Treatment of mild to moderate obesity with laparoscopic adjustable gastric banding or an intensive medical program: a randomized trial. Physical and psychosocial outcome in morbidly obese patients with and without bariatric surgery: a 4 1/2-year follow-up. Randomized controlled trial testing the effects of weight loss on nonalcoholic steatohepatitis. Effects of bariatric surgery on nonalcoholic fatty liver disease: preliminary findings after 2 years. Roux-en-Y gastric bypass improves the nonalcoholic steatohepatitis (NASH) of morbid obesity. Prospective study of the long-term effects of bariatric surgery on liver injury in patients without advanced disease. Non-alcoholic steatohepatitis: effect of Roux-en-Y gastric bypass surgery. Resolution of nonalcoholic steatohepatits after gastric bypass surgery. Gynaecologic surgery from uncertainty to science: evolution of randomized control trials. Laparoscopic adjustable gastric banding versus open vertical banded gastroplasty: a prospective randomized trial. Open versus laparoscopic vertical banded gastroplasty: a randomized controlled double blind trial. Nonalcoholic fatty liver disease treated by gastroplasty. Randomized controlled trials in pediatric surgery: could we do better? Nonalcoholic fatty liver disease: Improvement in liver histological analysis with weight loss. Randomized clinical trial of laparoscopic Roux-en-Y gastric bypass versus laparoscopic vertical banded gastroplasty for obesity. Physicians' reasons for not entering eligible patients in a randomized clinical trial of surgery for breast cancer. An unblinded randomised controlled trial of preoperative oral supplements in colorectal cancer patients. Surgery for Obesity- An Update of a Randomized Trial. Gastric Bypass and Vertical Banded Gastroplasty- a Prospective Randomized Comparison and 5-Year Follow-up. Laparoscopic versus open gastric bypass: a randomized study of outcomes, quality of life, and costs. Neo-adjuvant chemotherapy for operable gastric cancer: long term results of the Dutch randomised FAMTX trial.
Obesity is a major, growing health problem. Observational studies suggest that bariatric surgery is more effective than nonsurgical therapy, but no randomized, controlled trials have confirmed this.
                To ascertain whether surgical therapy for obesity achieves better weight loss, health, and quality of life than nonsurgical therapy.
                Randomized, controlled trial.
                University departments of medicine and surgery and an affiliated private hospital.
                80 adults with mild to moderate obesity (body mass index, 30 kg/m2 to 35 kg/m2) from the general community. Interventions: Patients were assigned to a program of very-low-calorie diets, pharmacotherapy, and lifestyle change for 24 months (nonsurgical group) or to placement of a laparoscopic adjustable gastric band (LAP-BAND System, INAMED Health, Santa Barbara, California) (surgical group).
                Outcome measures were weight change, presence of the metabolic syndrome, and change in quality of life at 2 years.
                At 2 years, the surgical group had greater weight loss, with a mean of 21.6% (95% CI, 19.3% to 23.9%) of initial weight lost and 87.2% (CI, 77.7% to 96.6%) of excess weight lost, while the nonsurgical group had a loss of 5.5% (CI, 3.2% to 7.9%) of initial weight and 21.8% (CI, 11.9% to 31.6%) of excess weight (P < 0.001). The metabolic syndrome was initially present in 15 (38%) patients in each group and was present in 8 (24%) nonsurgical patients and 1 (3%) surgical patient at the completion of the study (P < 0.002). Quality of life improved statistically significantly more in the surgical group (8 of 8 subscores of Short Form-36) than in the nonsurgical group (3 of 8 subscores).
                The study included mildly and moderately obese participants, was not powered for comparison of adverse events, and examined outcomes only for 24 months.
                Surgical treatment using laparoscopic adjustable gastric banding was statistically significantly more effective than nonsurgical therapy in reducing weight, resolving the metabolic syndrome, and improving quality of life during a 24-month treatment program. Morbidly obese patients show high somatic and psychiatric co-morbidity. Bariatric surgery is accepted as the obesity treatment with the greatest long-term success. There is growing evidence that follow-up studies should address somatic as well as psychosocial conditions of patients undergoing bariatric surgery and non-operatively treated patients. This study investigates the physical and psychosocial outcomes of patients with and without bariatric surgery.
