Laparoscopic Adjustable Gastric Banding for the treatment of adolescent morbid obesity.

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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 A 2. 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
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The laparoscopic adjustable gastric banding
World literature review-Adult
LAGB Gastric 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 2004135326-351
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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
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LapBand by Bioenterics
Lap Band 10 cm Lap Band VG
Port
Balloon
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Normal barium swallow
Normal radiograph
Proximal Gastric pouch
Band at 45o
LapBand at 45o
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Pre FDA RESULTS on off label patients
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Conflicted Adolescents

• Want to lose weight and look like their peers
• Want to eat like their peers

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Pouch enlargement
Band at 45o
Band at 0o
Band
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Adult protocol
Modified Adolescent protocol
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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 (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 cm VG Diet Same
Adjustment same Readjustment criteria
Same Follow up 1. RTC 1wk., 6 wks, then
monthly. 2. FDA study visits q 3 m x 1 yr,
q 6m x 4yr 3. Close phone and Email contact
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THE TEAM CONCEPT
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• 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

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Team Clinical Evaluation

• Psychologist
• Adolescent Pediatrician
• Nutritionist
• Physical Therapist
• PNP (Nurse Coordinator)
• Pediatric Surgeon

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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 months 6 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)
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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.
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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
• I would insist on a BAND

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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) Psyc
hologist 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)
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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.

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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
• Tanner Stage IV
• 5 years hx of obesity
• 6 months of supervised weight loss

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PREOP SURGICAL EVALUATION
FOLLOW UP
Labs Metabolic syndrome Insulin resistance
Non alcoholic fatty liver disease Baseline
nutritional indices Coags Hematology Testing Bar
ium 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