Abstract
Importance
Severe obesity in childhood is a major health problem with few effective treatments. Weight loss surgery (WLS) is being used to treat severely obese adolescents, although with very limited data regarding surgical safety for currently used, minimally-invasive procedures.
Objective
To assess preoperative clinical characteristics perioperative safety outcomes of severely obese adolescents undergoing WLS.
Design
This prospective, multi-site observational study enrolled from 2007 through 2012.
Setting
This study was conducted at 5 academic referral centers in the U.S
Participants
Consecutive subjects ≤ age 19 years who were approved to undergo (n=277) were offered enrollment into the study; 13 declined participation and 22 did not undergo surgery after enrollment thus the final analysis cohort consisted of 242 individuals. There were no withdrawals.
Main Outcomes & Measures
This analysis examined preoperative anthropometrics, comorbid conditions, and major and minor complications occurring within 30 days of operation. All data were collected in a standardized fashion. Re-operations and hospital re-admissions were adjudicated by independent reviewers to assess relatedness to the WLS procedure.
Results
Mean age of participants was 17.1±1.6 years and the median BMI was 50.5 kg/m2. Fifty-one percent demonstrated four or more major co-morbid conditions. Laparoscopic Roux-en-Y gastric bypass, vertical sleeve gastrectomy, and adjustable gastric banding were performed in 66%, 28%, and 6% of subjects, respectively. There were no deaths during the initial hospitalization or within 30 days of operation; major complications (eg., reoperation) were seen in 19 subjects (8%). Minor complications (eg., readmission for dehydration) were noted in 36 subjects (15%). All re-operations and 85% of re-admissions were related to WLS.
Conclusions & Relevance
In this series, adolescents with severe obesity presented with abundant comorbid conditions. We observed a favorable short-term complication profile, supporting the early postoperative safety of WLS in select adolescents. Further longitudinal study of this cohort will permit accurate assessment of long-term outcomes for adolescents undergoing bariatric surgery.
INTRODUCTION
Obesity threatens the health and welfare of millions of children and adolescents, particularly the estimated 4-7% of youth who are considered severely obese1,2. Non-surgical weight loss interventions rarely result in substantial and sustained BMI reduction or resolution of co-morbidities for those who are severely obese3. The increased prevalence of obesity in children has been accompanied by an increased prevalence of obesity-related co-morbidities at much younger ages than in the past, including diabetes mellitus, hypertension, dyslipidemia, and non-alcoholic fatty liver disease (NAFLD) 4,5. The increase in severe obesity-related co-morbidities in adolescents, coupled with the present ineffectiveness of non-surgical therapies, have resulted in increased acceptance of weight loss surgery (WLS) as a treatment option during adolescence 6,7.
The volume of adolescent WLS in the U.S. tripled from the late 1990s to 2003 8 and shows no decline9. Initial data suggest that WLS can be offered to adolescents with a reasonable expectation of safety 8,10-12. However, few prospective or comprehensive studies have been performed to define the comorbidities, outcomes, and safety of bariatric surgery in adolescents 6,13. Existing reports detailing risks of adolescent bariatric surgery have been almost exclusively retrospective analyses of large administrative datasets 8,10-12,14, retrospective small single-institutional studies 15, and small prospective studies6,13,16, all without standardization of outcome definitions and research methodology 3.
To address important knowledge gaps pertaining to outcomes of adolescent bariatric surgery, the Teen-LABS study (NCT00474318) was designed to collect standardized prospective pre- and postoperative clinical and laboratory data longitudinally on adolescents undergoing WLS at five U.S. centers. In this report, baseline clinical characteristics and 30-day complications were analyzed.
METHODS
Study Design and Subjects
Teen-LABS was designed as an ancillary study to the Longitudinal Assessment of Bariatric Surgery study (LABS, NCT00465829) and study methodology has been briefly described 17. Consecutive adolescents (age ≤19 years) undergoing bariatric surgery at each of five Teen-LABS centers between March 2007 and February 2012 were offered enrollment. Medical and surgical care was provided for each patient as specified by patient care pathways at each institution. No attempts were made to standardize or alter care within this observational research protocol. However, clinical decision-making at centers followed accepted guidelines including indications for operation and pre- and postoperative management18. All bariatric procedures were performed by surgeons who were specifically trained for study data collection (Teen-LABS-certified surgeons). The study protocol, assent/consent forms, and data and safety monitoring plans were approved by the IRBs of each institution and by the independent data and safety monitoring board prior to study initiation.
