Five-year attrition, active enrollment, and predictors of level of participation in the Longitudinal Assessment of Bariatric Surgery (LABS-2) study.

BACKGROUND: Reporting high-quality bariatric surgery outcomes depends on participant attrition and level of study participation among enrolled participants. OBJECTIVES: Our aims are to report participant attrition, active enrollment, and level of participation, and to evaluate pre-surgery sociodemographic, physical health, and psychosocial factors as predictors of attrition and level of participation through 5 years. SETTING: The Longitudinal Assessment of Bariatric Surgery-2 study which enrolled 2458 adults undergoing a first bariatric surgical procedure at 1 of 6 US cites from 2006 through 2009. METHODS: In-person research assessments were conducted pre-surgery and annually for five years. Extensive retention strategies including offering remote assessments (telephone, email, mail, or a combination) were fully implemented in 2009. Among living participants, including those inactivated, annual follow-up assessments were categorized as in-person, remote or missed through 5 years. RESULTS: By year 5, 1.7% of participants had died and 3.2% had withdrawn or were inactivated by the study staff; thus, attrition was 4.9% (n = 121). Controlling for site and calendar year, missed assessments increased from 14.7%-21.8% between years 1 and 2 and then stayed relatively stable (20.8%-19.6%) for years 3-5. Younger age, male sex, White race, lower body mass index, smoking, illicit drug use, and higher weight loss expectations preoperatively were independently associated with a higher likelihood of a missed versus in-person assessment across follow-up. CONCLUSION: The LABS-2 participant attrition was low. The percentage of missed assessments did not increase after year 2, perhaps due to implementation of a comprehensive retention plan. Predictors of missed assessments highlight subgroups to target for focused retention efforts.

Weight loss after bariatric surgery in cancer survivors.

BACKGROUND: With improved methods of identification and treatment, the numbers of cancer survivors are increasing. Weight loss is encouraged to reduce recurrence. After cancer treatment, will survivors respond to weight change and receive the benefits of bariatric surgery? OBJECTIVE: To compare weight loss after bariatric surgery of patients treated for cancer with those never diagnosed with cancer. SETTING: The 10 surgical centers participating in the Longitudinal Assessment of Bariatric Surgery (LABS2). METHODS: A retrospective review of the LABS database of 2458 participants was completed to determine which patients had answered the question that they had been told they had cancer with a positive response. Cancer survivors were compared for body mass index (calculated as weight in kilograms divided by height in meters squared) at baseline and 1, 3, 5, and 7 years after bariatric surgery with those who responded negatively to this question. Descriptive statistics, Fisher's exact tests, 2-sample independent t tests, Wilcoxon rank sum tests, and multiple linear regression were used. RESULTS: Groups were significantly different in age (P < .0001) and surgery type (P = .02). Other demographic and clinical comparisons were nonsignificant at the .05 significance level. Cancer survivors demonstrated less weight loss at 1 year (P = .0001). Over 7 years, there was no significant difference between the 2 groups. Adjusting for age, sex, baseline body mass index, and surgery type, cancer history was not found to be significant predictor of body mass index change 1-year postbariatric surgery. CONCLUSIONS: Patients treated for cancer are not different than the general population in their capacity for long-term weight loss with surgical assistance.

A longitudinal examination of suicide-related thoughts and behaviors among bariatric surgery patients.

BACKGROUND: Past research suggests self-harm/suicidality are more common among adults who have undergone bariatric surgery than the general population. OBJECTIVES: To compare prevalence of self-harm/suicidal ideation over time and identify presurgery risk factors for postsurgery self-harm/suicidal ideation. SETTING: The Longitudinal Assessment of Bariatric Surgery-2 is a cohort study with presurgery and annual postsurgery assessments conducted at 10 U.S. hospitals. METHODS: Adults with severe obesity undergoing bariatric surgery between March 2006 and April 2009 (n = 2458). Five-year follow-up is reported. Self-reported history of suicidality assessed retrospectively via the Suicide Behavior Questionnaire-Revised (SBQ-R) and self-reported self-harm/suicidal ideation assessed prospectively via the Beck Depression Inventory-Version 1 (BDI-1). RESULTS: The SBQ-R was completed by 1540 participants; 2217 completed the BDI-1 pre- and postsurgery. Over 75% of participants were female, with a median age of 46 years and body mass index of 45.9 kg/m2. Approximately one fourth of participants (395/1534) reported a presurgery history of suicidal thoughts or behavior (SBQ-R). The prevalence of self-harm/suicidal ideation (BDI-1) was 5.3% (95% confidence interval [CI], 3.7-6.8) presurgery and 3.8% (95% CI, 2.5-5.1) at year 1 postsurgery (P = .06). Prevalence increased over time postsurgery to 6.6% (95% CI, 4.6-8.6) at year 5 (P = .001) but was not significantly different than presurgery (P = .12). CONCLUSIONS: A large cohort of adults with severe obesity who underwent bariatric surgery had a prevalence of self-harm/suicidal ideation that may have decreased in the first postoperative year but increased over time to presurgery levels, suggesting screening for self-harm/suicidality is warranted throughout long-term postoperative care. Several risk factors were identified that may help with enhanced monitoring.

