Safety and efficacy of bariatric surgery in patients with advanced fibrosis.

BACKGROUND: Bariatric surgery is performed safely in non-alcoholic fatty liver disease (NAFLD) patients with minimal fibrosis (stage 1-2). However, the safety and potential benefits of bariatric surgery for NAFLD with advanced fibrosis (stage 3-4) remain unclear. This study was designed to compare the safety and efficacy of bariatric surgery in patients with biopsy proven advanced fibrosis to those with minimal fibrosis. METHODS: All patients who underwent bariatric surgery between 2005 and 2014 and had evidence of NAFLD with fibrosis score 3-4 (advanced fibrosis) based on the staging system defined by Kleiner et al. on intraoperative liver biopsy were included and compared with patients who had fibrosis score 1-2 (minimal fibrosis). The groups were compared for length of hospital stay after bariatric surgery and incidence of postoperative complications over a follow-up period of 1 year. An improvement in hepatic function tests before and 1 year after surgery was used as a parameter to evaluate for NAFLD improvement. RESULTS: Ninety-nine patients with F3-4 (group 1) and 198 patients with F1-2 (group 2) were included. Mean age (51.9 vs 50.1 years) and body mass index (46.4 vs 46.5 kg m-2) were similar in the two groups. Median serum aspartate aminotransferase (43 vs 30 U l-1; normal 10-40 U l-1) and alanine aminotransferase (40.5 vs 34 U l-1; normal 10-50 U l-1) were significantly higher in group 1 and improved 1 year after surgery. Median length of hospital stay after surgery was higher in group 1 than that in group 2 (4 days vs 3 days; P-value=0.002). The proportion of patients developing postoperative complications over 1 year was similar in both groups (36.4% vs 32.8%; P-value=0.54). CONCLUSIONS: Advanced fibrosis does not increase the risk of developing postoperative complications in medically optimized patients undergoing bariatric surgery. Improvement in serum transaminase levels suggests a reduction in hepatic necroinflammatory activity following bariatric surgery.

Outcomes of concomitant ventral hernia repair performed during bariatric surgery.

BACKGROUND: Currently there is no consensus on management of ventral hernias encountered during bariatric surgery (BS). This study aims to evaluate the incidence and outcomes of concomitant ventral hernia repair (VHR) during BS at our institution. METHODS: Patients who had concomitant VHR during BS from 2004 to 2015 were identified. Data collected included baseline demographics, comorbidities, perioperative parameters, surgical approach and postoperative outcomes. RESULTS: A total of 159 patients underwent concomitant VHR during the study period at the time of BS. One hundred and one (64 %) patients were female; median age was 53 years (IQR 45.0-60.3) and median BMI was 48.2 kg/m2 (IQR 41.6-54.1). Comorbidities included: hypertension (n = 124, 78 %), type 2 diabetes (n = 103, 65 %), hyperlipidemia (n = 100, 63 %), obstructive sleep apnea (n = 98, 62 %) and reflux disease (n = 54, 34 %). Out of 159 patients, 41 patients (26 %) had a prior VHR. Out of 103 patients, 69 patients (67 %) had a previous abdominal surgery. Of the concomitant VHR, 144 (91 %) were completed laparoscopically, 12 (7 %) patients were converted to open surgery and 3 (2 %) patients underwent primary open procedures. Technique included primary suture closure in 115 (72 %) and mesh repair in 44. Early postoperative complications (<30 days) were reported in 16 (10 %) patients, with superficial wound infection (n = 9), bowel obstruction (n = 2), marginal ulcer (n = 2), DVT (n = 1) and pneumonia (n = 1). Hernia recurrence was reported in 3 patients (2 %) in the early post-op period and in 40 patients (25 %) as a late (>30 days) complication. Surgery for recurrent hernia was performed in 31/42 patients during follow-up. At 12-month follow-up, median BMI and % excess weight loss were 34.2 kg/m2 (IQR 29.5-40.9) and 59.6 % (IQR 44.9-74.8 %), respectively. CONCLUSION: Ventral hernia is a common finding in patients undergoing BS. Both primary suture repair and mesh repair result in acceptable results, both in terms of recurrence and perioperative complications.

Gastric bypass surgery is protective from high-fat diet-induced non-alcoholic fatty liver disease and hepatic endoplasmic reticulum stress.