Collection of Data
The standardized methodology developed for the LABS-2 study by the LABS consortium 19,20 was modified for an adolescent cohort. Written, informed consent was obtained from subjects who were 18 or 19 years of age; written permission was obtained from caregivers and assent from the adolescent if adolescent was <18. Subjects self-reported race/ethnicity. Pre-operative data were collected within 30 days of operation at an in-person visit with trained study personnel. A Teen-LABS-certified clinical coordinator or surgical investigator followed standard definitions to determine presence or absence of each co-morbid condition using medical records, physical exam, patient interview, and laboratory values. Detailed descriptions of study methodology, co-morbidity and other data definitions, case report forms (eCRFs), and laboratory testing are included in the online methodology supplement (eMethods).
Complications
Perioperative period
Events designated as major complications in the perioperative period included those which: were life-threatening, had potential for permanent harm, resulted in organ loss (e.g., splenic injury resulting in splenectomy), led to re-operation or blood transfusion, or which represented a major deviation in anesthetic or operative management. Minor complications included unplanned perioperative events (e.g., liver or splenic laceration, mesenteric hematoma, anastomotic revision at the time of primary operation, injury to adjacent structures), additional testing, specific medical management, non-oral enteral feedings at the time of discharge, or use of any parenteral nutrition at the time of discharge.
Discharge to 30 days postoperative period
Between discharge and 30 days following surgery (postoperative), events which were life-threatening, or had potential for permanent harm (e.g., anticoagulation for pulmonary embolus or deep vein thrombosis), or which required abdominal re-operation (including contained gastrointestinal [GI] leaks) were considered major complications. In contrast, events requiring outpatient percutaneous or endoscopic intervention, any use of non-oral enteral feeds or parenteral nutrition at 30 days after operation, or any event requiring re-admission for inpatient management (without reoperation/intervention) were considered minor complications.
All re-operations and re-admissions were analyzed by the Teen-LABS Adjudication Committee by review of the medical records and study data to determine relationship to the WLS (see online methodologic supplement).
Statistical analyses
Categorical descriptive measures were presented using frequencies and percentages. Continuous variables were summarized using measures of central tendency and dispersion. Rates of minor and major events were calculated as the number of subjects with such complications within 30 days of surgery, divided by the total number of subjects (multiplied by 100%). Subjects with major and minor events were only included in major complication calculations. Event estimates were calculated for the entire cohort and by procedure type. Exact binomial 95% confidence intervals were calculated for these measures. Event counts of each complication were also tabulated. Statistical analyses were conducted using SAS v9.3; all reported p-values were two-sided.
RESULTS
Baseline characteristics
Two hundred, seventy-seven patients were offered enrollment in this study. However, 13 declined study participation and 22 did not undergo operation by the study-imposed deadline, leaving a final analysis cohort of 242 subjects. The 242 final study subjects were similar in terms of BMI, age, and race/ethnicity to the 35 who were not studied. However, compared to the 35 not studied, the final analysis cohort was more likely to be female (p = 0.04). The 242 subjects who underwent a primary WLS procedure had a mean age of 17.1 years at surgery, a median BMI of 50.5 kg/m2, and a median waist circumference of 145.9 cm at baseline (Table 1). Twenty-one percent had a BMI greater than 60 kg/m2 at the time of study enrollment. The cohort was primarily non-Hispanic (93%), Caucasian (72%), and female (76%).
Table 1.
Demographic, anthropometric, and procedural characteristics for the 242 participants
| Age at Operation (years) | |
| Mean (SD)* | 17.1 (1.56) |
| Age group % (N) | |
| 13-15 years | 26.9% (65) |
| 16-17 years | 37.6% (91) |
| 18-19 years | 35.5% (86) |
| Body Mass Index (BMI) | |
| Median (IQR)(Min,Max) | 50.5 (45.2, 58.3)(34.0,87.7) |
| BMI group % (N) | |
| < 40 kg/m2 | 2.5% (6) |
| 40-49 kg/m2 | 45.0% (109) |
| 50-59 kg/m2 | 31.8% (77) |
| ≥ 60 kg/m2 | 20.7% (50) |
| Female % (N) | |
| 75.6% (183) | |
| Race % (N) | |
| White | 71.9% (174) |
| Black | 22.3% (54) |
| Asian | 0.4% (1) |
| American Indian or Alaskan native | 0.4% (1) |
| More than 1 race | 5.0% (12) |
| Hispanic % (N) | |
| 7.0% (17) | |
| Waist Circumference (cm) | |
| Median (IQR)(Min,Max) | 145.9 (136.3, 157.8)(112.8,194.0) |
| Sagittal Abdominal Diameter (cm) | |
| Mean (SD) | 31.7 (4.01) |
| Surgical Procedure % (N) | |
| RYGB | 66.5% (161) |
| Band | 5.8% (14) |
| VSG | 27.7% (67) |
SD, standard deviation
** IQR, interquartile range
RYGB, roux en Y gastric bypass; AGB, Adjustable gastric band; VSG, vertical sleeve gastrectomy
Approximately one half (49%) of subjects presented with 3 or fewer co-morbid conditions (conditions listed in Table 2), 39% presented with 4 or 5, and 12% presented with 6 or more co-morbid conditions. The most commonly observed comorbidities were dyslipidemia (74%), sleep apnea (57%), back and joint pain (46%), hypertension (45%), and fatty liver disease (37%; Table 2). The most common abnormal laboratory values (not adjusted for medication use) were elevated C-reactive protein (75%), hyperinsulinemia (71%), low HDL (64%), and hypertriglyceridemia (40%; eTables 1 and 2).