Nutrient Status 9 Years After Biliopancreatic Diversion with Duodenal Switch (BPD/DS): an Observational Study.

BACKGROUND: Since biliopancreatic diversion with duodenal switch (BPD/DS) produces hypoabsorption, evaluation of long-term nutrient changes is appropriate. METHODS: Measurements of micronutrients, trace elements, PTH, iron studies, and protein were completed for consented patients at baseline prior to surgery and at yearly intervals. The patients were advised and supplements were adjusted by blood studies with compliance checks. Independent t tests and ANOVAs compared changes between cross-sectional cohorts based on follow-up time from surgery. A p value of 0.05 was considered significant. RESULTS: Between 1999 and 2010, 284 patients had BPD/DS. At baseline, nutrient analysis was available for only 190 patients (70% women), age 42.7 ± 10.0 years, BMI 53.0 ± 11.9 kg/m2; at year 1, 189 were available; at year 3, 193; at year 5, 132; at year 7, 98; and at year 9, 68. Gender distribution was not significantly different between cohorts. Baseline vitamin D was low and PTH high. All of the patients took some supplements. Fat-soluble vitamins remained low. Protein deficiency appeared at year 3 and increased to 30% at year 9. Baseline zinc was normal, but at year 5, 45% were low. Over time, hematocrit was low for 40% and hemoglobin for 46%. Iron deficiency continued through year 9, more marked in males. Calcium deficiency increased from year 3 and remained steady. Half of the patients had abnormal PTH at baseline, and the percentage increased over time. Twenty percent had abnormal baseline magnesium values. Magnesium fluctuated during observation. CONCLUSIONS: Major deficits in nutrient status occurred and persisted after surgery although supplementation was prescribed. Interventions are mandated to avoid nutrient deficiency.

Fat-free mass is not lower 24 months postbariatric surgery than nonoperated matched controls.

OBJECTIVE: Concerns about an excessive loss of fat-free mass (FFM) after bariatric surgery prompted this comparison of operated versus matched nonoperated controls regarding FFM. SETTING: University Hospital and University Research Unit in an urban medical center. METHODS: Body composition with bioelectric impedance (Tanita 310, Tanita Corp, Arlington Heights, IL) was measured approximately 2 years after bariatric surgery in weight stable patients and nonoperated weight stable controls matched for body mass index (BMI), gender, and age. t tests provided comparisons. Analysis of variance was used to compare FFM changes for 4 procedures. Levene's test evaluated variance. RESULTS: Patients (n = 252; 24.7±15 mo after surgery) and nonoperated controls (n = 252) were matched for gender (71.8% female), age (44.5±11.0 yr), and BMI (32.8±7.0 kg/m2). Patients had different surgical procedures: 107 gastric bypasses (RYGBs), 62 biliopancreatic diversions with duodenal switch (BPD/DSs), 40 adjustable gastric bands (AGBs), and 43 sleeve gastrectomies (LSGs). FFM percentage was significantly higher in the operated patients than controls, 66% versus 62%, P<.0001. For 3 procedures, the FFM was significantly higher; however, AGBs changed only 7.3 BMI units and FFM was not significantly different from their matched controls, 59.8% versus 58.2%. Across surgical groups, FFM percentage differed, P<.0001 (RYGB 66.5±9.2%, BPD/DS 74.0±9.3%, AGB 59.8±7.0%, LSG 59.6±9.3%). Variance was not different (P = .17). CONCLUSION: Weight-reduced bariatric surgery patients have greater FFM compared with nonoperated matched controls. These findings support surgically assisted weight loss as a physiologic process and in general patients do not suffer from excessive FFM depletion after bariatric procedures.

The Impact of Biliopancreatic Diversion with Duodenal Switch (BPD/DS) Over 9 Years.