                A sample of 131 morbidly obese patients applying for bariatric surgery underwent somatic and psychological assessment (T0). A first follow-up study (T1) was conducted 2 years after T0 in 119 patients. The present second follow-up (T2) was carried out 4 1/2 years after T0 and 3.2 years after potential bariatric surgery. Psychological/psychosocial measures were collected in the 93 patients, 63 of whom were treated surgically, via the Psychosocial Stress and Symptom Questionnaire (PSSQ) and a telephone interview covering BMI, employability, medication, doctor consultations, eating behavior, and physical/psychological well-being.
                Patients with and without bariatric surgery showed a BMI reduction, which was significantly greater in those who underwent surgery (P<.001). The average percentage of excess weight loss (%EWL) between T0 and T2 was 11.5% in patients with no bariatric surgery, 36.0% in patients with laparoscopic gastric banding, and 52.8% in patients with laparoscopic gastric bypass (%EWL between T0 and T2 in patients of all groups significant, P<.001). Patients with and without surgical treatment showed significant improvement with regard to depressive symptoms and binge-eating behavior. Three-quarters of the surgically-treated and two-thirds of the non-treated patients rated their physical, psychological, and psychosocial well-being as "good" at T2.
                After 3 to 4 years, all of the patients have adapted well to their weight and body appearance, regardless of whether they have undergone surgery. Weight loss is, however, greater for operated patients, which strongly decreases the risk of developing obesity-related co-morbidities. Nonalcoholic steatohepatitis (NASH) is a chronic progressive liver disease that is strongly associated with obesity. Currently, there is no approved therapy for NASH. Weight reduction is typically recommended, but efficacy data are lacking. We performed a randomized controlled trial to examine the effects of lifestyle intervention using a combination of diet, exercise, and behavior modification, with a goal of 7% to 10% weight reduction, on clinical parameters of NASH. The primary outcome measure was the change in NASH histological activity score (NAS) after 48 weeks of intervention. Thirty-one overweight or obese individuals (body mass index [BMI], 25-40 kg/m(2)) with biopsy-proven NASH were randomized in a 2:1 ratio to receive intensive lifestyle intervention (LS) or structured education (control). After 48 weeks of intervention, participants assigned to LS lost an average of 9.3% of their weight versus 0.2% in the control group (P = 0.003). A higher proportion of participants in the LS group had a reduction of NAS of at least 3 points or had posttreatment NAS of 2 or less as compared with the control group (72% versus 30%, P = 0.03). NAS improved significantly in the LS group (from 4.4 to 2.0) in comparison with the control group (from 4.9 to 3.5) (P = 0.05). Percent weight reduction correlated significantly with improvement in NAS (r = 0.497, P = 0.007). Participants who achieved the study weight loss goal (>or=7%), compared with those who lost less than 7%, had significant improvements in steatosis (-1.36 versus -0.41, P < 0.001), lobular inflammation (-0.82 versus -0.24, P = 0.03), ballooning injury (-1.27 versus -0.53, P = 0.03) and NAS (-3.45 versus -1.18, P < 0.001).
                Weight reduction achieved through lifestyle intervention leads to improvements in liver histology in NASH. Although nonalcoholic fatty liver disease (NAFLD) is very common among morbidly obese patients, the effect of weight loss after bariatric surgery on inflammation and fibrosis related to NAFLD is still a matter of debate. The aim of this study was to evaluate the impact of Roux-en-Y gastric bypass (RYGB) surgery on NAFLD with a follow up of 2 years.
                Eighteen consecutive NAFLD patients with body mass index >40 kg/m(2) undergoing gastroplasty with RYGB were enrolled, and wedge liver biopsy was obtained at the operation. After 2 years, these patients underwent percutaneous liver biopsy.
                At baseline, 67% of patients had nonalcoholic steatohepatitis (NASH) and 33% had steatosis, according to the NASH Clinical Research Network Scoring System (NAS) for biopsy. Cirrhosis was present in 5.5% of the patients with NASH. After a mean excess weight loss of 60%, steatosis disappeared in 84% and fibrosis disappeared in 75% of the patients. Hepatocellular ballooning disappeared in 50%. A slight lobular inflammatory infiltrate remained in 81%, apparently unrelated to fatty degeneration. As liver biochemical variables had been found within normal limits in 92.3% of patients at initial biopsy, no difference was found 2 years later. Lipid profile and blood sugar plasma concentration were closer to normal in all patients after 2 years (P < 0.05).
