati, OH) adjustable gastric band collected in this prospective, multicenter study in patients with morbid obesity are presented. OBJECTIVES: To determine the reoperation rate, including band revisions, replacements, and explants, resulting from a serious adverse device-related event through years 4 and 5. Various efficacy measures were also assessed as secondary objectives. SETTING: Nine academic and/or private institutions. METHODS: The participating institutions enrolled 303 patients, who were then assessed on an annual basis, with 231 patients completing 5 years of follow-up. The study parameters included reoperation rates, changes in percentage of excess weight loss (%EWL), and changes in body mass index (BMI), as well as parameters of diabetes and dyslipidemia. Quality of life was assessed using the Short Form (SF)-36 and the Impact of Weight on Quality of Life-Lite questionnaires. RESULTS: The reoperation rate due to a serious adverse event in this population at 5 years after implantation with the REALIZE gastric band was 8.9%. The most common serious adverse event was band slippage, which affected 6.9% of the study population. The mean %EWL was 35.6% ± 26.84%, and the decrease in mean BMI was -7.01 ± 5.45 kg/m2 at 5 years. Patients experienced improvements in mean glycated hemoglobin and serum lipid levels, in addition to improvements in the quality of life measures. CONCLUSION: No new safety concerns were identified during the 5 years of follow-up. Although the results of this study did not meet the predefined safety criteria of 8% or less, the safety profile and long-term effectiveness observed in this study are consistent with those in the current literature.

Laparoscopic sleeve gastrectomy: a retrospective review of 1- and 2-year results.

INTRODUCTION: Recently, laparoscopic sleeve gastrectomy (LSG) has been added as a surgical treatment for obesity. We report our 1- and 2-year results with LSG. METHODS: From September 2005, we have performed 247 LSGs. We retrospectively reviewed our 1- and 2-year data to assess weight loss, body mass index (BMI), percentage excess weight loss (%EWL), length of stay (LOS), complications, and resolution of diabetes. RESULTS: A total of 40 patients were eligible for follow-up at 2 years, and 157 patients were eligible for follow-up at 1 year. Data was available on 33/40 patients for 2 years and 131/157 patients for 1 year. Initial mean age, mean weight, and mean BMI for 1-year data were 43.2 years, 270.8 lb, and 44.3 kg/m(2), respectively. Initial mean age, mean weight, and mean BMI for 2-year data were 41.4 years, 273.3 lb, and 45.1 kg/m(2), respectively. Mean weight loss, BMI, and %EWL, for patients at 1 year and 2 years were 89.3 lb, 29.6 kg/m(2), and 78% and 87.5 lb, 30.0 kg/m(2), and 75%, respectively. There was no significant difference between use of 46-Fr, 40-Fr, and 36-Fr bougie with respect to weight loss, BMI or %EWL. Likewise, there was no difference seen between use of 7-cm versus 4-cm antral pouch. Mean LOS for both groups was 1.1 days. A total of 12 complications occurred, including one (0.6%) death and two (1.3%) leaks. A total of 39 patients were diabetic, of whom 32 (82%) were cured of diabetes and the remaining 7 patients had their medications decreased. CONCLUSION: Our results show that LSG is a safe and effective weight-loss procedure with results similar to those of gastric bypass. Additional long-term studies are still needed to accurately compare laparoscopic sleeve gastrectomy with gastric bypass and/or gastric banding.

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.

A Vertically Placed Clip for Weight Loss: a 39-Month Pilot Study.

