Cheryl Laurie

Laparoscopic Adjustable Gastric Banding in Severely Obese Adolescents: A Randomized Trial

CONTEXT Adolescent obesity is a common and serious health problem affecting more than 5 million young people in the United States alone. Bariatric surgery is being evaluated as a possible treatment option. Laparoscopic adjustable gastric banding (gastric banding) has the potential to provide a safe and effective treatment. OBJECTIVE To compare the outcomes of gastric banding with an optimal lifestyle program on adolescent obesity. DESIGN, SETTING, AND PATIENTS A prospective, randomized controlled trial of 50 adolescents between 14 and 18 years with a body mass index (BMI) higher than 35, recruited from the Melbourne, Australia, community, assigned either to a supervised lifestyle intervention or to undergo gastric banding, and followed up for 2 years. The study was performed between May 2005 and September 2008. MAIN OUTCOME MEASURES Weight loss. Secondary outcomes included change in metabolic syndrome, insulin resistance, quality of life, and adverse outcomes. RESULTS Twenty-four of 25 patients in the gastric banding group and 18 of 25 in lifestyle group completed the study. Twenty-one (84%) in the gastric banding and 3 (12%) in the lifestyle groups lost more than 50% of excess weight, corrected for age. Overall, the mean changes in the gastric banding group were a weight loss of 34.6 kg (95% CI, 30.2-39.0), representing an excess weight loss of 78.8% (95% CI, 66.6%-91.0%), 12.7 BMI units (95% CI, 11.3-14.2), and a BMI z score change from 2.39 (95% CI, 2.05-2.73) to 1.32 (95% CI, 0.98-1.66). The mean losses in the lifestyle group were 3.0 kg (95% CI, 2.1-8.1), representing excess weight loss of 13.2% (95% CI, 2.6%-21.0%), 1.3 BMI units (95% CI, 0.4-2.9), and a BMI z score change from 2.41 (95% CI, 2.21-2.66) to 2.26 (95% CI, 1.91-2.43). At entry, 9 participants (36%) in the gastric banding group and 10 (40%) in the lifestyle group had the metabolic syndrome. At 24 months, none of the gastric banding group had the metabolic syndrome (P = .008; McNemar chi(2)) compared with 4 of the 18 completers (22%) in the lifestyle group (P = .13). The gastric banding group experienced improved quality of life with no perioperative adverse events. However, 8 operations (33%) were required in 7 patients for revisional procedures either for proximal pouch dilatation or tubing injury during follow-up. CONCLUSIONS Among obese adolescent participants, use of gastric banding compared with lifestyle intervention resulted in a greater percentage achieving a loss of 50% of excess weight, corrected for age. There were associated benefits to health and quality of life. TRIAL REGISTRATION ANZCTR Identifier: 12605000160639.

Preoxygenation Is More Effective in the 25° Head-up Position Than in the Supine Position in Severely Obese Patients: A Randomized Controlled Study

Background:Class III obese patients have altered respiratory mechanics, which are further impaired in the supine position. The authors explored the hypothesis that preoxygenation in the 25° head-up position allows a greater safety margin for induction of anesthesia than the supine position. Methods:A randomized controlled trial measured oxygen saturation and the desaturation safety period after 3 min of preoxygenation in 42 consecutive (male:female 13:29) severely obese (body mass index > 40 kg/m2) patients who were undergoing laparoscopic adjustable gastric band surgery and were randomly assigned to the supine position or the 25° head-up position. Serial arterial blood gases were taken before and after preoxygenation and 90 s after induction. After induction, ventilation was delayed until blood oxygen saturation reached 92%, and this desaturation safety period was recorded. Results:The mean body mass indexes for the supine and 25° head-up groups were 47.3 and 44.9 kg/m2, respectively (P = 0.18). The group randomly assigned to the 25° head-up position achieved higher preinduction oxygen tensions (442 ± 104 vs. 360 ± 99 mmHg; P = 0.012) and took longer to reach an oxygen saturation of 92% (201 ± 55 vs. 155 ± 69 s; P = 0.023). There was a strong positive correlation between the induction oxygen tension achieved and the time to reach an oxygen saturation of 92% (r = 0.51, P = 0.001). There were no adverse events associated with the study. Conclusion:Preoxygenation in the 25° head-up position achieves 23% higher oxygen tensions, allowing a clinically significant increase in the desaturation safety period—greater time for intubation and airway control. Induction in the 25° head-up position may provide a greater safety margin for airway control.