                Aspects of NAFLD including steatohepatitis improved significantly with massive weight loss at 2 years after RYGB surgery. No patient in this series had progression of hepatic fibrosis. Hepatic steatosis and nonalcoholic steatohepatitis (NASH) have been increasingly implicated in the genesis of hepatic fibrosis and cirrhosis. However, no consensus exists about whether weight reduction may reverse this process.
                To assess the effect of Roux-en-Y gastric bypass (RYGBP) on the histological evolution of NASH diagnosed in 64 patients by routine liver biopsy ("first" biopsy) performed during surgery, we performed a "second" biopsy after 23.5 +/- 8.4 months in 16 patients (14 female, 2 male).
                From the first to the second biopsy, BMI decreased from 53.4 +/- 8.8 kg/m2 to 31.1 +/- 4.7 kg/m2, arterial hypertension decreased from 75% to 43.8%, and type 2 diabetes decreased from 43.8% to zero. On the first biopsy, nonalcoholic fatty liver disease (NAFLD) type 3 was observed in 12 patients (75%) and type 4 in 4 (25%). The second biopsy revealed complete regression of NAFLD in 15 patients (93.7%) and only 1 (6.3%) had NAFLD type 1 (mild steatosis without inflammation). Complete regression of necroinflammatory activity was observed in all patients. Among the 4 patients presenting fibrosis in the first biopsy, complete remission was observed in 1 and improvement in 1. Two continued to show the same degree of fibrosis without evidence of disease activity. No worsening of steatosis, necroinflammatory activity or fibrosis was observed in any of the patients, and none progressed to cirrhosis.
                RYGBP improves steatosis, necroinflammatory activity and hepatic fibrosis in patients with morbid obesity and NASH. Severe obesity is implicated in development of nonalcoholic fatty liver disease (NAFLD). Bariatric surgery induces weight loss and increases survival time of obese patients, but little is known about its effects on liver damage. We performed a 5-year prospective study to evaluate fibrosis and nonalcoholic steatosis (NASH) in severely obese patients after bariatric surgery.
                Bariatric surgery was performed on 381 patients. Clinical and biological data, along with liver biopsies, were collected before and at 1 and 5 years after surgery.
                Five years after surgery, levels of fibrosis increased significantly, but 95.7% of patients maintained a fibrosis score <or= F1. The percentage of patients with steatosis decreased from 37.4% before surgery to 16%, the NAFLD score from 1.97 to 1, ballooning from 0.2 to 0.1. Inflammation remained unchanged. The percentage of patients with probable or definite NASH decreased significantly over 5 years, from 27.4% to 14.2%. The kinetics of insulin resistance (IR) paralleled that of steatosis and ballooning; the greatest improvements occurred within the first year and were sustained 5 years later. Steatosis and ballooning occurred more frequently in patients with a refractory IR profile. In multivariate analysis, the refractory IR profile independently predicted the persistence of steatosis and ballooning 5 years later.
                Five years after bariatric surgery for severe obesity, almost all patients had low levels of NAFLD, whereas fibrosis slightly increased. Steatosis and ballooning were closely linked to IR; long-term effects could be predicted by early improvement in IR. Non-alcoholic steatohepatitis (NASH) is an increasingly prevalent problem. Treatment options are still under investigation. The primary aim of the study was to determine whether weight loss, achieved through Roux-en-Y gastric bypass (RYGBP), improved histopathology in obese patients with biopsy proven NASH.
                One hundred and forty-nine patients were identified from a surgical database as having RYGBP for obesity and concomitant intra-operative liver biopsies from October 2001 to September 2003. Thirty-five patients were found to have evidence of NASH at the time of surgery. Nineteen patients were contacted and underwent repeat percutaneous liver biopsies. Biopsies were evaluated and compared in blinded fashion by an experienced hepatopathologist. Fasting lipid panel, insulin and glucose, hemoglobin A1c (HgbA1c), and liver enzymes were obtained.
