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Laparoscopic Adjustable Gastric Banding for the treatment of adolescent morbid obesity. The University of Illinois at Chicago experience.
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Laparoscopic Adjustable Gastric Banding for the treatment of adolescent morbid obesity. The University of Illinois at Chicago experience Holterman M 2,Browne A 2, Horgan S 1 Browne N 2 and Holterman A2. From the Department of Surgery, Divisions of Minimally Invasive Surgery1 and Pediatric Surgery 2, and the New Hope Pediatric & Adolescent Weight Management Project at the University of Illinois at Chicago
2 The laparoscopic adjustable gastric banding World literature review-Adult LAGBGastric bypass Proximal Gastric Pouch % EWL at 5 year 56% 58% Mortality 1/200 0 1/200 Complications 11% 25-40% Chapman et al. Laparoscopic adjustable gastric banding in the treatment of obesity: a systematic literature review. Surgery 2004;135:326-351
4 The FDA trial for “LAGB® Laproscopic adjustable gastric banding as a treatment for morbid obesity in adolescents”at UIC • 1999 The University of Illinois at Chicago (UIC) - FDA trial B • 2001 FDA approval for the LAP-BAND® device for laparoscopic adjustable gastric banding (LAGB) weight loss procedure in adults • 2004 (December) UIC receives FDA IDE for Lap-Band placement in 50 morbidly obese adolescents: A safety and efficacy trial
3 LapBand® by Bioenterics Lap Band 10 cm Lap Band VG Port Balloon
7 Normal radiograph Normal barium swallow Proximal Gastric pouch Band at 45o LapBand® at 45o
“Conflicted” Adolescents • Want to lose weight and look like their peers • Want to eat like their peers
8 Pouch enlargement Band at 45o Band at 0o Band < 45o
Adult protocol Modified Adolescent protocol 10 LAPBAND size: 10 or 11 cm Diet Week 1: Liquid Week 2-3: Blended diet Week 4-6: Soft Food. Week 7 and after: 3 small (<4oz) meals/day No liquid with meals Eat slowly and chew well Stop eating when full Adjustment (using barium swallow) First adjustment at 6 weeks Readjustment criteria 1) if no longer feels full with meals 2) if do not loose >5lbs/month or > 2lb/wk 3) increased hunger sensation Follow up: RTC suggested 6 times/year or if meet readjustment criteria LAPBAND size:11 cmVG Diet Same Adjustment same Readjustment criteria Same Follow up: 1. RTC1wk., 6 wks, then monthly. 2. FDA study visits: q 3 m x 1 yr, & q 6m x 4yr 3. Close phone and Email contact
THE TEAM CONCEPT 1 • COMPREHENSIVE AND INTEGRATED CARE • The surgeons, the pediatricians, the support team, the research team • The Adult Bariatric Surgery team- • SUPPORT for the Adolescent Bariatric team: • Advanced laparoscopic surgeon • Former PI in the FDA trial B; >700 cases of LAGB • EXPERIENCE in LAGB surgical and medical management • CONTINUITY OF CARE for the adolescent bariatric patients • The Adolescent Bariatric Surgery team. • The PRIMARY care surgeons for the patients • Department of Surgery, Division of Pediatric Surgery • Advanced laparoscopic surgeon • ASBS criteria
Team Clinical Evaluation • Psychologist • Adolescent Pediatrician • Nutritionist • Physical Therapist • PNP (Nurse Coordinator) • Pediatric Surgeon
FDA trial Comorbidities 50 % Sleep apnea 50 % hypertension 25 % hyperlipidemia 44 % Insulin resistance 70 % Fatty liver disease 37.5 % Dysmenorrhea 25 % Depression 8 patients Ages 15-17 yr Ave. SD 16 +/- .91 BMI 36-75 Ave. SD 49.5 +/- 13.1 RESULTS Length of surgery (Ave. 56 minutes) Length of stay (per protocol) (23 hrs) 3 months6 months Range Ave+/-SD Range Ave+/-SD Weight loss 30-48 lbs 35+/-8 56-120 lbs 83+/-20 % EWL 14-38% 28+/-10% 36-58% 44+/-12% Complications 0% 0% Readmission 1/8 ER visit for Barium swallow (negative)
11 SUMMARY • In this small early series of the FDA trial, LAGB as a treatment for MO in the adolescents: • Is associated with short operative time, brief hospital stay and no mortality. • Is effective and safe CONCLUSION The highest challenge of LAGB treatment for morbid obesity in the adolescents is the post-operative management. Close and long term follow-up, ensuring diet compliance and maintaining a high index of suspicion for early detection and treatment of pouch dilatation are essential.