Table 2.
Baseline co-morbidities & conditions
| % | N | |
|---|---|---|
| Dyslipidemia | 74.4 | 180 |
| Sleep Apnea | 56.6 | 137 |
| Joint Pain* | 45.6 | 110 |
| Hypertension | 45.0 | 109 |
| Back Pain* | 45.2 | 109 |
| Fatty liver disease* | 36.9 | 89 |
| PCOS** (females only) | 20.9 | 38 |
| Chronic Kidney Disease (any stage)‡ | 19.2 | 43 |
| Diabetes | 13.6 | 33 |
| Blount's Disease | 3.7 | 9 |
| Pseudotumor cerebri | 2.5 | 6 |
Denominator = 241 (lower than 242 due to missing data)
PCOS, polycystic ovary syndrome
Denominator = 224 (lower than 242 due to missing laboratory data)
Microalbuminuria was detected in 17.7% of subjects, while 13.4%, 2.7%, and 3.1% met criteria21 for chronic kidney disease (CKD) stages 1, 2, and 3, respectively. No subject met criteria for CKD stage 4 or 5.
Surgical findings
The most common operative procedure performed was Roux-en-Y gastric bypass (RYGB) followed by vertical sleeve gastrectomy (VSG) and adjustable gastric banding (AGB; Table 1). There was a shift in procedure use over time, with a relative increase in patients undergoing VSG and decrease in AGB. (Figure 1).
Figure 1.
The trend in utilization of the three surgical procedures over time is shown.
Within 30 days of surgery, a total of 19 subjects (7.9%) experienced 20 major complications and 36 (14.9%) experienced 47 minor complications. There were no deaths. Procedure-specific rates of subjects with major complications were as follows: RYGB, 9.3% (95% CI: 5.3, 14.9); VSG, 4.5% (95% CI: 0.9, 12.5); AGB, 7.1% (95% CI: 0.2, 33.9). Comparable rates for minor events were: RYGB, 16.8% (95% CI: 11.4, 23.5); VSG, 11.9% (95% CI: 5.3, 22.2); AGB, 7.1% (95% CI: 0.2, 33.9).
Most of the major and minor complications occurred prior to discharge from the hospital (perioperatively; Table 3). Twelve subjects (5.0%) experienced 13 major perioperative complications including one intraoperative splenic injury requiring conversion to an open procedure for splenectomy; 7 of these 12 underwent early re-operation for intestinal obstruction, bleeding, and confirmed or suspected GI leak (Table 3). Nineteen subjects (7.9%) experienced 20 minor perioperative complications, including 4 minor injuries to solid organs at operation and 6 urinary tract events (infections and complications of urethral catheterization).
Table 3.
