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Biomedical subjects

Paul E O'Brien

Publications and source records attributed to Paul E O'Brien.

At least 37 records · Page 2Linked to original sources

A prospective, randomized, controlled clinical trial of placement of the artificial bowel sphincter (Acticon Neosphincter) for the control of fecal incontinence.

BACKGROUND: Severe fecal incontinence remains a disabling condition for the patient and a major therapeutic challenge for the physician. A series of observational studies have indicated that placement of an artificial bowel sphincter is associated with marked improvement of continence and quality of life. We have performed a prospective, randomized, controlled trial to evaluate the effect of placement of an artificial bowel sphincter (Acticon Neosphincter) on continence and quality of life in a group of severely incontinent adults. METHODS: Fourteen adults (male:female, 1:13; age range, 44-75 years) were randomized to placement of the artificial bowel sphincter or to a program of supportive care and were followed for six months from operation or entry into the study. The principal outcome measure was the level of continence, measured with the Cleveland Continence Score, which provides a scale from 0 to 20, representing perfect control through to total incontinence. Secondary outcome measures were perioperative and late complications in the artificial bowel sphincter group, and the changes in quality of life in both groups. RESULTS: In the control group, the Cleveland Continence Score was not significantly altered, with an initial value of 17.1 +/- 2.3 and a final value of 14.3 +/- 4.6 at six months. The artificial bowel sphincter group showed a highly significant improvement, changing from 19.0 +/- 1.2 before placement to 4.8 +/- 4.0 at six months after placement. One patient in the artificial bowel sphincter group had failure of healing of the perineal wound and explantation of the device (14 percent explantation rate). There were two other significant perioperative events of recurring fecal impaction initially after placement in one patient and additional suturing of the perineal wound in another. There were major improvements in the quality of life for all measures in the artificial bowel sphincter group. There was significant improvement in all eight subscales of the Medical Outcome Study Short Form-36 measures. The American Medical Systems Quality of Life score was raised from 39 +/- 6 to 83 +/- 14 and the Beck Depression Inventory showed reduction from a level of mild depression (10.8 +/- 9.3) to a normal value (6.8 +/- 8.7). No significant changes in any of the quality of life measures occurred for the control group. CONCLUSIONS: Through a prospective, randomized trial format, we have shown that placement of an artificial bowel sphincter is safe and effective when compared with supportive care alone. Perioperative and late problems are likely to continue to occur and between 15 percent and 30 percent of patients may require permanent explantation. For the remainder, the device is easy and discrete to use, highly effective in achieving continence, and able to generate a major improvement in the quality of life.

Adult↗

Sustained weight loss in obese subjects has benefits that are independent of attained weight.

OBJECTIVE: To explore the hypothesis that sustained weight loss in severely obese patients may have benefits that are independent of their attained BMI. RESEARCH METHODS AND PROCEDURES: We conducted a comparison of two weight-stable groups with BMI in the 30 to 35 kg/m(2) range. Subjects (n = 79) were selected obese patients 3 years after laparoscopic adjustable gastric band surgery, and controls (n = 79) were obese patients seeking weight loss therapy. Subjects were selected in a de-identified manner from our database to best match the control group. A range of clinical, biochemical, and questionnaire measures were obtained to assess obesity-related health status RESULTS: Subjects maintained a mean weight loss of 32.8 +/- 18 kg after surgery. The weight loss subjects had significantly lower fasting plasma glucose, insulin, and triglyceride concentrations, along with higher high-density lipoprotein-cholesterol levels and better indirect measures of insulin sensitivity when compared with controls (p < 0.05 for all). In addition, aminotransferase levels, neutrophil counts, and globulin levels were also significantly lower in weight loss subjects. All differences in laboratory variables remained significant after controlling for BMI. The subjects also reported better health-related quality of life, fewer symptoms of depression, and greater satisfaction with their appearance than controls. DISCUSSION: These findings suggest that the post-weight loss state conveys benefits that are greater than predicted by the attained BMI. These findings may have important implications regarding the expectations of weight loss therapy, and mechanisms for this effect should be carefully sought.

Blood Glucose↗

Patient motivation for bariatric surgery: characteristics and impact on outcomes.