                Significant differences were noted in the following variables pre- and post-bypass surgery: body mass index 46.8-28.8 kg/m2 (p < 0.001); body weight in kilograms 132.1-79.7 (p < 0.001); glucose 102.9-94.1 mg/dL (p = 0.015); Hgb A1c 5.79-5.15% (p = 0.026); high density lipoprotein 45.7-64.4 mg/dL (p < 0.001); low density lipoprotein 112-88.6 mg/dL (p = 0.003); triglycerides 132.1-97 mg/dL (p = 0.013). Significant improvements in steatosis, lobular inflammation, portal, and lobular fibrosis were noted. Histopathologic criteria for NASH were no longer found in 17/19 patients (89%).
                Weight loss after gastric bypass surgery in obese patients with NASH results in significant improvement in glucose, HgbA1c. and lipid profiles. Furthermore, RYGBP results in significant improvement in the histological features of NASH with resolution of disease in a majority of these patients. Nonalcoholic fatty liver disease (NAFLD) has been increasingly recognized as a common chronic liver condition. Previous studies have been variable regarding the histological outcomes after rapid weight loss. The aim of this study was to characterize the histopathologic changes in NASH following laparoscopic Roux-en-Y Gastric Bypass surgery (LRYGBP).
                We retrospectively analyzed paired needle liver biopsies taken during and following LRYGBP in 39 patients according to the recent NIH-based NAFLD criteria.
                The cohort included 33 females and 6 males (range 24-57 years). 23 patients (58.9%) had steatohepatitis, 12 with fatty liver (30.7%), and 4 were normal (10.2%). Follow-up needle liver biopsies were performed at a mean interval of 18 months (range 6-41 months). No significant differences in length or number of portal tracts between the paired biopsies were noted. The mean decrease in weight and BMI was 50.2 kg and 18.2 kg/m2, respectively. The initial prevalence of hepatic pathology: steatosis (89.7%), hepatocellular ballooning (58.9%), and centrilobular/perisinusoidal fibrosis (50%) improved significantly after LRYGBP: steatosis (2.9%), ballooning (0%), and centrilobular fibrosis (25%). Mitigation in the lobular inflammation score (2.23+/-0.63 vs 1.95+/-0.56, P=0.01) and stage of fibrosis (1.14+/-1.05 to 0.72+/-0.97, P=0.002) were also noted. However, no improvements were detected in portal tract inflammation and fibrosis.
                Over a mean period of 18 months, histological improvements and resolution of NASH occurs after LRYGBP. Long-term studies are warranted to assess for potential changes in the portal regions or relapse of NASH that could result with weight regain or malnutrition. It is now accepted that both medical and surgical practice should be based on reliable and sound clinical evidence. However, randomized control trials comparing surgical interventions have been associated with many problems. The aim of this review is to assess if there has been progress made in establishing the evidence base for surgical interventions in gynaecology.
                Relevant reviews were identified from Cochrane Database of Systematic Reviews (Issue , 2006) and data from individual randomized control trials extracted. Chi-squared test was used to compare quality pre- and post-Consolidated Standards of Reporting Trials (CONSORT) statement. Meta-regression analyses were performed to test the hypothesis that effect size decreased over time. Further multiple linear regression analyses were used to test the hypothesis that precision increased over time and finally a logistic regression model was used to estimate whether treatment effects differed between trials with and without allocation concealment.
                Twenty-three relevant reviews were identified, including 94 trials. The proportion of studies reporting allocation concealment significantly increased after the introduction of the CONSORT statement (P = 0.002). There was a trend towards improvement in precision over time. Similarly, there was a reduction in size of treatment effect over time (log of the ratio of odds ratios per year 0.96; 95% confidence interval 0.93-0.99, P = 0.04).
                Gynaecologic surgical practice appears to be benefiting from improvement in its research base in a subject where practitioners do not participate readily in randomized evaluation. Laparoscopic adjustable gastric banding (LAGB) and open vertical banded gastroplasty (VBG) are treatment modalities for morbid obesity. However, few prospective randomized clinical trials (RCT) have been performed to compare both operations.
                100 patients (50 per group) were included in the study. Postoperative outcomes included hospital length of stay (LOS), complications, percent excess weight loss (%EWL), BMI and reduction in total comorbidities. Follow-up in all patients was 2 years.