Characteristics and complications* in perioperative period
| % (N) | Bypass | Band | Sleeve | Total |
|---|---|---|---|---|
| Characteristics | (n=161) | (n=14) | (n=67) | (N=242) |
| Length of stay (days) | ||||
| Median (Interquartile range) | 3.0 (2,4) | 1.0 (1,2) | 3.0 (3,4) | 3.0 (2, 4) |
| Operative Technique | N | |||
| Laparoscopic | 99.4 (160) | 100.0 (14) | 100.0 (67) | 99.6 (241) |
| Laparoscopic converted to open | 0.6 (1) | 0.0 (0) | 0.0 (0) | 0.4 (1) |
| Open | 0.0 (0) | 0.0 (0) | 0.0 (0) | 0.0 (0) |
| Perioperative Complications | ||||
| Major complications | ||||
| Reoperation for bowel obstruction/bleeding | 1.9 (3) | 0.0 (0) | 0.0 (0) | 1.2 (3) |
| Reoperation for GI leak/sepsis | 1.2 (2) | 0.0 (0) | 1.5 (1) | 1.2 (3) |
| Reoperation for suspected sepsis | 0.6 (1) | 0.0 (0) | 0.0 (0) | 0.4 (1) |
| Postoperative bleeding – transfusion required | 2.5 (4) | 0.0 (0) | 0.0 (0) | 1.7 (4) |
| Anticoagulation therapy for DVT | 0.6 (1) | 0.0 (0) | 0.0 (0) | 0.4 (1) |
| Unplanned splenectomy for injury | 0.6 (1) | 0.0 (0) | 0.0 (0) | 0.4 (1) |
| Minor complications | ||||
| GI leak – minimal | 0.6 (1) | 0.0 (0) | 0.0 (0) | 0.4 (1) |
| Postoperative bleeding – no transfusion | 1.2 (2) | 0.0 (0) | 0.0 (0) | 0.8 (2) |
| Atelectasis/pneumonia | 0.6 (1) | 0.0 (0) | 1.5 (1) | 0.8 (2) |
| Urinary tract events | 3.1 (5) | 0.0 (0) | 1.5 (1) | 2.5 (6) |
| Bowel injury | 0.6 (1) | 0.0 (0) | 0.0 (0) | 0.4 (1) |
| Solid organ injury | 0.6 (1) | 7.1 (1) | 3.0 (2) | 1.7 (4) |
| Mesenteric bleeding/hematoma | 1.2 (2) | 0.0 (0) | 0.0 (0) | 0.8 (2) |
| Over sedation | 0.0 (0) | 0.0 (0) | 1.5 (1) | 0.4 (1) |
| Hypertension | 0.0 (0) | 0.0 (0) | 1.5 (1) | 0.4 (1) |
Perioperative complications were categorized into major (life threatening events) and minor (non-life threatening but unplanned events) types. The percentage of total participants with one or more of these complications is shown.
Post-discharge, 7 subjects (2.9%) experienced 7 major complications and 27 (11.2%) experienced 27 minor complications (Table 4). Major complications included two subjects with pulmonary embolus which were treated and resolved, two instances of GI leak that did not require intervention, one leak that required drain/stent placement, one leak that required subsequent abdominal operations, and one instance of suicidal ideation without physical harm. Among the 27 minor complications, 11 subjects had abdominal/gastrointestinal complaints and dehydration, while five subjects required upper endoscopy (Table 4).
Table 4.
Postoperative Characteristics and Complications* between discharge and 30 days
| % (N) | Bypass | Band | Sleeve | Total |
|---|---|---|---|---|
| (n=161) | (n=14) | (n=67) | (N=242) | |
| Deaths | 0.0 (0) | 0.0 (0) | 0.0 (0) | 0.0 (0) |
| Discharge location – Home | 100.0 (161) | 100.0 (14) | 100.0 (67) | 100.0 (242) |
| Major complications | ||||
| Anticoagulation therapy for pulmonary embolus | 0.6 (1) | 7.1 (1) | 0.0 (0) | 0.8 (2) |
| GI leaks not requiring reoperation | 1.2 (2) | 0.0 (0) | 0.0 (0) | 0.8 (2) |
| Suicidal ideation | 0.0 (0) | 0.0 (0) | 1.5 (1) | 0.4 (1) |
| GI leaks requiring reoperation | 0.6 (1) | 0.0 (0) | 1.5 (1) | 0.8 (2) |
| Minor complications | ||||
| Any TPN or enteral feeds after discharge | 0.0 (0) | 0.0 (0) | 1.5 (1) | 0.4 (1) |
| Gastrojejunal anastomotic stricture | 3.7 (6) | 0.0 (0) | 0.0 (0) | 2.5 (6) |
| Wound infection | 1.9 (3) | 0.0 (0) | 3.0 (2) | 2.1 (5) |
| Small bowel obstruction / Ileus | 0.6 (1) | 7.1 (1) | 0.0 (0) | 0.8 (2) |
| Abdominal pain/dehydration/diarrhea/nausea | 5.6 (9) | 0.0 (0) | 3.0 (2) | 4.5 (11) |
| Acute pancreatitis | 0.6 (1) | 0.0 (0) | 0.0 (0) | 0.4 (1) |
| Urinary tract infection | 0.6 (1) | 0.0 (0) | 0.0 (0) | 0.4 (1) |
Postoperative complications were categorized into major (life-threatening, potential for permanent harm, abdominal reoperation required) and minor (outpatient percutaneous or endoscopic intervention, supplemental nutrition required, or any event requiring re-admission for inpatient management [without reoperation/intervention]) types. The percentage of total participants with one or more of these complications is shown.
Details for all re-admission events are provided in eTable3. Independent adjudication determined that 85% of re-admissions were related to the original WLS procedure. Fifteen percent of re-admissions were related to abdominal pain (unrelated to WLS), medication error, and elective orthopedic surgery (eTable3).