BACKGROUND: There is limited information on the multiple long-term effects of the biliopancreatic diversion with duodenal switch (BPD/DS). METHODS: Patients who consented to a BPD/DS from 1999 to 2010 were evaluated for weight change, complications, comorbidity resolution, body composition, quality of life, and depressive symptoms during visits at 1, 3,5, 7, and 9 years. Descriptive statistics, analysis of variance, and pair-wise comparisons were calculated for each of the five follow-up cohorts vs. the baseline cohort. RESULTS: Between 1999 and 2010, 284 patients received a BPD/DS; 275 patients (69.8 % women) age 42.7 years, BMI 53.4 kg/m2 qualified for baseline analysis. Two hundred seventy-five patients were available in year 1; 275 patients in year 3; 273 patients in year 5; 259 patients in year 7; and 228 patients in year 9. Gender distribution was not different. BMI was 30.1 at 1 year and 32.0 at 9 years. Body fat was reduced to 26 % after 2 years. Complications requiring surgery were significant. Nutritional problems developed in 29.8 % of patients over the course of observation. The baseline Beck Depression Index (BDI) was 13.9 and 7.2 in year 1. Year 1 through 9 remained unchanged. There were significant positive changes in quality of life between baseline and year 1 for most domains. These positive changes were maintained for the follow-up cohorts. After surgery the resolution of comorbidities continued for the 9 years. CONCLUSIONS: Weight loss during the first year was well maintained, resolving comorbidities and improving quality of life. Rates of surgical complications resemble other bariatric procedures. Long-term nutrient deficiencies are of concern.

Facilitated long chain fatty acid uptake by adipocytes remains upregulated relative to BMI for more than a year after major bariatric surgical weight loss.

OBJECTIVE: This study examined whether changes in adipocyte long chain fatty acid (LCFA) uptake kinetics explain the weight regain increasingly observed following bariatric surgery. METHODS: Three groups (10 patients each) were studied: patients without obesity (NO: BMI 24.2 ± 2.3 kg m(-2) ); patients with obesity (O: BMI 49.8 ± 11.9); and patients classified as super-obese (SO: BMI 62.6 ± 2.8). NO patients underwent omental and subcutaneous fat biopsies during clinically indicated abdominal surgeries; O were biopsied during bariatric surgery, and SO during both a sleeve gastrectomy and at another bariatric operation 16 ± 2 months later, after losing 113 ± 13 lbs. Adipocyte sizes and [(3) H]-LCFA uptake kinetics were determined in all biopsies. RESULTS: Vmax for facilitated LCFA uptake by omental adipocytes increased exponentially from 5.1 ± 0.95 to 21.3 ± 3.20 to 68.7 ± 9.45 pmol/sec/50,000 cells in NO, O, and SO patients, respectively, correlating with BMI (r = 0.99, P < 0.001). Subcutaneous results were virtually identical. By the second operation, the mean BMI (SO patients) fell significantly (P < 0.01) to 44.4 ± 2.4 kg m(-2) , similar to the O group. However, Vmax (40.6 ± 11.5) in this weight-reduced group remained ~2X that predicted from the BMI:Vmax regression among NO, O, and SO patients. CONCLUSIONS: Facilitated adipocyte LCFA uptake remains significantly upregulated ≥1 year after bariatric surgery, possibly contributing to weight regain.

Urinary Incontinence Before and After Bariatric Surgery.

IMPORTANCE: Among women and men with severe obesity, evidence for improvement in urinary incontinence beyond the first year after bariatric surgery-induced weight loss is lacking. OBJECTIVES: To examine change in urinary incontinence before and after bariatric surgery and to identify factors associated with improvement and remission among women and men in the first 3 years after bariatric surgery. DESIGN, SETTING, AND PARTICIPANTS: The Longitudinal Assessment of Bariatric Surgery 2 is an observational cohort study at 10 US hospitals in 6 geographically diverse clinical centers. Participants were recruited between February 21, 2005, and February 17, 2009. Adults undergoing first-time bariatric surgical procedures as part of clinical care by participating surgeons between March 14, 2006, and April 24, 2009, were followed up for 3 years (through October 24, 2012). INTERVENTION: Participants undergoing bariatric surgery completed research assessments before the procedure and annually thereafter. MAIN OUTCOMES AND MEASURES: The frequency and type of urinary incontinence episodes in the past 3 months were assessed using a validated questionnaire. Prevalent urinary incontinence was defined as at least weekly urinary incontinence episodes, and remission was defined as change from prevalent urinary incontinence at baseline to less than weekly urinary incontinence episodes at follow-up. RESULTS: Of 2458 participants, 1987 (80.8%) completed baseline and follow-up assessments. At baseline, the median age was 47 years (age range, 18-78 years), the median body mass index was 46 kg/m2 (range, 34-94 kg/m2), and 1565 of 1987 (78.8%) were women. Urinary incontinence was more prevalent among women (49.3%; 95% CI, 46.9%-51.9%) than men (21.8%; 95% CI, 18.2%-26.1%) (P < .001). After a mean 1-year weight loss of 29.5% (95% CI, 29.0%-30.1%) in women and 27.0% (95% CI, 25.9%-28.6%) in men, year 1 urinary incontinence prevalence was significantly lower among women (18.3%; 95% CI, 16.4%-20.4%) and men (9.8%; 95% CI, 7.2%-13.4%) (P < .001 for all). The 3-year prevalence was higher than the 1-year prevalence for both sexes (24.8%; 95% CI, 21.8%-26.5% among women and 12.2%; 95% CI, 9.0%-16.4% among men) but was substantially lower than baseline (P < .001 for all). Weight loss was independently related to urinary incontinence remission (relative risk, 1.08; 95% CI, 1.06-1.10 in women and 1.07; 95% CI, 1.02-1.13 in men) per 5% weight loss, as were younger age and the absence of a severe walking limitation. CONCLUSIONS AND RELEVANCE: Among women and men with severe obesity, bariatric surgery was associated with substantially reduced urinary incontinence over 3 years. Improvement in urinary incontinence may be an important benefit of bariatric surgery.