                LOS was significantly shorter in the LAGB group. 3 LAGB were converted to open (1 to gastric bypass). Directly after VBG, 3 patients needed relaparotomies due to leakage, of which one (2%) died. After 2 years, 100% follow-up was achieved. BMI and %EWL were significantly decreased in both groups but significantly more in the VBG group compared to the LAGB group (31.0 kg/m2 and 70.1% vs 34.6 and 54.9% respectively). Co-morbidities significantly decreased in both groups in time. 2 years after LAGB, 20 patients needed reoperation for pouch dilation/slippage (n=12), band leakage (n=2), band erosion (n=2) and access-port problems (n=4). In the VBG group, 18 patients needed revisional surgery due to staple-line disruption (n=15), narrow outlet (n=2) or insufficient weight loss (n=1). Furthermore, 8 VBG patients developed an incisional hernia.
                This RCT demonstrates that, despite the initial better weight loss in the VBG group, based on complication rates and clinical outcome, LAGB is preferred. It had a shorter LOS and less postoperative morbidity. Vertical banded gastroplasty (VBG) is a frequently used surgical procedure for the treatment of morbid obesity. It can be done open (OVBG) or laparoscopic (LVBG). The aim of this double-blind randomized clinical trial was to compare the postoperative outcome and 1-year follow-up of 2 cohorts of patients who underwent either OVBG or LVBG.
                30 patients with morbid obesity were randomized into 2 groups (14 OVBG and 16 LVBG). Pain intensity, analgesic requirements, respiratory function, and physical activity were blindly analyzed during the first 3 postoperative days. Complications, weight loss, and cosmetic results after 1 year follow-up were evaluated.
                Both groups were highly comparable before surgery. Surgical time was longer in the laparoscopic procedure. Patients in this group required less analgesics during the first postoperative day. There was an earlier recovery in the expiratory and inspiratory forces, as well as faster recovery of physical activities in patients who underwent LVBG. Postoperative complications were more frequent in the open group. Excess body weight loss after 1 year was similar in both groups. Cosmetic results were significantly better in the laparoscopic group.
                LVBG had advantages over the open procedure in terms of analgesic requirements, respiratory function, postoperative recovery, and cosmetic results. Nonalcoholic steatohepatitis (NASH), which is the most severe histologic form of nonalcoholic fatty liver disease (NAFLD), is emerging as the most common clinically important form of liver disease in obese patients. The prevalence of NASH may increase with the rise in the rate of obesity and metabolic syndrome in affluent communities. The aim of this work is to describe clinical and histopathologic findings and correlate liver tissue damage to the length of duration of the obesity in the group of patients who underwent surgery as obesity treatment. Eighty-seven severely or morbidly obese patients underwent gastroplasty. Each patient was evaluated with complete clinical and laboratory medical assessment together with wedge liver biopsy taken from 59 unselected patients during the surgery. Patients were followed up for 41 months. Repeat liver biopsy was taken from 10 patients. Pathologic analysis recorded the presence and degree of steatosis, portal and lobular inflammation and fibrosis. Age, body mass index (BMI), and laboratory assessment correlated with pathologic data. Male patients showed more pronounced metabolic syndrome and fatty liver damage. Patients who become obese in childhood or as teenagers showed no differences in metabolic syndrome and NAFLD in mature age. There was statistically significant association between BMA, elevated transaminases, NAFLD, and fibrosis. Significant weight reduction was observed within first year after surgery, was slower in the second year, and stabilized within third year. Remarkable improvement followed in biological markers of metabolic syndrome. Ninety-six percent of initial liver biopsies had steatosis; 16% developed steatohepatitis and mild perivenular fibrosis. Significant improvement of the degenerative and inflammatory hepatic lesions in repeated biopsies and liver function readings was noted within 8 months after surgery. Obesity is a major and independent risk factor for the metabolic syndrome, NAFLD, NASH, and fibrosis. Surgical treatment improves metabolic abnormalities and hepatic lesions in long-term observations. Randomized controlled trials (RCTs) are accepted as the gold standard for assessing the effectiveness of clinical interventions but are rarely reported in pediatric surgery. Have RCTs submitted to the British Association of Paediatric Surgeons (BAPS) Annual Congress during the last 5 years been adequately designed and large enough to produce a valid result?