A Prospective Randomized Trial of Placement of the Laparoscopic Adjustable Gastric Band: Comparison of the Perigastric and Pars Flaccida Pathways

Background: Laparoscopic adjustable gastric banding (LAGB) is a safe and effective method for the treatment of obesity. The most common problem after LAGB has been the occurrence of prolapse (slippage) of the stomach through the band. It has been proposed that the pars flaccida (PF) pathway (dissection from the base of the right crus, along the left crus to the angle of His) is less likely to be associated with prolapse than the traditional perigastric (PG) pathway (dissection between the lesser curvature of stomach and lesser omentum, across the apex of the lesser sac, to the angle of His). We have tested this hypothesis using a randomized controlled trial format. Methods: We have performed a randomized controlled trial to compare the outcomes after LAGB using PF and PG pathways. 202 patients (mean age 40 years, mean weight 123 kg, mean BMI 45) were randomly allocated to the PF or PG pathway and followed for 2 years. Results: At 24 months, there have been 16 revisional procedures for prolapse, 4 in the PF group (all anterior prolapse) and 15 in the PG group (12 posterior and 3 anterior). This difference is significant (P<0.001). The mean % excess weight lost was 53% for the PF group and 46% for the PG group. There was equally significant improvements in the metabolic syndrome in both groups (59% preoperatively and 19% at 2 years). All 8 paired domain scores of the SF-36 measures of quality of life were improved significantly in both group (P<0.001). Conclusions: The PF pathway is as effective as the PG pathway in generating substantial weight loss, improved health and improved quality of life and is significantly less likely to be associated with prolapse (slippage). It is recommended as the primary dissection pathway.

Substantial Intentional Weight Loss and Mortality in the Severely Obese

Objective:To compare all-cause mortality in a surgical weight loss cohort with a similarly aged, obese population-based cohort. Summary Background Data:Significant weight loss following bariatric surgery improves the comorbidities associated with obesity. Improved survival as a result of surgical weight loss has yet to be clearly demonstrated using clinical data. Methods:The surgical weight loss cohort was a series of consecutive patients treated with a laparoscopic adjustable gastric band in Melbourne between June 1994 and April 2005. The Melbourne Collaborative Cohort Study (MCCS) provided a community control cohort, recruited between 1992 and 1994 and followed to June 2005 to determine vital status. Height and weight were recorded at baseline in both studies. Subjects between 37 and 70 years and with a body mass index (BMI) of ≥35 were included. Vital status was determined by follow-up and searching of death registries. Survival time was compared using Kaplan-Meier estimates, and hazard of death was determined using Cox regression, adjusting for sex, age at baseline, and BMI at baseline. Results:Of 966 weight loss patients (mean age 47 years, mean BMI 45 kg/m2), the median follow-up time was 4 years. Mean weight loss after 2 years was 22.8% ± 9% (58% of excess weight). The MCCS cohort included 2119 severely obese members (mean age, 55 years; mean BMI, 38 kg/m2; median follow-up time, 12 years). There were 4 deaths in the weight loss cohort and 225 deaths in the MCCS cohort. Weight loss patients had 72% lower hazard of death than the community control cohort (hazard ratio, 0.28; 95% confidence interval, 0.10–0.85). Conclusions:Substantial surgical weight loss in a morbidly obese population was associated with a significant survival advantage.

Patient Motivation for Bariatric Surgery: Characteristics and Impact on Outcomes

Background: Motivation for seeking obesity surgery has not been studied. The authors explored the patients 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/m2 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/m2, 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 patients primary motivating factor.

Changes in Body Composition with Weight Loss: Obese Subjects Randomized to Surgical and Medical Programs

Objective: To assess changes in body composition with weight loss in obese subjects randomized to a laparoscopic adjustable gastric band surgical program or a medical program using a very‐low‐energy diet and orlistat.

Multidisciplinary diabetes care with and without bariatric surgery in overweight people: a randomised controlled trial.

BACKGROUND Bariatric surgery improves glycaemia in obese people with type 2 diabetes, but its effects are uncertain in overweight people with this disease. We aimed to identify whether laparoscopic adjustable gastric band surgery can improve glucose control in people with type 2 diabetes who were overweight but not obese. METHODS We did an open-label, parallel-group, randomised controlled trial between Nov 1, 2009, and June 30, 2013, at one centre in Melbourne, Australia. Patients aged 18-65 years with type 2 diabetes and a BMI between 25 and 30 kg/m2 were randomly assigned (1:1), by computer-generated random sequence, to receive either multidisciplinary diabetes care plus laparoscopic adjustable gastric band surgery or multidisciplinary diabetes care alone. The primary outcome was diabetes remission 2 years after randomisation, defined as glucose concentrations of less than 7.0 mmol/L when fasting and less than 11.1 mmol/L 2 h after 75 g oral glucose, at least two days after stopping glucose-lowering drugs. Analysis was by intention to treat. This trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12609000286246. FINDINGS 51 patients were randomised to the multidisciplinary care plus gastric band group (n=25) or the multidisciplinary care only group (n=26), of whom 23 participants and 25 participants, respectively, completed follow-up to 2 years. 12 (52%) participants in the multidisciplinary care plus gastric band group and two (8%) participants in the multidisciplinary care only group achieved diabetes remission (difference in proportions 0.44, 95% CI 0.17-0.71; p=0.0012). One (4%) participant in the gastric band group needed revisional surgery and four others (17%) had a total of five episodes of food intolerance due to excessive adjustment of the band. INTERPRETATION When added to multidisciplinary care, laparoscopic adjustable gastric band surgery for overweight people with type 2 diabetes improves glycaemic control with an acceptable adverse event profile. Laparoscopic adjustable gastric band surgery is a reasonable treatment option for this population. FUNDING Monash University Centre for Obesity Research and Education and Allergan.