BACKGROUND: Morbid obesity remains one of society's significant medical dilemmas. It is rapidly worsening and expected to affect 35% of the US population by the year 2020. Common current bariatric procedures exist and include, but not limited to, the adjustable gastric band, gastric bypass, and the sleeve gastrectomy. Although beneficial to morbidly obese patients, they also alter the patient's anatomy and involve resections, or require maintenance. The goal of the trial is to show a new minimally invasive vertical gastric clip technique that produces significant weight loss but requires no resection, no change in anatomy, and is reversible. METHODS: From November 2012 to February 2016, prospective collected data from 117 patients was included in the gastric clip trial. The clip consists of a silicone-covered titanium backbone with an inferior hinged opening that separates a medial lumen from an excluded lateral gastric pouch. The inferior opening allows the gastric juices to empty from the fundus and the body of the stomach into the distal antrum. RESULTS: Weight loss and comorbidities were evaluated among 117 patients over a 39-month period. 66.7% excess weight loss was seen with minimal adverse events. Average length of surgery was 69 min. Average length of stay was 1.3 days. Fifteen of the originally implanted clips were electively removed based on the original protocol, and the other two were removed for displacement of the device. CONCLUSION: The vertical, gastric clip trial has shown that excellent weight loss can be achieved without some of the complications seen with historical bariatric procedures. This clip is placed without requiring stapling, resection, malabsorption, change in anatomy, or maintenance. It is also easily reversible.

Laparoscopic management as the initial treatment of acute small bowel obstruction.

OBJECTIVES: We prospectively evaluated our experience with laparoscopic management of acute small bowel obstruction (SBO). METHODS: The study group included all patients requiring surgical intervention based on complete mechanical SBO by clinical assessment or who had failed conservative management. Patients with malignant causes were excluded. Experienced laparoscopic surgeons performed all operations. RESULTS: Between January 1998 to January 2003, 61 patients required operative intervention for acute SBO. Causes included adhesions, internal hernia, incarcerated incisional hernia, and inflammatory bowel disease. Laparoscopic techniques (LAP) alone were successfully used to complete 41 cases (67%). Twenty patients (33%) were converted (CONV) to either mini-laparotomy [7 patients (35%)] or standard midline laparotomy [13 patients (65%)]. A single band was identified in 25 patients (41%). Complications occurred in both groups. CONCLUSIONS: We believe all patients requiring surgery in the setting of acute small bowel obstruction should undergo a laparoscopic approach initially. By specifically identifying those patients with a single band as the cause of obstruction, a significant number of patients will be spared a large laparotomy incision. Conversion should not be viewed as failure, but rather, a sometimes necessary step in the optimal management of these patients.

International Sleeve Gastrectomy Expert Panel Consensus Statement: best practice guidelines based on experience of >12,000 cases.

BACKGROUND: Laparoscopic sleeve gastrectomy (LSG) is an emerging surgical approach, but 1 that has seen a surge in popularity because of its perceived technical simplicity, feasibility, and good outcomes. An international expert panel was convened in Coral Gables, Florida on March 25 and 26, 2011, with the purpose of providing best practice guidelines through consensus regarding the performance of LSG. The panel comprised 24 centers and represented 11 countries, spanning all major regions of the world and all 6 populated continents, with a collective experience of >12,000 cases. It was thought prudent to hold an expert consensus meeting of some of the surgeons across the globe who have performed the largest volume of cases to discuss and provide consensus on the indications, contraindications, and procedural aspects of LSG. The panel undertook this consensus effort to help the surgical community improve the efficacy, lower the complication rates, and move toward adoption of standardized techniques and measures. The meeting took place at on-site meeting facilities, Biltmore Hotel, Coral Gables, Florida. METHODS: Expert panelists were invited to participate according to their publications, knowledge and experience, and identification as surgeons who had performed >500 cases. The topics for consensus encompassed patient selection, contraindications, surgical technique, and the prevention and management of complications. The responses were calculated and defined as achieving consensus (≥70% agreement) or no consensus (<70% agreement). RESULTS: Full consensus was obtained for the essential aspects of the indications and contraindications, surgical technique, management, and prevention of complications. Consensus was achieved for 69 key questions. CONCLUSION: The present consensus report represents the best practice guidelines for the performance of LSG, with recommendations in the 3 aforementioned areas. This report and its findings support a first effort toward the standardization of techniques and adoption of working recommendations formulated according to expert experience.

Failed restrictive surgery: is sleeve gastrectomy a good revisional procedure?