DISCUSSION
The safety of WLS is a major area of concern for families and healthcare providers alike, particularly as these procedures become more common. Teen-LABS is the first multicenter study to collect rigorously defined prospective preand postoperative data in adolescent WLS patients to assess the risks and benefits of these procedures. The ongoing study will permit characterization of longer term outcomes in this cohort.
These initial data allow detailed description of the health status of adolescents undergoing WLS at five academic medical centers and provide estimates of major and minor complications observed in the first 30 days after operation. The methodology used, including review by an external adjudication committee, results in a complete and objective assessment of the risks facing adolescents undergoing WLS.
These data demonstrate that 92% of the 242 severely obese adolescents who underwent WLS did so without major complications. This safety profile, including a 5% rate of major inpatient morbidity was demonstrated despite the presence of significant co-morbidities and severity of obesity that exceeds that of most published adult and adolescent bariatric studies 6,13,22. By comparison, this is consistent with complications in 409 adolescents undergoing RYGB in California14 where inpatient morbidity, reoperation, and re-admission rates of 5.9%, 2.9%, and 11.5% respectively were documented. Our data are also consistent with the inpatient morbidity rate of 5.5% for 309 adolescents undergoing predominantly RYGB11, and an analysis of 771 adolescent cases in the National Inpatient Sample dataset showing a 4.2% inpatient morbidity 8.
While these previous studies all have strengths, especially those derived from relatively large numbers, the administrative nature of much of the data has inherent limitations. In addition to replicating the 5% major inpatient morbidity rate, Teen-LABS also provides estimates of less serious complications stratified by perioperative time period, and objectively documents the relatedness of re-admissions to the WLS through review and adjudication by experts who do not participate in the study.
The types of complications observed in our adolescents are similar to that which would be expected for WLS in severely obese adults. Indeed, in a contemporaneous, prospective, randomized trial of RYGB and VSG in adults 23 reported 30-day complication rates for RYGB and VSG of 26.5% and 14.2%. Although Teen-LABS was not originally designed to compare risks of different WLS procedures, these adult trial data are in excellent agreement with our combined total major and minor complication estimates of 26.1% and 16.4% for RYGB and VSG in adolescents.
The second important contribution of Teen-LABS is the detailed baseline phenotyping of a large cohort of severely obese adolescents. Obesity in youth is associated with development of cardiovascular risk factors 5. Few prior studies have been able to shed light on the objective laboratory measures of cardiovascular risk and general health status of adolescents who are on average greater than two-fold heavier than ideal weight. Nationally representative data demonstrate prevalence rates of hypertension, high LDL-C, low HDL-C of 3%, 8%, and 3%, respectively in adolescents 24. In comparison, our data suggest that in the setting of severe obesity in a select, referral population, these conditions may be expected in as many as 45%, 8.5%, and 64% of subjects, respectively. An unexpected but concerning finding of this study was the high prevalence of other factors that were not considered clinical selection criteria. For instance, we found evidence of systemic inflammation (elevated hs-CRP) in more than three quarters of our subjects, a finding thought to be a potential link between obesity, cardiovascular disease, and a pro-thrombotic state 25. In addition, 19% of participants demonstrated objective evidence of abnormal kidney function.
Although ascertainment of urine protein was not done with the first morning void, these data are concerning, especially in light of other data suggesting that obesity is an independent risk factor for kidney impairment 26, even in pediatric age groups 27. Further studies are needed to assess predictors of renal dysfunction in severely obese youth.
Strengths of Teen-LABS include multi-site enrollment of consecutive patients, standardized prospective data collection by trained research staff during current clinical practice in five centers using several bariatric surgical procedures, an infrastructure which facilitates ancillary investigation of questions about severe pediatric obesity and surgical intervention, and the ability to compare outcomes to a large adult cohort with the same study design. In addition, this study suggests hypotheses and provides preliminary data for future, focused projects. The sample size and observational design without standardization of surgical technique and clinical care restrict interpretation of infrequent complications, while its lack of ethnic diversity limits generalizability. However, the study does provide information about types of complications to be expected with frequency estimates for the procedures used.
Conclusion
We have prospectively and comprehensively characterized the baseline phenotype and described the safety of WLS procedures when performed in severely obese adolescents. The findings highlight the presence of both overt co-morbidities and less obvious indicators of organ dysfunction at baseline, and indicate that WLS procedure selection has evolved over time. The fact that major, life-threatening complications were infrequently observed documents the short-term safety of these procedures in this patient population. Clinical data and saved biospecimens from this cohort 28 will provide materials for more in-depth ancillary studies of obesity-related disease and response to surgical therapy in adolescents. Furthermore, the psychosocial health and behaviors of the adolescent patient are important considerations, and as such the Teen-LABS consortium is also addressing key psychosocial questions which will be published separately. These studies should help to inform patient evaluation and management. Longitudinal data from this cohort will inform us about the effects of surgery on co-morbidities, physical/metabolic health and health-related quality of life changes, nutritional effects, and durability of weight loss.