AIM: High-fat diets are known to contribute to the development of obesity and related co-morbidities including non-alcoholic fatty liver disease (NAFLD). The accumulation of hepatic lipid may increase endoplasmic reticulum (ER) stress and contribute to non-alcoholic steatohepatitis and metabolic disease. We hypothesized that bariatric surgery would counter the effects of a high-fat diet (HFD) on obesity-associated NAFLD. METHODS: Sixteen of 24 male Sprague Dawley rats were randomized to Sham (N = 8) or Roux-en-Y gastric bypass (RYGB) surgery (N = 8) and compared to Lean controls (N = 8). Obese rats were maintained on a HFD throughout the study. Insulin resistance (HOMA-IR), and hepatic steatosis, triglyceride accumulation, ER stress and apoptosis were assessed at 90 days post-surgery. RESULTS: Despite eating a HFD for 90 days post-surgery, the RYGB group lost weight (-20.7 ± 6%, P < 0.01) and improved insulin sensitivity (P < 0.05) compared to Sham. These results occurred with no change in food intake between groups. Hepatic steatosis and ER stress, specifically glucose-regulated protein-78 (Grp78, P < 0.001), X-box binding protein-1 (XBP-1) and spliced XBP-1 (P < 0.01), and fibroblast growth factor 21 (FGF21) gene expression, were normalized in the RYGB group compared to both Sham and Lean controls. Significant TUNEL staining in liver sections from the Obese Sham group, indicative of accelerated cell death, was absent in the RYGB and Lean control groups. Additionally, fasting plasma glucagon like peptide-1 was increased in RYGB compared to Sham (P < 0.02). CONCLUSION: These data suggest that in obese rats, RYGB surgery protects the liver against HFD-induced fatty liver disease by attenuating ER stress and excess apoptosis.

How safe is metabolic/diabetes surgery?

Although recent studies have shown the impressive antidiabetic effects of laparoscopic Roux-en-Y gastric bypass (LRYGB), the safety profile of metabolic/diabetes surgery has been a matter of concern among patients and physicians. Data on patients with type 2 diabetes who underwent LRYGB or one of seven other procedures between January 2007 and December 2012 were retrieved from the American College of Surgeons National Surgical Quality Improvement Program database and compared. Of the 66 678 patients included, 16 509 underwent LRYGB. The composite complication rate of 3.4% after LRYGB was similar to those of laparoscopic cholecystectomy and hysterectomy. The mortality rate for LRYGB (0.3%) was similar to that of knee arthroplasty. Patients who underwent LRYGB had significantly better short-term outcomes in all examined variables than patients who underwent coronary bypass, infra-inguinal revascularization and laparoscopic colectomy. In conclusion, LRYGB can be considered a safe procedure in people with diabetes, with similar short-term morbidity to that of common procedures such as cholecystectomy and appendectomy and a mortality rate similar to that of knee arthroplasty. The mortality risk for LRYGB is one-tenth that of cardiovascular surgery and earlier intervention with metabolic surgery to treat diabetes may eliminate the need for some later higher-risk procedures to treat diabetes complications.

Attenuated improvements in adiponectin and fat loss characterize type 2 diabetes non-remission status after bariatric surgery.

AIM: To identify the metabolic determinants of type 2 diabetes non-remission status after bariatric surgery at 12 and 24 months. METHODS: A total of 40 adults [mean ± sd body mass index 36 ± 3 kg/m(2) , age 48 ± 9 years, glycated haemoglobin (HbA1c) 9.7 ± 2%) undergoing bariatric surgery [Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)] were enrolled in the present study, the Surgical Treatment and Medication Potentially Eradicate Diabetes Efficiently (STAMPEDE) trial. Type 2 diabetes remission was defined as HbA1c <6.5% and fasting glucose <126 mg/dl (i.e. <7 mmol/l) without antidiabetic medication. Indices of insulin secretion and sensitivity were calculated from plasma glucose, insulin and C-peptide values during a 120-min mixed-meal tolerance test. Body fat, incretins (glucagon-like polypeptide-1, gastric inhibitory peptide, ghrelin) and adipokines [adiponectin, leptin, tumour necrosis factor-α, high-sensitivity C-reactive protein (hs-CRP)] were also assessed. RESULTS: At 24 months, 37 patients had available follow-up data (RYGB, n = 18; SG, n = 19). Bariatric surgery induced type 2 diabetes remission rates of 40 and 27% at 12 and 24 months, respectively. Total fat/abdominal fat loss, insulin secretion, insulin sensitivity and ß-cell function (C-peptide0-120 /glucose0-120 × Matsuda index) improved more in those with remission at 12 and 24 months than in those without remission. Incretin levels were unrelated to type 2 diabetes remission, but, compared with those without remission, hs-CRP decreased and adiponectin increased more in those with remission. Only baseline adiponectin level predicted lower HbA1c levels at 12 and 24 months, and elevated adiponectin correlated with enhanced ß-cell function, lower triglyceride levels and fat loss. CONCLUSIONS: Smaller rises in adiponectin level, a mediator of insulin action and adipose mass, characterize type 2 diabetes non-remission up to 2 years after bariatric surgery. Adjunctive strategies promoting greater fat loss and/or raising adiponectin may be key to achieving higher type 2 diabetes remission rates after bariatric surgery.