BACKGROUND: Motivation for seeking obesity surgery has not been studied. The authors explored the patient's motivation for selecting surgery and examined for a relationship between primary motivating factors and weight outcomes. METHODS: 208 (177F: 31M) unselected participants followed at least 1 year after Lap-Band placement completed a short questionnaire. 6 statements were scored 1-6 from the most important through to the least important. Statements included appearance, embarrassment, medical conditions, health concerns, physical fitness and physical limitation. Any additional factors were also sought. RESULTS: Mean age, weight and BMI before surgery were 41+/-10 years, 129+/-16 kg and 46+/-8 kg/m(2) respectively. Responses to appearance and embarrassment correlated strongly and were grouped together. Medical conditions and health concerns account for 52%, appearance and embarrassment for 32%, and poor physical fitness and physical limitation for 16% of first choices. Those who scored 1 for appearance or embarrassment (n=67) had a lower presenting BMI (44 kg/m(2), P=0.03) and all but 1 were female (P<0.001). This group reported more depressive symptoms, poorer mental quality of life and poorer body image preoperatively. Men were more likely than women to be motivated by medical problems (P=0.007). Subjects motivated by a medical condition were more likely to have hypertension or diabetes and less likely to smoke. This group tended to be older. Weight history did not influence motivation. The first choice of motivating factor was not associated with weight outcomes at 1-3 years following surgery. CONCLUSION: Health issues dominate the motivation for seeking surgery. Weight outcomes do not appear to be affected by the patient's primary motivating factor.

Adult↗

Depression in association with severe obesity: changes with weight loss.

BACKGROUND: The relationship between depression and severe obesity is unclear. We examined depression before and after surgically induced weight loss. METHODS: Beck Depression Inventory (BDI) questionnaires were completed before and at yearly intervals after gastric-restrictive weight-loss surgery. We used the BDI scores of 487 consecutive patients to identify predictors of depression. Scores from all completed questionnaires were used to follow changes with time. Paired preoperative and 1-year postoperative scores (n = 262) were used to identify predictors of change in BDI score. RESULTS: For the 487 subjects, the mean +/- SD preoperative BDI score was 17.7 +/- 9.5. Higher scores, indicating increased symptoms of depression, were found in younger subjects, women, and those with poorer body image. These factors had independent effects. We found no association between BDI and waist circumference or insulin concentrations. High BDI scores correlated with poorer physical and mental quality-of-life measures. Weight loss was associated with a significant and sustained fall in BDI scores, with a mean +/- SD score of 7.8 +/- 6.5 at 1 year and 9.6 +/- 7.7 at 4 years after surgery. Greater falls in BDI score at 1 year were seen in women, younger subjects, and those with greater excess weight loss (combined r2 = 0.10; P<.001). Fall in BDI score correlated with improvement in appearance evaluation (r = -0.31; P<.001). CONCLUSIONS: Severely obese subjects, especially younger women with poor body image, are at high risk for depression. We found sustained improvement with weight loss. These findings also support the hypothesis that severe obesity causes or aggravates depression.

Adult↗

A rational approach to cholelithiasis in bariatric surgery: its application to the laparoscopically placed adjustable gastric band.

BACKGROUND: Gallstones are more common in the obese population and may be formed during rapid weight loss. A rational approach to the management of the gallbladder should be incorporated into bariatric surgical practice. It has been recommended that patients undergoing Roux-en-Y gastric bypass have routine cholecystectomy regardless of gallstone status. We analyzed the outcomes of a noninterventionist policy on 1000 patients undergoing laparoscopic adjustable gastric banding. HYPOTHESIS: Patients scheduled for adjustable gastric banding should undergo investigation for and treatment of gallbladder disease regardless of symptoms. METHODS: Patients were screened preoperatively for symptoms of gallstones. Ultrasound examination was performed only in those with symptoms and, if stones were present, cholecystectomy was performed with gastric banding. The remaining patients were followed up clinically and outcomes were noted. RESULTS: A total of 1000 patients were followed up for 12 to 96 months, a total of approximately 3500 patient-years. Cholecystectomy was performed in 181 patients before and 10 at gastric banding surgery. Of the 809 patients at risk, 55 (6.8%) presented with symptomatic disease during follow-up and proceeded to undergo elective cholecystectomy without complications from the disease or the treatment. CONCLUSIONS: The incidence of cholecystectomy after gastric banding surgery was not different from the expected rate for a nonsurgical obese population. In contrast, after Roux-en-Y gastric bypass, a median of 40% of patients form stones in the postoperative period, and prophylactic cholecystectomy may be justified. Our data indicate that a noninterventionist approach to the gallbladder is appropriate for patients undergoing adjustable gastric banding surgery.

Anastomosis, Roux-en-Y↗

Pro-fibrotic polymorphisms predictive of advanced liver fibrosis in the severely obese.