A Prospective, Randomized, Controlled Clinical Trial of Placement of the Artificial Bowel Sphincter (Acticon Neosphincter) for the Control of Fecal Incontinence

BACKGROUNDSevere 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.METHODSFourteen 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.RESULTSIn 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.CONCLUSIONSThrough 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.

Pathophysiology of Laparoscopic Adjustable Gastric Bands: Analysis and Classification Using High-Resolution Video Manometry and a Stress Barium Protocol

BackgroundSymmetrical pouch dilatation has become the most common problem following laparoscopic adjustable gastric banding (LAGB). Although, in a significant number of symptomatic patients, no explanation for the underlying problem is identified with a contrast swallow. There is a need for a better understanding of the pathophysiology of LAGBs and more sensitive diagnostic tests.MethodsLAGB patients with adverse symptoms or poor weight loss (symptomatic patients), in whom a contrast swallow had not shown an abnormality, underwent high-resolution video manometry. This incorporated a semi-solid, stress barium, swallow protocol. Outcomes were categorized based on anatomical appearance, transit through the LAGB, and esophageal motility. Cohorts of successful (>50% excess weight loss with no adverse symptoms) and pre-operative patients were used as controls.ResultsOne hundred twenty-three symptomatic patients participated along with 30 successful and 56 pre-operative patients. Five pathophysiological patterns were defined: transhiatal enlargement (n = 40), sub-diaphragmatic enlargement (n = 39), no abnormality (n = 30), aperistaltic esophagus (n = 7), and intermittent gastric prolapse (n = 3). Esophageal motility disorders were more common in symptomatic and pre-operative patients than in successful patients (p = 0.01). Differences between successful and symptomatic patients were identified in terms of the length of the high-pressure zone above the LAGB (p < 0.005), peristaltic velocity (p < 0.005), frequency of previous surgery(p = 0.01), and lower esophageal sphincter tone (p = 0.05).ConclusionsVideo manometry identified abnormalities in three quarters of symptomatic patients where conventional contrast swallow had not been diagnostic. Five primary patterns of pathophysiology were defined. These were used to develop a seven category, clinical, classification system based on the anatomical appearance at stress barium. This system stratifies the spectrum of symmetrical pouch dilatation and can be used to logically guide treatment.

Criteria for Assessing Esophageal Motility in Laparoscopic Adjustable Gastric Band Patients: The Importance of the Lower Esophageal Contractile Segment

BackgroundEsophageal function appears critical in laparoscopic adjustable gastric band (LAGB) patients; however, conventional motility assessments have not proven to be clinically useful. Recent combined video fluoroscopic and high-resolution manometric studies have identified important components of esophageal function in LAGB patients.MethodsSuccessful and symptomatic LAGB patients, with normal or mildly impaired esophageal peristalsis, underwent a standardized, water swallow, high-resolution manometry protocol designed specifically to assess the lower esophageal contractile segment (LECS), in combination with conventional measures of esophageal motility. Differences in response to changes in LAGB volume were assessed.ResultsThere were 101 symptomatic and 29 successful patients. More symptomatic patients had a mild impairment in esophageal motility (39.6% vs. 3.4%, p < 0.005). Successful patients demonstrated an intact LECS during normal swallows more frequently than symptomatic patients (95% vs. 43%, p < 0.005). Absolute intraluminal pressures were not different between the groups. Removing all fluid from the LAGB revealed more hypotensive swallows in the symptomatic patients (30% vs. 17%, p = 0.002), an effect not observed when the LAGB volume was increased (8% vs. 5%, p = 0.21). Receiver operator characteristic analysis determined that an intact LECS in 70% of normal swallows defined normal motility in LAGB patients.ConclusionsThe LECS is a valuable measure of esophageal function in LAGB patients and complements conventional manometric criteria. Symptomatic patients have less normal swallows; however, these also frequently demonstrate a deficient LECS. Further information can be elucidated by performing swallows at differing LAGB volumes. High-resolution manometry, using these adapted criteria, is now a useful in the investigation in symptomatic LAGB patients.