                Abstracts accepted by the Annual BAPS Congress meetings between 1996 and 2000 were examined in collaboration with a senior health services researcher. The quality of the design, methodology, statistical analysis and conclusions, and the adequacy of the sample size were assessed for all identifiable clinical RCTs.
                From 760 accepted abstracts, there were only 9 RCTs (1%) of clinical interventions. In only 4 trials was the relevant primary end-point specified at the outset of the study, and none documented the method of randomization. Only one abstract mentioned blinding with respect to the intervention or outcome measure. Sample sizes were inadequate to detect even large clinical differences. To date, only one of these RCTs has been published in an English-language, peer-reviewed journal.
                Clear guidelines exist for the conduct of RCTs, yet compliance with these standards was rarely documented in abstracts of pediatric surgical RCTs presented at BAPS. Sample sizes were inadequate. RCTs in pediatric surgery are difficult to perform, but the specialty would benefit from well-designed, carefully conducted, multicentre, clinical RCTs to advance evidence-based practice.
                Copyright 2003, Elsevier Science (USA). All rights reserved. The effect of significant weight loss on nonalcoholic fatty liver disease remains unclear. In this case series of 36 selected obese patients, we examined the effect of weight loss on nonalcoholic fatty liver disease, including nonalcoholic steatohepatitis (NASH) and hepatic fibrosis. These 36 patients (11 males, 25 females) had paired liver biopsies, the first at the time of laparoscopic adjustable gastric band placement and the second after weight loss. Second biopsies were obtained from two groups: those requiring a subsequent laparoscopic procedure (n = 19) and those with index biopsy score of 2 or greater for zone 3-centric hepatic fibrosis (n = 17). All biopsies were scored, blinded to the patient's identity and clinical condition, for individual histological features and for NASH stage and grade. Initial biopsies demonstrated NASH in 23 patients and steatosis in 12 patients. Repeat biopsies were taken at 25.6 +/- 10 months (range, 9-51 months) after band placement. Mean weight loss was 34.0 +/- 17 kg, and percentage of excess weight loss was 52 +/- 17%. There were major improvements in lobular steatosis, necroinflammatory changes, and fibrosis at the second biopsy (P <.001 for all). Portal abnormalities remained unchanged. Only four of the repeat biopsies fulfilled the criteria for NASH. There were 18 patients with an initial fibrosis score of 2 or more compared with 3 patients at follow-up (P <.001). Those with the metabolic syndrome (n = 23) had more extensive changes before surgery and greater improvement with weight loss. In conclusion, weight loss after surgery provides major improvement or resolution of obesity and metabolic syndrome-associated abnormal liver histological features in severely obese subjects. Laparoscopic techniques have been developed for performing Roux-en-Y gastric bypass (LRYGBP) and vertical banded gastroplasty (LVBG) in patients with morbid obesity. It is not certain, however, which is the better technique in non-superobese patients (body mass index less than 50 kg/m(2)).
                Eighty-three patients (LRYGBP 37, LVBG 46) were assessed in a randomized clinical trial. Perioperative complications were recorded together with preoperative and postoperative respiratory function and mobilization rate. Patients were monitored for 2 years after operation with regard to weight change and the need for remedial surgery.
                There were no conversions to open surgery. The mean operating time was longer for LRYGBP than LVBG (138 versus 105 min). Five early reoperations were performed after LRYGBP (three for haemorrhage, one for ileus and one suspected leak) and one after LVBG (suspected leak). There were no differences in postoperative respiratory function or mobilization. Weight reduction was greater after LRYGBP (excess weight loss 78.3 versus 62.9 per cent 1 year after surgery, P = 0.009; 84.4 versus 59.8 per cent at 2 years, P < 0.001). Remedial surgical intervention was required in eight patients after LVBG (conversion to Roux-en-Ygastric bypass) and none after LRYGBP.
                LRYGBP and LVBG were comparable in terms of operative safety and postoperative recovery, but weight reduction was better after LRYGBP.