Improved acylated ghrelin suppression at 2 years in obese patients with type 2 diabetes: effects of bariatric surgery vs standard medical therapy.

OBJECTIVE: Roux-en-Y gastric bypass (RYGB) produces more durable glycemic control than sleeve gastrectomy (SG) or intensive medical therapy (IMT). However, the contribution of acylated ghrelin (AG), a gluco-regulatory/appetite hormone, to improve glucose metabolism and body composition in patients with type 2 diabetes (T2D) following RYGB is unknown. DESIGN: STAMPEDE (Surgical Treatment and Medication Potentially Eradicate Diabetes Efficiently) was a prospective, randomized controlled trial. SUBJECTS: Fifty-three (body mass index: 36±3 kg m(-2), age: 49±9 years) poorly controlled patients with T2D (HbA1c (glycated hemoglobin): 9.7±2%) were randomized to IMT, IMT+RYGB or IMT+SG and underwent a mixed-meal tolerance test at baseline, 12, and 24 months for evaluation of AG suppression (postprandial minus fasting) and beta-cell function (oral disposition index; glucose-stimulated insulin secretion × Matsuda index). Total/android body fat (dual-energy X-ray absorptiometry) was also assessed. RESULTS: RYGB and SG reduced body fat comparably (15-23 kg) at 12 and 24 months, whereas IMT had no effect. Beta-cell function increased 5.8-fold in RYGB and was greater than IMT at 24 months (P<0.001). However, there was no difference in insulin secretion between SG vs IMT at 24 months (P=0.32). Fasting AG was reduced fourfold following SG (P<0.01) and did not change with RYGB or IMT at 24 months. AG suppression improved more following RYGB than SG or IMT at 24 months (P=0.01 vs SG, P=0.07 vs IMT). At 24 months, AG suppression was associated with increased postprandial glucagon-like peptide-1 (r=-0.32, P<0.02) and decreased android fat (r=0.38; P<0.006). CONCLUSIONS: Enhanced AG suppression persists for up to 2 years after RYGB, and this effect is associated with decreased android obesity and improved insulin secretion. Together, these findings suggest that AG suppression is partly responsible for the improved glucose control after RYGB surgery.

Complete endoscopic/transgastric retrieval of eroded gastric band: description of a novel technique and review of the literature.

Complications of laparoscopic adjustable gastric banding (LAGB) include band slippage, material infection, and band erosion. Band erosion can lead to chronic infection, obstruction, delayed perforation, and ineffectiveness; therefore, removal is indicated. A myriad of approaches exist for band removal and many authors have described novel techniques. A minimally invasive approach, including laparoscopic or endoscopic assistance, is favored given the reduction of postoperative complications compared with laparotomy. We present a novel approach to band retrieval following partial erosion involving a complete endoscopic/transgastric technique. Perioperative management and a review of the literature also are described.

Bariatric surgery for treatment of obesity.

This article focuses on recent trends and outcomes of bariatric surgery. The outcomes discussed include perioperative morbidity and mortality, weight loss, long-term complications and the impact of bariatric surgery on comorbidities, cardiovascular risk and mortality.

A focus on surgical preoperative evaluation of the bariatric patient--the Cleveland Clinic protocol and review of the literature.

Bariatric surgery is well established as a safe and effective treatment for morbid obesity and related metabolic diseases. As an elective procedure, it is critical that individuals considering bariatric surgery should be carefully selected, extensively evaluated, and optimized in order to achieve optimal outcomes. This patient population has unique and challenging issues, including an extensive range of potential medical, psychiatric, and psychological comorbidities, and often patients have unrealistic expectations of the surgery. Therefore, a multidisciplinary, comprehensive and timely assessment preoperatively is of great importance. Individual bariatric units utilise different preoperative patient evaluation protocols. There is at present no uniformly accepted or recommended practice. In this article we describe what we believe are the essential components of a preoperative bariatric surgery evaluation, with supporting evidence for each recommendation. We also present a protocol currently in practice at a high volume bariatric center of excellence; the Bariatric and Metabolic Institute in the Cleveland Clinic, Ohio.