BACKGROUND/AIMS: Insulin resistance and systemic hypertension are predictors of advanced fibrosis in obese patients with non-alcoholic fatty liver disease (NAFLD). Genetic factors may also be important. We hypothesize that high angiotensinogen (AT) and transforming growth factor-beta1 (TGF-beta1) producing genotypes increase the risk of liver fibrosis in obese subjects with NAFLD. METHODS: One hundred and five of 130 consecutive severely obese patients having a liver biopsy at the time of laparoscopic obesity surgery agreed to have genotype analysis. Influence of specific genotype or combination of genotypes on the stage of hepatic fibrosis was assessed after controlling for known risk factors. RESULTS: There was no fibrosis in 70 (67%), stages 1-2 in 21 (20%) and stages 3-4 fibrosis in 14 (13%) of subjects. There was no relationship between either high AT or TGF-beta1 producing genotypes alone and hepatic fibrosis after controlling for confounding factors. However, advanced hepatic fibrosis occurred in five of 13 subjects (odds ratio 5.7, 95% confidence interval 1.5-21.2, P=0.005) who inherited both high AT and TGF-beta1 producing polymorphisms. CONCLUSIONS: The combination of high AT and TGF-beta1 producing polymorphisms is associated with advanced hepatic fibrosis in obese patients with NAFLD. These findings support the hypothesis that angiotensin II stimulated TGF-beta1 production may promote hepatic fibrosis.

Adult↗

Lap-band: outcomes and results.

INTRODUCTION: Laparoscopic adjustable gastric banding was first introduced in the early 1990s as a potentially safe, controllable, and reversible method for achieving significant weight loss in the severely obese. The Bioenterics Lap-Band system (Inamed Health, Santa Barbara, California) is the device most commonly used. After 10 years of experience in treating more than 100000 patients with the Lap-Band, it is timely for us to review the outcomes. METHODS: Data for the review are derived from the experience of our unit in the treatment of 1250 patients to date, from an independent systematic review of the published literature up to September 2001, and from major studies published after the date of closure of the systematic review. RESULTS: Lap-Band placement has proved to be a very safe procedure with a mortality rate in the published reports of 1 in 2000, only 10% of the published mortality rate of gastric bypass. The early complication rate has been very low, but late complications of prolapse or erosions have been more frequent, particularly during the early experience. Weight is lost during the first 2 to 3 years after surgery. The systematic review reports 56% excess weight loss (EWL) at 5 years (three reports). In comparison, Roux-en-Y gastric bypass (RYGB) is reported to have achieved 59% EWL at 5 years (four reports). Major improvements in comorbid conditions have been reported in association with weight loss after Lap-Band placement. Most importantly, type 2 diabetes is usually cured, and insulin resistance and reduced pancreatic beta-cell function are reversed. Gastroesophageal reflux, obstructive sleep apnea, and depression are other diseases in which marked improvement is noted. Quality-of-life scores return to normal values. CONCLUSIONS: Lap-Band placement is proving to be safe and effective. In view of the attributes of adjustability, safe laparoscopic placement, and reversibility, it should be considered the optimal initial approach for the control of obesity and its comorbid conditions.

Digestive System Surgical Procedures↗

Predicting sleep apnea and excessive day sleepiness in the severely obese: indicators for polysomnography.

BACKGROUND: Obstructive sleep apnea (OSA) is common in severely obese subjects (body mass index [BMI] > 35). Overnight polysomnography (OPS) is the "gold standard" method of evaluating this condition; however, it is time-consuming, inconvenient, and expensive. Selection of patients for OPS would be enhanced if we could better predict those likely to have clinically significant OSA. STUDY OBJECTIVE: To look for clinical and biochemical predictors of OSA in symptomatic patients presenting for obesity surgery. DESIGN AND PATIENTS: Symptoms suggestive of OSA were sought in a structured interview. We report OPS results of 99 consecutive subjects in whom OSA was clinically suspected. Predictors of apnea-hypopnea index (AHI) were sought from an extensive preoperative data collection. Multivariate linear and logistic analysis was used to identify independent predictors of AHI. RESULTS: Symptoms were poor predictors of AHI, with observed sleep apnea the only positive predictor. Four clinical and two biochemical factors independently predicted AHI: observed sleep apnea, male sex, higher BMI, age, fasting insulin, and glycosylated hemoglobin A(Ic) (r(2) = 0.42). Neck circumference (the best single measure) could replace BMI and sex in the analysis (r(2) = 0.43). With cutoffs selected, a simple scoring system using these six factors provides a method of predicting those with moderate or severe OSA. A score > or = 3 provides a sensitivity and specificity of 89% and 81%, and 96% and 71% for AHIs of > or = 15 and > or = 30, respectively. None of the 31 subjects with scores of 0 or 1 were found to have an AHI > or = 15. CONCLUSION: We explore sleep disturbance and report a simple method of predicting OSA in severely obese symptomatic subjects. This should assist in limiting the use of OPS to those with greater risk and provide a method of assessing risk in those not presenting primarily with a sleep problem.