If this was your child, what would you do? • 1/200 vs 1/2000 • Operate on 100,000 children: 500 vs 50 • 3 to 4 fold greater morbidity • Probably equal long term efficacy • Compliance problems either way • ??LAGB first and if not successful:->>> gastric bypass • 0.20 X 0.03 = 0.006 • 0.006 + 0.05 = 0.056 • 0.056%<0.5% (9-fold safer) • I would insist on a BAND
The Adolescent Bariatric Medical Team: Adolescent obesity specialist (adolescent pediatrician) Pediatric subspecialties (pulmonology, hepatology, etc) The Adolescent Bariatric Clinical Support Team: Nurse Coordinator (Pediatric Nurse Practitioner) Psychologist Nutritionist Exercise specialist (Physical therapist) The Adolescent Bariatric Program Support Team: Hospital Administrator Project Coordinator Medical insurance Coordinator Public relation Coordinator The Researchers School of Medicine (obesity-related liver disease, metabolic syndrome Inflammatory states, pulmonary disease) School of Nutrition (Body fat composition and fat metabolism School of Public Health ( Economics of obesity, Diet/nutrition and environmental factors)
EXCLUSION CRITERIA FDA Study • Intention or need to have another surgical procedure for weight reduction within 12 months of Lap Band placement. • History of congenital or acquired anomalies of the G.I. tract, such as; congenital or acquired intestinal telangiectasia, Crohn's disease or ulcerative colitis; severe cardiopulmonary disease or severe coagulapathy; hepatic insufficiency or cirrhosis. • Pregnancy or intention of becoming pregnant in the next 12 months. • Presence of psychiatric problems or immaturity which would compromise cooperation with the study protocol. • History of previous bariatric surgery, intestinal obstruction or adhesive peritonitis. • Presence of localized or systemic infection at the time of surgery. • Chronic use of aspirin and/or non-steroidal anti-inflammatory medications and unwillingness to discontinue the use of these concomitant medications. • History of gastric or esophageal surgery. • Use of weight loss medications. • History of esophageal dysmotility disorders. • Eating disorders.
1 LAGB® Laparoscopic Adjustable Gastric Banding As A Treatment for Morbid Obesity in Adolescents FDA Protocol • INCLUSION CRITERIA FDA Study • The 1991 NIH Consensus Development Conference on Gastrointestinal Surgery for Severe Obesity guidelines for bariatric surgery : • Severely obese patients with a BMI (body-mass index) > 40 Kg/m2 • or patients with a BMI > 35 Kg/m2 with coexisting morbidities. • Adolescents >14 y/o to < 18 y/o • Tanner Stage IV • > 5 years hx of obesity • > 6 months of supervised weight loss
PREOP SURGICAL EVALUATION FOLLOW UP Labs: Metabolic syndrome Insulin resistance Non alcoholic fatty liver disease Baseline nutritional indices Coags Hematology Testing: Barium Swallow Esophageal manometry Anesthesia evaluation DXA Liver & GB U/S Bone Age Sleep study if indicated by pulmonologist Labs followed q 3 months for 1st year Then q year & prn. Manometry, Ba Swallow, Liver U/S repeated yearly & prn