Acute effects of gastric bypass versus gastric restrictive surgery on beta-cell function and insulinotropic hormones in severely obese patients with type 2 diabetes.

CONTEXT: Hyperglycemia resolves quickly after bariatric surgery, but the underlying mechanism and the most effective type of surgery remains unclear. OBJECTIVE: To examine glucose metabolism and beta-cell function in patients with type 2 diabetes mellitus (T2DM) after two types of bariatric intervention; Roux-en-Y gastric bypass (RYGB) and gastric restrictive (GR) surgery. DESIGN: Prospective, nonrandomized, repeated-measures, 4-week, longitudinal clinical trial. PATIENTS: In all, 16 T2DM patients (9 males and 7 females, 52+/-14 years, 47+/-9 kg m(-2), HbA1c 7.2+/-1.1%) undergoing either RYGB (N=9) or GR (N=7) surgery. OUTCOME MEASURES: Glucose, insulin secretion, insulin sensitivity at baseline, and 1 and 4 weeks post-surgery, using hyperglycemic clamps and C-peptide modeling kinetics; glucose, insulin secretion and gut-peptide responses to mixed meal tolerance test (MMTT) at baseline and 4 weeks post-surgery. RESULTS: At 1 week post-surgery, both groups experienced a similar weight loss and reduction in fasting glucose (P<0.01). However, insulin sensitivity increased only after RYGB, (P<0.05). At 4 weeks post-surgery, weight loss remained similar for both groups, but fasting glucose was normalized only after RYGB (95+/-3 mg 100 ml(-1)). Insulin sensitivity improved after RYGB (P<0.01) and did not change with GR, whereas the disposition index remained unchanged after RYGB and increased 30% after GR (P=0.10). The MMTT elicited a robust increase in insulin secretion, glucagon-like peptide-1 (GLP-1) levels and beta-cell sensitivity to glucose only after RYGB (P<0.05). CONCLUSION: RYGB provides a more rapid improvement in glucose regulation compared with GR. This improvement is accompanied by enhanced insulin sensitivity and beta-cell responsiveness to glucose, in part because of an incretin effect.

Percutaneous transesophageal gastrostomy (PTEG): a safe and effective technique for gastrointestinal decompression in malignant obstruction and massive ascites.

BACKGROUND: Enteral feeding and gastric decompression devices are common in critical, terminal, and chronically ill patients. Percutaneous transesophageal gastrostomy (PTEG) is a nonsurgical technique that creates an esophagostomy and allows enteral access in patients with a hostile abdomen, altered gastric anatomy, massive ascites, and carcinomatosis. We review our indications, technical experience, complications, and short- and long-term quality of life (QOL) in patients that underwent the PTEG procedure. METHODS: Patients were terminally ill from advanced cancer requiring gastrointestinal decompression or had hostile abdomens needing long-term feeding access. The procedure is carried out by inserting a rupture-free balloon (RFB) into the cervical esophagus and utilizing transcutaneous ultrasound to puncture the balloon. A guide wire is passed through the needle into the balloon, followed by a dilator and sheath. The in-dwelling catheter is inserted through the sheath, which exits the esophagus, and resides in the stomach. Proper placement is confirmed by fluoroscopy. RESULTS: From December 2003 to January 2006, 17 patients were treated with PTEG. Except for two patients, all of the patients had advanced metastatic cancer. Presenting symptoms were nausea, vomiting, and dysphagia. Average age was 62.8 years, with nine men. Placement was successful in 16 patients (94%). There were no major complications and three minor complications (17.6%). Minor complications included two esophageal leaks at the catheter site and one catheter dislodgement. Seven patients (41.2%) died within 1 month after the procedure from their preexisting medical conditions. All patients were capable of being discharged from the hospital with adequate enteral access and gastrointestinal decompression. CONCLUSIONS: PTEG is a safe and effective method of enteral feeding and decompression in patients that have contraindications to standard enteral access. Appropriate patient selection and timing of PTEG placement is crucial for optimum benefit.