Adult↗

Cardiovascular benefit of light to moderate alcohol consumption.

BACKGROUND: In recent years strong epidemiological evidence has arisen associating significant cardiovascular benefit with light to moderate alcohol consumption. Increased benefit in high cardiovascular risk individuals has been particularly evident. With Australian levels of obesity and type 2 diabetes now reaching epidemic proportions, lifestyle factors that can reduce cardiovascular risk are of critical importance. OBJECTIVE: This article aims to inform general practitioners of the potential cardiovascular benefit of light to moderate alcohol consumption. DISCUSSION: In offering tailored alcohol advice to patients, the GP should have two goals: to minimise harm and maximise benefit. Blanket discouragement of all levels of alcohol consumption can no longer be justified.

Alcohol Drinking↗

Changes in the microvascular architecture of colorectal liver metastases following the administration of SMANCS/lipiodol.

BACKGROUND: Liver metastases are the major cause of death for patients with colorectal cancer. Surgical resection is at present the only curative option. Styrene maleic acid neocarzinostatin [SMANCS/Lipiodol (S/L)] targets the unique vascular architecture of tumor blood vessels, which are hyperpermeable and lack a well-developed lymphatic system. Here we report changes in the microvascular architecture of liver metastases by scanning electron microscopy (SEM) following the administration of S/L. MATERIALS AND METHODS: Liver metastases were induced by the intrasplenic injection of dimethylhydrazine induced colon cancer cells in mice. In this model tumor angiogenesis occurs at day 10, while exponential tumor growth occurs at day 16. Changes in the tumor microvasculature were observed at 3 weeks following treatment with S/L at these time points by SEM of corrosion casts. RESULTS: Tumors treated with S/L at day 10 appear similar to day 10 controls. Tumor vessels, 50 +/- 18 microm in diameter, are easily identified from hepatic vessels. Within the hepatic sinusoids are avascular spaces, 144 +/- 60 microm in diameter, which correspond to tumor cell aggregates at the initial stages of growth. Similarly, day 16 treated tumors appear comparable to day 16 controls. These vessels are narrower (84 +/- 32 microm vs. 150 +/- 70 microm) than their control counterparts. This is in contrast to vessels (216 +/- 36 microm in diameter) of a complex nature at 3 weeks. CONCLUSIONS: S/L exerts a marked and immediate effect on the tumor microvessels at both the angiogenic and the exponential phases of tumor growth. This agent is effective at the microvascular level during inhibition of metastatic growth.

Animals↗

The extent of the problem of obesity.

The prevalence of obesity is increasing worldwide. In the United States, in 1999, 27% of adults had a body mass index >30 kg/m(2), almost double the prevalence of 20 years earlier. The estimated mortality from obesity-related diseases in the United States is approximately 300,000 annually and growing. In the future, mortality related to obesity is expected to exceed that of smoking. Numerous diseases are caused or made worse by obesity. These include type 2 diabetes; hypertension; dyslipidemia; ischemic heart disease; stroke; obstructive sleep apnea; asthma; nonalcoholic steatohepatitis; gastroesophageal reflux disease; degenerative joint disease of the back, hips, knees, and feet; infertility and polycystic ovary syndrome; various malignancies; and depression. Type 2 diabetes is perhaps the most visible obesity-related problem. Present in at least 14 million Americans, it leads to serious complications and premature death. It is largely caused by obesity, and is generally cured by weight loss. The quality of life of the obese is markedly reduced, and the costs to health care systems are great. Preventive programs have yet to affect the rising prevalence. An effective solution is needed.

Diabetes Mellitus, Type 2↗

Selecting the optimal patient for LAP-BAND placement.

Optimal patient selection for laparoscopic adjustable gastric banding with the LAP-BAND (INAMED Health, Santa Barbara, CA) enables maximization of results for patients most suited to the procedure and avoidance of unsatisfactory outcomes for inappropriate candidates. We have investigated potential predictors of outcomes in our patients to look for associations with weight loss. We have also reviewed published data for additional predictors. This analysis has revealed a number of conditions associated with a significantly lower percent excess weight loss (%EWL) than experienced in the overall group. These include increasing age, increasing body mass index (BMI), hyperinsulinemia, insulin resistance, type 2 diabetes, and polycystic ovary syndrome. There was also less weight loss if the SF-36 quality-of-life measure showed a poor physical activity score, high pain score, or poor general health score. However, in all these conditions, the effect was small in comparison with the benefits achieved by these patients, and was judged insufficient to preclude this approach to treatment of their obesity. A number of conditions were found to have no relation to weight loss after LAP-BAND placement. These included sex, presence of mental illness, most comorbidities except those linked to insulin resistance, previous bariatric surgery, and sweet-eating behavior. The value of psychologic assessment to predict outcomes could not be established. The superobese (BMI >50) achieved a lower %EWL at 1 year after LAP-BAND placement compared with those with BMI <50, but there were no differences at the 2-, 3-, and 4-year follow-ups.