The aim of this study is to evaluate the safety and efficacy of converting failed restrictive procedures such as laparoscopic adjustable gastric banding (LAGB), non-adjustable gastric banding (NAGB), and vertical banded gastroplasty (VBG) to laparoscopic sleeve gastrectomy (LSG). A prospective database was maintained of 32 patients who failed restrictive procedures. Twenty-six patients failed LAGB, three patients failed NAGB, one of which was performed open, and three patients failed VBG. These patients were converted to LSG between January 2006 and May 2010. Post-conversion outcomes, BMI, and excess weight loss (EWL) were recorded. Four patients were excluded from the weight loss statistical data secondary to short follow-up (less than 6 months since conversion); however, these patients were included in the overall number of cases and in the discussion of complications. Causes of failed restrictive procedures in our series include inadequate weight loss, 15 (47%); weight gain, six (19%); slippage, five (16%); esophageal dilatation, one (3%); unhappy with device, one (3%); tear of silastic ring, one (3%); infection, one (3%), gastrogastric fistula with VBG and weight gain, one (3%); and intractable nausea and vomiting, one (3%). The average hospital stay was 1.5 days (range, 1-3). The average length of follow-up was 26 months. The mean pre-conversion BMI was 42.69, post-conversion to SG mean BMI was 33.3, mean EWL pre-conversion was 10%, and post-conversion mean EWL was 60%. There was no mortality, no conversion to open, and there was one complication, a contained leak resolved by antibiotic treatment. Conversion to LSG from a prior restrictive procedure may be a feasible and acceptable alternative for patients. Average EWL was 60% at an average of 26 months.

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.

Long-term survival after laparoscopic colon resection for cancer: complete five-year follow-up.

PURPOSE: The role of laparoscopic surgery in the cure of colorectal cancer is controversial. The aim of this study was to evaluate long-term survival after curative, laparoscopic resection of colorectal cancer. Specifically, we wanted to review those patients who now had complete five-year follow-up. METHODS: One hundred two consecutive patients (March 1991 to March 1996) underwent laparoscopic colon resections for cancer at one institution and now have complete five-year survival data. Charts were retrospectively reviewed and results compared with conventional surgery, i.e., open colectomy at our institution, and with the National Cancer Data Base during a similar time period. RESULTS: Fifty-nine male and 43 female patients with an average age of 70 (range, 34-92) years made up the study. Complications occurred in 23 percent of patients, and one patient died (1 percent). Forty-four laparoscopic right colectomies, 2 transverse colectomies, 36 laparoscopic left or sigmoid colectomies, 15 laparoscopic low anterior resections, and 5 laparoscopic abdominoperineal resections were performed. The average number of lymph nodes harvested was 6.6 +/- 0.61 (range, 0-22). Eight cases (7.8 percent) were "converted to open"; i.e., the typical 6-cm extraction site was lengthened to complete mobilization, devascularization, resection, or anastomosis, or a separate incision was required to complete the procedure. There was one extraction-site recurrence and one port-site recurrence; both occurred before the routine use of plastic-sleeve wound protection. The mean follow-up for laparoscopic colon resection patients was 64.4 +/- 2.8 (range, 1-111) months. According to the TNM classification system, 27 patients had Stage I cancer, 37 had Stage II, 23 had Stage III, and 15 had Stage IV. Similar five-year survival rates for laparoscopic and conventional surgery for cancer were noted. The five-year relative survival rates in the laparoscopic colon resection group were 73 percent for Stage I, 61 percent for Stage II, 55 percent for Stage III, and 0 percent for Stage IV. The five-year relative survival rates for the open colectomy and National Cancer Data Base groups were 75 and 70 percent, respectively, for Stage I, 65 and 60 percent for Stage II, 46 and 44 percent for Stage III, and 11 and 7 percent for Stage IV. CONCLUSIONS: Laparoscopic colon resection for cancer is safe and feasible in a private setting. Our data suggest that long-term survival after laparoscopic colon resection for cancer is similar to survival after conventional surgery. Prospective, randomized trials presently under way will likely confirm these results.