New applications for endoscopy: the emerging field of endoluminal and transgastric bariatric surgery.

Endoluminal and transgastric procedures are evolving concepts that combine the skills and techniques of flexible endoscopy with minimally invasive surgery. Precisely how this technology and skill set will be applied in the field of general surgery is not yet known, but the treatment of obesity with an endoluminal or transgastric procedure holds great promise. As the demand for bariatric surgery increases, efforts will be directed toward developing less morbid and less costly treatment options that can provide substantial weight loss and resolution of comorbid conditions. Natural orifice bariatric procedures may include short-term weight loss in preparation for a definitive laparoscopic procedure, revisional procedures to reduce stoma or pouch size or repair fistulas, or primary therapy that provides durable weight loss. The latter application will undoubtedly appeal to patients and referring physicians if it can be performed as an outpatient procedure with significantly less morbidity than a laparoscopic procedure. Early preclinical and clinical work has been published in this area, but many technical obstacles must be overcome before a primary endoluminal or transgastric bariatric procedure can be offered. This article reviews the endoluminal and transgastric technology currently available, the endoluminal procedures currently performed, and the future of these technologies with respect to bariatric surgery.

Management of recurrent colorectal carcinoma.

BACKGROUND/OBJECTIVE: The records of patients treated for adenocarcinoma of the colon and rectum between 1 January 1988 and 31 December 1995 at Naval Medical Center San Diego were reviewed. Analysis was made of patients who developed recurrences after potentially definitive primary therapy. METHODS: A retrospective review of 410 patients diagnosed with colorectal cancer at our institution was conducted. The focus of this review was to identify patients with recurrent disease after curative initial procedures, and to determine how recurrences were detected and treated. Survival data for 48 patients undergoing various curative and palliative procedures, or no therapy, were generated. RESULTS: The decision to re-operate with curative intent was made after a multidisciplinary review of restaging studies. Laparoscopy was not used in this determination. Curative resection of recurrence confers increased survival over non-curative surgery and no surgery (P < 0.001). This is misleading because of patient selection; several patients undergo potentially curative surgery but are determined intraoperatively to best be palliated, or to have further surgery aborted. Analysis of results in patients undergoing potentially curative surgery vs. those undergoing planned palliation vs. those not operated reveals that these also provide significantly different outcomes (P < 0.003). CONCLUSIONS: Proper delineation of resectable lesions in patients with recurrent colorectal cancer contributes to better outcomes for them. That determination is difficult, and efforts are underway in our institution and elsewhere to better delineate which patients are optimal preoperatively. We consider multidisciplinary Tumor Board evaluation to be central to this process.

Treatment of varicose veins: proximal saphenofemoral ligation comparing adjunctive varicose phlebectomy with sclerotherapy at a military medical center.

There is no consensus as to the single best approach to the treatment of varicose veins. There has been a trend toward less invasive procedures to reduce the number of incisions and provide more selective ablation of varicosities. Ultimately, therapeutic decisions have depended on surgeon preference and the patient population. The active duty military population presents a unique challenge in the treatment of varicose veins. This mobile and active population requires a treatment method that provides maximum relief with the lowest possible morbidity and rapid recovery. The authors previously reported their experience with 104 patients who underwent saphenofemoral ligation combined with perforator point ligation and staged sclerotherapy. This group was compared to 103 patients who underwent saphenofemoral ligation, point perforator ligation, and stab avulsion phlebectomy as a single procedure. Follow-up for the sclerotherapy group included patient satisfaction surveys and documentation of recurrent varicosities. All ambulatory phlebectomy patients responded positively with respect to symptomatic and cosmetic results. Overall satisfaction was favorable and there was no significant difference in patient satisfaction between the ambulatory phlebectomy and sclerotherapy groups. Twelve per cent of the sclerotherapy patients developed true recurrences or new varicosities compared to 11% in the ambulatory phlebectomy group. The most common complication was superficial thrombophlebitis (20% ambulatory phlebectomy, 16% sclerotherapy) which was mild in all cases. All but three patients in the ambulatory phlebectomy group returned to work within 7 days and 75% returned to full duty within 72 hours. Completion of therapy was accomplished in a much shorter period for the ambulatory phlebectomy group. Overall patient satisfaction was achieved for both ambulatory phlebectomy and sclerotherapy patients. Completion of therapy was achieved in a shorter period with fewer clinic visits in the ambulatory phlebectomy group and this has become our procedure of choice for active duty military patients.