Contraindications↗

Patient management after LAP-BAND placement.

Severe obesity is a chronic disease requiring continuing care. Optimal outcomes of laparoscopic adjustable gastric banding using the LAP-BAND (INAMED Health, Santa Barbara, CA) depend on accurate placement of the band and excellent postplacement care, which requires a long-term commitment from both the patient and the bariatric surgical team. Adjustability is a key feature of the LAP-BAND system, and knowing when and how much to adjust requires careful judgment. Two methods of approaching the art of adjustment are described: the office adjustment and the radiologic adjustment. A properly placed and adjusted band produces prolonged satiety after a small meal, facilitating a major reduction in dietary intake leading to weight loss. Healthy food choices, increased activity and exercise, and the behavioral changes necessary to achieve these are essential elements of all weight loss programs. The LAP-BAND program is no exception. Follow-up requires monitoring of the comorbidities of obesity and metabolic and nutritional status. Communication and collaboration with the patient's primary care provider are important. All of the elements above are necessary to provide the comprehensive care that contributes to optimal patient outcomes.

Diet↗

Weight loss and early and late complications--the international experience.

Following its introduction in 1993, the LAP-BAND (INAMED Health, Santa Barbara, CA) has been used extensively across the world for the treatment of obesity, and data on safety and effectiveness are now available. This review draws on the literature and our own clinical patient base to provide an overview of the early and late problems associated with LAP-BAND placement and its effects on weight loss. It has proved to be a remarkably safe procedure. A report analyzing international data on laparoscopic adjustable gastric bands identified 3 deaths in 5,827 patients (approximately 1 in 2,000). In our series of 1,120 patients, there have been no deaths and no life-threatening perioperative complications. Significant early complications occurred in 17 (1.5%) of our patients; late problems have been more common, particularly during our early experience. Prolapse of the stomach through the band occurred in 125 (25%) of our first 500 patients but has occurred in only 28 (4.7%) of our last 600 patients. Erosion of the band into the stomach occurred in 34 patients (3%); all occurred in the first 500 patients. No erosions have occurred in the last 600 patients. Both problems are treated laparoscopically by removal and replacement. Combined international data show that weight loss after LAP-BAND placement is characterized by steady progressive weight loss over a 2- to 3-year period, followed by stable weight out to 6 years. This pattern reflects the benefit of adjustability. For the international series, the percent excess weight loss (%EWL) at 2 years has been between 52% and 65%. In our series, %EWL at 5 years and 6 years was 54% and 57%, respectively. The LAP-BAND is proving to be extremely safe, able to facilitate good weight loss, and able to maintain weight loss over time.

Gastroplasty↗

Changes in comorbidities and improvements in quality of life after LAP-BAND placement.

Possibly the most important outcomes of bariatric surgery involve changes in obesity-related illness, quality of life (QOL), and psychologic well-being. Dramatic improvement or resolution of serious medical comorbidity accompanies the weight loss following laparoscopic adjustable gastric banding with the LAP-BAND (INAMED Health, Santa Barbara, CA). There are major improvements in the conditions of the metabolic syndrome, which is characterized by impaired glucose tolerance, dyslipidemia, and hypertension. Improvement in insulin sensitivity and pancreatic beta-cell function associated with weight loss induces remission in the majority of type 2 diabetics and reduces the risk of others developing type 2 diabetes. Improvement in dyslipidemia is characterized by raised high-density lipoprotein cholesterol and lower triglyceride concentrations. Together with lower blood pressure, these changes provide a substantial reduction in cardiovascular risk. Other medical conditions caused or aggravated by obesity are also significantly improved, including sleep apnea, daytime sleepiness, asthma, and gastroesophageal reflux. Weight loss is associated with improved fertility and more favorable pregnancy outcomes. All aspects of QOL improve substantially, especially physical disability, and post-weight-loss QOL measures approximate those of the general population. There are also major improvements in body image and reduction in depressive illness. These changes provide perhaps the most compelling data regarding the value of LAP-BAND surgery and underlie the great satisfaction experienced by patients.

Asthma↗