                Copyright (c) 2005 British Journal of Surgery Society Ltd. Published by John Wiley & Sons, Ltd. We studied the reasons surgical principal investigators chose not to enter patients in a large, multicenter trial sponsored by a cooperative group. In 1976 the National Surgical Adjuvant Project for Breast and Bowel Cancers (NSABP) initiated a clinical trial to compare segmental mastectomy and postoperative radiation, or segmental mastectomy alone, with total mastectomy. Because the low rates of accrual were threatening to close the trial prematurely, we mailed a questionnaire to the 94 NSABP principal investigators, asking why they were not entering eligible patients in the trial. A response rate of 97 per cent was achieved. Physicians who did not enter all eligible patients offered the following explanations: (1) concern that the doctor-patient relationship would be affected by a randomized clinical trial (73 per cent), (2) difficulty with informed consent (38 per cent), (3) dislike of open discussions involving uncertainty (22 per cent), (4) perceived conflict between the roles of scientist and clinician (18 per cent), (5) practical difficulties in following procedures (9 per cent), and (6) feelings of personal responsibility if the treatments were found to be unequal (8 per cent). Further investigation into the behavioral aspects of the investigator-patient relationship is particularly pressing, since fear of change in this relationship was the most common reason given for not entering eligible patients in the trial. Perioperative oral supplementation has been shown to reduce post-operative complications. However, the use of preoperative standard oral supplements in a cohort of colorectal cancer patients has not been evaluated. The present study examined whether preoperative supplements are beneficial in this group.
                In a randomised controlled trial, patients were assigned to receive 400 mL of oral supplement and dietary advice or dietary advice alone. Primary outcome was the number of post-operative complications. One hundred and twenty-five patients were recruited (59 randomised to the intervention group and 66 to the control group) and nine were excluded.
                In the intervention group, 24 (44%) patients had a complication compared to 26 (42%) in the control group (P = 0.780). In the intervention and control groups, there were eight (15%) and 16 (25%) surgical site infections, respectively (P = 0.140) and seven (13%) and 11 (17%) chest infections, respectively (P = 0.470). Subgroup analysis for hypothesis generation included 83 (71%) weight-losing patients, where there was a significant reduction in surgical site infections using the Buzby definition (P = 0.034), although this was not the case for the Centre for Disease Control definition (P = 0.052).
                There was no evidence that preoperative supplements were beneficial in reducing the number of complications, although there may be some benefit for surgical site infections in selected weight-losing preoperative patients.
                © 2011 The Authors. Journal of Human Nutrition and Dietetics © 2011 The British Dietetic Association Ltd. BACKGROUND: A prospective, randomized trial comparing vertical banded gastroplasty (VBG) and gastric bypass (GB) was performed on 106 patients between 1987 and 1990. METHODS AND RESULTS: Failures of these two operations (manifested by failure to lose weight, late weight gain or intolerance of adequate oral intake) were treated by means of a third operation, isolated gastric bypass (IGB), in which the small gastric pouch was isolated from the gastric fundus. The latter operation was significantly better than VBG or GB and achieved a 63% success rate, i.e. body mass index (BMI) < 35 kg m(2) and less than 50% excess weight. During the year following this trial an additional 54 patients underwent IGB. When this operation was performed for morbid obesity and was the Initial procedure, 96% of the patients achieved a successful result. If IGB was performed as a revision procedure or for super obesity (BMI > 50 kg m(2)), the success rate was 63% with 100% follow-up at 40 months. Major morbidity occurred in six of the 160 patients who underwent 195 operations (the trial period and subsequent year). There were no deaths and follow-up was 98%. CONCLUSIONS: The ideal gastric operation based on this study emphasizes the following requirements: a small pouch (< 15 ml) totally separated from the stomach, a pouch not dependent on staples, placed in the dependent position to prevent stasis, constructed without foreign material and with an anastomosis which permits ingestion of solid food. BACKGROUND: a prospective randomized study was undertaken to compare the outcome of vertical banded gastroplasty (VBG) and gastric bypass (GBP) in patients with clinically severe obesity. METHODS: eligibility criteria included Class IV obesity, < 50 years old and a history of at least one attempt of non-operative weight loss. Patients were managed conservatively for 3 months prior to surgery. Patients were followed post-operatively and monitored for early and late complications and their weight loss outcome for up to 5 years. RESULTS: 44 patients were recruited. Two patients withdrew within 4 weeks and were excluded. Twenty subjects had a GBP and 22 a VBG. There were no significant differences with respect to age, gender, maximum or pre-operative weight between the groups (p > 0.05). Patients who underwent GBP demonstrated significantly greater post-operative weight loss (p < 0.05) which was apparent from 6 months onwards. There were no deaths, pulmonary emboli, post-operative leaks or wound dehiscence. There were no instances of staple-line disruption. Symptomatic ulcer disease, confirmed endoscopically, developed in 25% of GBP patients. Nine patients developed gallstones post-operatively of whom five were in the VBG and four in the GBP group. CONCLUSIONS: weight loss following GBP was maintained, while VBG patients slowly regained. To compare outcomes, quality of life (QOL), and costs of laparoscopic and open gastric bypass (GBP).
