# Presentation: 675305

## 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 Surgery****1**** and Pediatric Surgery ****2****, and the New Hope Pediatric & Adolescent Weight Management Project at the University of Illinois at Chicago**

## The laparoscopic adjustable gastric banding

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- Proximal
- Gastric
- Pouch

- _LAGB_	   _Gastric bypass_

- % 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*

- World literature review-Adult

## The FDA trial for “LAGB® Laproscopic adjustable gastric banding as a treatment for morbid obesity in adolescents”  at UIC

- • 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

**The FDA trial for **_***“LAGB® Laproscopic adjustable gastric banding as a treatment for morbid obesity in adolescents***_***”*****  ****at UIC**

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## LapBand® by Bioenterics

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- Port

- Lap Band 10 cm      Lap Band VG

- Balloon

## LapBand®

**LapBand®**
**at 45****o**

- Proximal
- Gastric
- pouch

**Normal barium swallow**

**Normal radiograph**

- Band
- at 45o

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## Pre FDA RESULTS on “off label” patients 

|  Patient characteristics | Adolescent
n = 10 |   | Adult
n = 506 |   | p value |
| --- | --- | --- | --- | --- | --- |
| Age (years) | 18 (16-20) |   | 41 (21-65) |   |   |
| Preoperative BMI (kg/m2) | 49±8 |   | 478 |   | 0.6 |
| Operative time (min) | 55±22 |   | 6626 |   | 0.8 |
| Length of stay (hs) | 12±6 |   | 2225 |   | 0.8 |
| Follow up | BMI postop | % EWL | BMI postop | % EWL | %EWL |
|   3 months | 42±9 | 27±19 | 427 | 1811 | 0.7 |
|   6 months | 36±11 | 51±32 | 398 | 3116 | 0.5 |
|   12 months | 37±10 | 50±26 | 378 | 4023 | 0.8 |
|   18 months | 34±7 | 57±23 | 376 | 3919 | 0.6 |
| Complications

●Pouch enlargement (PE) | 

3 (30%) |   | 

58 (11%) |   | 

0.1 |
|  Reoperations for PE | 2 (20%)* at 10 and 16 months post LAGB |  | 9 (2%)* |  | 0.004* |

**Pre FDA RESULTS on “off label” patients **

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## 6

## “Conflicted” Adolescents

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

## Pouch enlargement

**Pouch enlargement**

- Band at 45o

- Band at 0o

- Band < 45o

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## Adult protocol

- Modified Adolescent protocol

_**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 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

- 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

**THE TEAM  CONCEPT**

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## Team Clinical Evaluation

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

## FDA trial

- 8 patients
- Ages 	15-17 yr
- 	Ave.      SD
-                16       +/- .91
- BMI  	36-75
- 	Ave.       SD
-               49.5       +/- 13.1

- RESULTS

- 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)

- 	_3 months_		_6 months_
-     Range	         Ave+/-SD	      Range	Ave+/-SD

- _Comorbidities _
- 50 % Sleep apnea
- 50 % hypertension
- 25 % hyperlipidemia
- 44 % Insulin resistance
- 70 % Fatty liver disease
- 37.5 % Dysmenorrhea
- 25 % Depression

- Length of surgery	 (Ave. 56 minutes)
- Length of stay (per protocol) (23 hrs)

## SUMMARY

- Is associated with short operative time, brief hospital stay and no mortality.
- Is effective and safe

**SUMMARY**

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- 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.

**CONCLUSION**

## 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)

##  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.

- 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.

- EXCLUSION CRITERIA FDA Study

## LAGB® Laparoscopic Adjustable Gastric Banding As A Treatment for Morbid Obesity in Adolescents 

- 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

**LAGB® Laparoscopic Adjustable Gastric Banding As A Treatment for Morbid Obesity in Adolescents**** **
**FDA Protocol**

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## PREOP SURGICAL EVALUATION

- 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

- FOLLOW UP

- Labs followed q 3 months for 1st year
- Then q year & prn.

- Manometry, Ba Swallow, Liver U/S repeated yearly & prn