Supplementary Material
Acknowledgements
The Teen-LABS consortium was funded by cooperative agreements with the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), through grants: U01DK072493, UM1DK072493, and UM1DK095710 (University of Cincinnati). The study was also supported by grants UL1 TR000077-04 (Cincinnati Children's Hospital Medical Center), UL1RR025755 (Nationwide Children's Hospital), M01-RR00188 (Texas Children's Hospital/Baylor College of Medicine), UL1 RR024153 and UL1TR000005 (University of Pittsburgh), UL1 TR000165 (University of Alabama, Birmingham).
The authors would like to acknowledge the contributions of the other members of the Teen-LABS Consortium:
Cincinnati Children's Hospital Medical Center: Avani Modi, PhD, Victor Garcia, MD, Jennie Noll, PhD, Rosie Miller, RN, CCRC, Rachel Akers, MPH, April Carr, BS, Lindsey Shaw, MS, Cynthia Spikes, CRC, Shelley Kirk, PhD, RD, Linda Kollar, RN, Christine Wright, RN, Stephen Daniels, MD, PhD, Jennifer Andringa, BS, Laurie Bishop, MA, MS, Carolyn Powers, RD, Michelle Starkey Christian, Yanhong Liu, MS, Tawny W. Boyce, MS, MPH, Tara Schafer-Kalkhoff, MA, CCRP, Suzanne Summer, MS, RD; University of Cincinnati: Mark Simmons, MEng; Texas Children's Hospital, Baylor Medical Center: Vadim Sherman, MD, Margaret Callie Lee, MPH, David Allen, BS, Trisha Walters-Salas, BSN, Susanne Trout, RD, Gia Washington, PhD, Karin Price, PhD; Children's Hospital of Alabama University of Alabama: Ronald Clements, MD, Richard Stahl, MD, Molly Bray, PhD, Beverly Haynes, BSN, Heather Austin, PhD, Constance Cushing, DPT; University of Pittsburgh Medical Center: Ramesh Ramanathan, MD, Carol A. McCloskey, MD, George M. Eid, MD, Jessie Eagleton, MPH, William Gourash, MSN, CRNP, Lindsay Lee, MS, RD, Sheila Pierson, BS, Catherine Gibbs, MS, Dana Farrell, BS, Christopher Coburn, PhD, Dana Rofey, PhD, Rebecca Search, MPH, Mark Shaw, MS; Nationwide Children's Hospital Medical Center: Steven Teich, MD, Allen Browne, MD, Karen Carter, CCRC, Melinda Helton, RN, Bonny Bowen, RN, Cynthia Yensel, RN, MS, Patsy Guittar, MSN, Deanna Lear, RN,MS, Robert David Murray, MD, Ihouma Eneli, MD, Andrea Hedge, Kevin Smith, PhD, Amy Baughcum, PhD, Grace Wentzel, CCRP, Paula Davies, CCRC.
Dr. Todd Jenkins had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
The NIDDK project scientist was involved in the design and conduct of the study, interpretation of the data, review and approval of the manuscript, and decision to submit the manuscript for publication
The authors acknowledge the generous contribution of methodologic details from the LABS consortium. Finally, the consortium is grateful for the important work done by the adjudication committee.
Thomas H. Inge has received research grant funding from Ethicon Endosurgery
Marc P. Michalsky has received research grant funding from Allergan Medical Corporation and serves as a proctor and speaker for Covidien
Carroll M. Harmon has served on an Advisory Panel for Stryker Corporation.
Dr. Courcoulas has received research grants from Allergan, Pfizer, Covidien, EndoGastric Solutions, Nutrisystem and is on the Scientific Advisory Board of Ethicon J & J Healthcare System.