                Laparoscopic GBP has been reported to be a safe and effective approach for the treatment of morbid obesity. The authors performed a prospective randomized trial to compare outcomes, QOL, and costs of laparoscopic GBP with those of open GBP.
                From May 1999 to March 2001, 155 patients with a body mass index (BMI) of 40 to 60 kg/m2 were randomly assigned to undergo laparoscopic (n = 79) or open (n = 76) GBP. The two groups were similar in age, sex ratio, mean BMI, and comorbidities. Main outcome measures included operative time, estimated blood loss, length of hospital stay, operative complications, percentage of excess body weight loss, and time to return to activities of daily living and work. Changes in QOL were assessed using the SF-36 Health Survey and the bariatric analysis of reporting outcome system (BAROS). Operative and hospital costs of the two operations were also compared.
                There were no deaths in either group. Mean operative time was longer for laparoscopic GBP than for open GBP, but operative blood loss was less. Two (2.5%) of the 79 patients in the laparoscopic group required conversion to laparotomy. Median length of hospital stay was shorter for laparoscopic GBP patients (3 vs 4 days). The rate of postoperative anastomotic leak was similar between groups. Wound-related complications such as infection (10.5 vs 1.3%) and incisional hernia (7.9 vs 0%) were more common after open GBP; late anastomotic stricture was less frequent after open GBP (2.6 vs 11.4%). Time to return to activities of daily living and work were shorter after laparoscopic GBP than after open GBP. Weight loss at 1 year was similar between groups. Preoperative SF-36 scores were similar between groups; however, at 1 month after surgery, laparoscopic patients had better physical conditioning, social functioning, general health, and less body pain than open GBP patients. At 6 months, the BAROS outcome was classified as good or better in 97% of laparoscopic GBP patients compared with 82% of open GBP patients. Operative costs were higher for laparoscopic GBP patients, but hospital costs were lower.
                Laparoscopic GBP is a safe and cost-effective alternative to open GBP. Despite a longer operative time, patients undergoing laparoscopic GBP benefited from less blood loss, a shorter hospital stay, and faster convalescence. Laparoscopic GBP patients had comparable weight loss at 1 year but a more rapid improvement in QOL than open GBP patients. The higher initial operative costs for laparoscopic GBP were adequately offset by the lower hospital costs. Gastric cancer in Western countries is often diagnosed in an advanced stage and prognosis is poor. We performed a randomised trial with pre-operative FAMTX vs. surgery alone in order to evaluate the effect of pre-operative chemotherapy on resectability and survival.
                Patients with proven adenocarcinoma of the stomach were randomised to receive four courses of chemotherapy using 5-Fluorouracil, doxorubicin and methotrexate (FAMTX) prior to surgery or to undergo surgery alone.
                Fifty-nine patients were randomised; 29 patients were allocated to the FAMTX regimen prior to surgery and 30 patients had surgery alone. Resectability rates were equal for both groups. Complete or partial response was registered in 32% of the FAMTX group. With a median follow-up of 83 months the median survival since randomisation is 18 months in the FAMTX group vs. 30 months in the surgery alone group (p=0.17).
                This trial could not show a beneficial effect of pre-operative FAMTX. Until large randomised studies prove otherwise, adequate surgery without delay is the best treatment for operable gastric cancer.
The lack of randomised clinical trials and quasi-randomised clinical studies precludes us to assess the benefits and harms of bariatric surgery as a therapeutic approach for patients with NASH. Limitations of all other studies with inferior design did not allow us to draw any unbiased conclusion on bariatric surgery for treatment of NASH.