Lipid profile changes in the severely obese after laparoscopic sleeve gastrectomy (LSG), 1, 3, and 5 years after surgery.

BACKGROUND: Since there is an increasing acceptance of the laparoscopic sleeve gastrectomy (LSG) and limited information regarding its effect on cardiac risk factors, we assessed lipid profiles. METHODS: A retrospective review of patient records pre and post LSG was performed. Analysis of variance evaluated group differences and paired t tests compared variable changes. RESULTS: Eighty two patients (67 % female, age 46.4 ± 13.9) had presurgery lipid profiles and follow-up (43 at 1 year, 28 at 3 years, and 26 at 5 years). Groups were not different in gender distribution. The presurgery mean body mass index (BMI) was 55.7 kg/m(2); 65.9 % of the subjects were super obese. After surgery, percentage of excess BMI loss was 58.1 % year (yr) 1, 61.3 % yr 3, and 39.0 % yr 5. Lipids were within the normal ranges for all parameters at all times; however, at baseline 77 % had at least one abnormality. At 1 year, triglycerides decreased significantly from baseline (adjusted p value (adj-p) = 0.004) and high-density lipoprotein (HDL) increased (adj-p = 0.025). Year 3 HDL was significantly different from baseline, adj-p = 0.0001. Yr 3 cholesterol increased from baseline, (adj-p = 0.027). Negative linear correlations with weight loss were present for low-density lipoprotein (LDL) at yr 3(r = 0.46, p = 0.02) and triglyceride change at year 5 (r = 0.48, p = 0.02). The percentage of patients with dyslipidemia or medicated did not change significantly during these 5 years. CONCLUSIONS: For this population electing LSG, mean lipid profiles were within normal ranges for all parameters before surgery. However, 77 % showed at least one abnormality presurgery. Weight change correlated with some changes of triglycerides, HDL, and LDL over time, but the impact was limited.

Longitudinal Assessment of Bariatric Surgery (LABS): retention strategy and results at 24 months.

BACKGROUND: Retaining participants in observational longitudinal studies after bariatric surgery is difficult yet critical because the retention rate affects interpretation and generalizability of results. Strategies for keeping participants involved in such studies are not commonly published. The objective of this study was to review LABS retention strategies and present the 24-month retention data. METHODS: The LABS Consortium monitors an observational cohort study of 2458 adults enrolled before bariatric surgery at 10 centers within the United States (LABS-2). To maximize data completeness, the investigators developed retention strategies, including flexible scheduling, a call protocol, reminder letters, abbreviated visit options, honoraria, travel reimbursement, providing research progress reports, laboratory results, newsletters, study website, and retention surveys. Strategies for locating participants included frequent updates of contact information, sending registered letters, and searching medical and public records. RESULTS: At 12 and 24 months, 2426 and 2405 participants remained active, with vital status known for 98.7% and 97.3% and weight obtained for 95.2% and 92.2%, respectively. There were 148 missed visits (6.2%) at 24 months primarily because of inability to contact the participant. Only 15 (0.6%) active participants at 24 months missed all follow-up visits. Although 42 participants could not be located or contacted at 6 months, data were obtained for 23 (54.7%) of them at 12 months, and of the 52 participants who could not be located or contacted at 12 months, data were obtained for 18 (34.6%) at 24 months. CONCLUSION: Longitudinal studies provide the ability to evaluate long-term effects of bariatric surgical procedures. The retention achieved in LABS is superior to that of many published reports but requires extensive effort and resources. This report identifies useful retention strategies. Further research is needed to identify the efficacy and cost-effectiveness of specific retention strategies.