Sean J. Barnett has served as a consultant for Kaleidoscope Surgical Innovations Ltd., and Nucleus Medical
Contributor Information
T.H. Inge, Cincinnati Children's Hospital Medical Center, Cincinnati OH
M.H. Zeller, Cincinnati Children's Hospital Medical Center, Cincinnati OH
T.M. Jenkins, Cincinnati Children's Hospital Medical Center, Cincinnati OH
M. Helmrath, Cincinnati Children's Hospital Medical Center, Cincinnati OH
M.L. Brandt, Texas Children's Hospital, Baylor College of Medicine, Houston TX
M.P. Michalsky, Nationwide Children's Hospital, Columbus OH
C.M. Harmon, University of Alabama at Birmingham, Birmingham AL
A. Courcoulas, University of Pittsburgh Medical Center, Pittsburgh PA
M. Horlick, National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda MD
S.A. Xanthakos, Cincinnati Children's Hospital Medical Center, Cincinnati OH
L. Dolan, Cincinnati Children's Hospital Medical Center, Cincinnati OH
M. Mitsnefes, Cincinnati Children's Hospital Medical Center, Cincinnati OH
S.J. Barnett, Cincinnati Children's Hospital Medical Center, Cincinnati OH
C.R. Buncher, University of Cincinnati, Cincinnati OH
REFERENCES
- 1.Skelton JA, Cook SR, Auinger P, Klein JD, Barlow SE. Prevalence and trends of severe obesity among US children and adolescents. Acad Pediatr. 2009 Sep-Oct;9(5):322–329. doi: 10.1016/j.acap.2009.04.005. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Koebnick C, Smith N, Coleman KJ, et al. Prevalence of extreme obesity in a multiethnic cohort of children and adolescents. The Journal of pediatrics. 2010 Jul;157(1):26–31. e22. doi: 10.1016/j.jpeds.2010.01.025. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3.Treadwell JR, Sun F, Schoelles K. Systematic review and meta-analysis of bariatric surgery for pediatric obesity. Ann Surg. 2008 Nov;248(5):763–776. doi: 10.1097/SLA.0b013e31818702f4. [DOI] [PubMed] [Google Scholar]
- 4.Kimm SY, Barton BA, Obarzanek E, et al. Obesity development during adolescence in a biracial cohort: the NHLBI Growth and Health Study. Pediatrics. 2002 Nov;110(5):e54. doi: 10.1542/peds.110.5.e54. [DOI] [PubMed] [Google Scholar]
- 5.Freedman DS, Mei Z, Srinivasan SR, Berenson GS, Dietz WH. Cardiovascular risk factors and excess adiposity among overweight children and adolescents: the Bogalusa Heart Study. The Journal of pediatrics. 2007 Jan;150(1):12–17. e12. doi: 10.1016/j.jpeds.2006.08.042. [DOI] [PubMed] [Google Scholar]
- 6.O'Brien PE, Sawyer SM, Laurie C, et al. Laparoscopic adjustable gastric banding in severely obese adolescents: a randomized trial. Jama. Feb 10;303(6):519–526. doi: 10.1001/jama.2010.81. [DOI] [PubMed] [Google Scholar]
- 7.Treadwell JR, Sun F, Bruening W, et al. Bariatric Surgery in Pediatric Patients. ECRI Institute; 2007. [Google Scholar]
- 8.Tsai WS, Inge TH, Burd RS. Bariatric surgery in adolescents: recent national trends in use and in-hospital outcome. Arch Pediatr Adolesc Med. 2007 Mar;161(3):217–221. doi: 10.1001/archpedi.161.3.217. [DOI] [PubMed] [Google Scholar]
- 9.Kelleher DC, Merrill CT, Cottrell LT, Nadler EP, Burd RS. Recent National Trends in the Use of Adolescent Inpatient Bariatric Surgery: 2000 Through 2009. Arch Pediatr Adolesc Med. Dec 17;2012:1–7. doi: 10.1001/2013.jamapediatrics.286. [DOI] [PubMed] [Google Scholar]
- 10.Schilling PL, Davis MM, Albanese CT, Dutta S, Morton J. National trends in adolescent bariatric surgical procedures and implications for surgical centers of excellence. J Am Coll Surg. 2008 Jan;206(1):1–12. doi: 10.1016/j.jamcollsurg.2007.07.028. [DOI] [PubMed] [Google Scholar]
- 11.Varela JE, Hinojosa MW, Nguyen NT. Perioperative outcomes of bariatric surgery in adolescents compared with adults at academic medical centers. Surg Obes Relat Dis. 2007 Sep-Oct;3(5):537–540. doi: 10.1016/j.soard.2007.07.002. discussion 541-532. [DOI] [PubMed] [Google Scholar]
- 12.Nguyen NT, Karipineni F, Masoomi H, et al. Increasing utilization of laparoscopic gastric banding in the adolescent: data from academic medical centers, 2002-2009. Am Surg. 2011 Nov;77(11):1510–1514. [PubMed] [Google Scholar]
- 13.Olbers T, Gronowitz E, Werling M, et al. Two-year outcome of laparoscopic Roux-en-Y gastric bypass in adolescents with severe obesity: results from a Swedish Nationwide Study (AMOS). Int J Obes (Lond) 2012 Nov;36(11):1388–1395. doi: 10.1038/ijo.2012.160. [DOI] [PubMed] [Google Scholar]
- 14.Jen HC, Rickard DG, Shew SB, et al. Trends and outcomes of adolescent bariatric surgery in California, 2005-2007. Pediatrics. 2010;126(4):e746–753. doi: 10.1542/peds.2010-0412. 2010. [DOI] [PubMed] [Google Scholar]
- 15.Sugerman HJ, Sugerman EL, DeMaria EJ, et al. Bariatric surgery for severely obese adolescents. J Gastrointest Surg. 2003 Jan;7(1):102–107. doi: 10.1016/S1091-255X(02)00125-7. discussion 107-108. [DOI] [PubMed] [Google Scholar]
- 16.Zitsman JL, Fennoy I, Witt MA, Schauben J, Devlin M, Bessler M. Laparoscopic adjustable gastric banding in adolescents: short-term results. J Pediatr Surg. 2011 Jan;46(1):157–162. doi: 10.1016/j.jpedsurg.2010.09.082. [DOI] [PubMed] [Google Scholar]
- 17.Inge TH, Zeller M, Harmon C, et al. Teen-Longitudinal Assessment of Bariatric Surgery: methodological features of the first prospective multicenter study of adolescent bariatric surgery. J Pediatr Surg. 2007 Nov;42(11):1969–1971. doi: 10.1016/j.jpedsurg.2007.08.010. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 18.Pratt JS, Lenders CM, Dionne EA, et al. Best practice updates for pediatric/adolescent weight loss surgery. Obesity (Silver Spring) 2009 May;17(5):901–910. doi: 10.1038/oby.2008.577. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 19.Belle SH, Berk PD, Courcoulas AP, et al. Safety and efficacy of bariatric surgery: Longitudinal Assessment of Bariatric Surgery. Surg Obes Relat Dis. 2007 Mar-Apr;3(2):116–126. doi: 10.1016/j.soard.2007.01.006. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 20.Mackey RH, Belle SH, Courcoulas AP, et al. Distribution of 10-year and lifetime predicted risk for cardiovascular disease prior to surgery in the longitudinal assessment of bariatric surgery-2 study. The American journal of cardiology. 2012 Oct 15;110(8):1130–1137. doi: 10.1016/j.amjcard.2012.05.054. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21.Levey AS, Eckardt KU, Tsukamoto Y, et al. Definition and classification of chronic kidney disease: a position statement from Kidney Disease: Improving Global Outcomes (KDIGO). Kidney Int. 2005 Jun;67(6):2089–2100. doi: 10.1111/j.1523-1755.2005.00365.x. [DOI] [PubMed] [Google Scholar]
- 22.Flum DR, Belle SH, King WC, et al. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009 Jul 30;361(5):445–454. doi: 10.1056/NEJMoa0901836. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 23.Helmio M, Victorzon M, Ovaska J, et al. SLEEVEPASS: a randomized prospective multicenter study comparing laparoscopic sleeve gastrectomy and gastric bypass in the treatment of morbid obesity: preliminary results. Surg Endosc. 2012 Sep;26(9):2521–2526. doi: 10.1007/s00464-012-2225-4. [DOI] [PubMed] [Google Scholar]
- 24.May AL, Kuklina EV, Yoon PW. Prevalence of cardiovascular disease risk factors among US adolescents, 1999-2008. Pediatrics. 2012 Jun;129(6):1035–1041. doi: 10.1542/peds.2011-1082. [DOI] [PubMed] [Google Scholar]
- 25.Katsuren K, Nakamura K, Ohta T. Effect of body mass index-z score on adverse levels of cardiovascular disease risk factors. Pediatr Int. 2012 Apr;54(2):200–204. doi: 10.1111/j.1442-200X.2011.03499.x. [DOI] [PubMed] [Google Scholar]
- 26.Hunley TE, Ma LJ, Kon V. Scope and mechanisms of obesity-related renal disease. Curr Opin Nephrol Hypertens. 2010 May;19(3):227–234. doi: 10.1097/MNH.0b013e3283374c09. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 27.Codoner-Franch P, Ballester-Asensio E, Martinez-Pons L, Vallecillo-Hernandez J, Navarro-Ruiz A, del Valle-Perez R. Cystatin C, cardiometabolic risk, and body composition in severely obese children. Pediatr Nephrol. 2011 Feb;26(2):301–307. doi: 10.1007/s00467-010-1679-7. [DOI] [PubMed] [Google Scholar]
- 28.Inge T. http://www.cincinnatichildrens.org/research/divisions/t/teen-labs/default/default/
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