Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding

Morbid obesity is a major problem affecting the lives of millions in the US. As of 2008,
overall prevalence of obesity as defined by body mass index (BMI) greater than 30 kg/m2 was
33.8%.1 Obesity adversely affects the lives of millions of Americans by increasing the risk
for co-morbid conditions such as diabetes mellitus, obstructive sleep apnea, hypertension,
and even certain cancers.2-4 The laparoscopic adjustable gastric banding (LAGB) procedure is
a safe, effective, and durable treatment option for refractory morbid obesity and its
related health consequences.5 This minimally invasive technique is now a popular approach
for bariatric surgery, and it offers obvious advantages such as decreased operating time,
shorter hospital stay (often same day surgery), and favorable complication rates as compared
with other bariatric procedures.4,5

One of the biggest drawbacks to LAGB [when compared to the 'gold standard' of bariatric
surgery: Roux-en-Y gastric bypass] is that patients tend to have a slower, less dramatic
weight loss in the first few months after surgery.5-7 In addition, the LAGB procedure is
associated with an approximate 3% chance of "band slippage" complications.8 In order to
address some of these issues modifications in the technique of LAGB surgery have been made.
Techniques such as a "pars-flaccida approach" to tissue dissection and the placement of
plication sutures to "anchor" the redundant stomach around the newly placed band device were
introduced and shown to have positive results in reducing band complication rates.8 More
recently, sleeve gastrostomy procedures (the greater curvature and significant portion of
the body of the stomach is resected over a sizing bougie; leaving a narrow 'sleeve' of
stomach) have also become popular in treating patients with morbid obesity.9 Combining these
concepts, a modified technique of plicated LAGB was introduced.

At the time of LAGB placement, plication sutures can be placed along the body & greater
curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like
orientation. It was recently reported that this modified technique of plicated LAGB could
result in lower band slippage complication rates and faster, early weight loss.8

However, as of today there exists no prospective, randomized study that compares the
outcomes of this modified surgical technique to the standard procedure (SLAGB).

This is a prospective randomized clinical trial comparing PLAGB versus SLAGB. All adult (age
older than 18 years) morbidly obese patients meeting NIH criteria for bariatric surgery (BMI
> 35 + co-morbid disease or BMI > 40) who are undergoing bariatric surgery at the Duke
Metabolic and Weight Loss Surgery Center and the University of Pittsburgh Medical Center
will be recruited. All enrolled patients will be randomly assigned to either the SLAGB
(control) group or the PLAGB (study) group. Variables to be studied include patient age,
gender, ethnicity, co-morbid disease conditions, height, weight, BMI, intra-operative data
such as operative time and blood loss, and post-operative outcomes including length of
hospital stay, complication rates, weight loss, and co-morbid disease resolution. In
addition, each patient will complete standardized surveys rating their satisfaction from
surgery, their quality of life (OWL-QOL-17), and their sleepiness (Epworth Sleepiness Scale)
at three distinct time intervals: pre-operatively and at weeks 24 & 48.

Each subject will be followed and data collected according to the following schedule of
visits:

Study Visit Schedule:

Year 1:

Visit 1: Screening Visit Visit 2: Day 0 (surgery) Visit 3: Week 2 (+/- 2 days) Visit 4: Week
4 (1 month) Visit 5: Week 8 (2 months) Visit 6: Week 12 (3 months) Visit 7: Week 16 (4
months) Visit 8: Week 20 (5 months) Visit 9: Week 24 (6 months) Visit 10: Week 30 Visit 11:
Week 36 Visit 12: Week 42 Visit 13: Week 48

Year 2:

Visit 14: Week 60 Visit 15: Week 72 Visit 16: Week 84 Visit 17: Week 96

Year 3:

Visit 18: Week 128 (2.5 yrs) Visit 19: Week 156 (3 yrs)

Data gathered from PLAGB subjects will be compared to SLAGB controls. Pre- and
post-operative care will be delivered consistent with our established protocols and standard
practices; without regard to surgical approach. This includes a standard preoperative
evaluation and patient education period followed by surgery. After surgery, patients are
usually discharged from the hospital within the first 24 hours. Follow-up of patients will
include an initial post-discharge clinic visit within the first 2 weeks, and subsequent
visits scheduled at the time intervals as listed above. Subjects will be followed for a
period of approximately 12 months.

This study compares a modified bariatric surgical approach. PLAGB will be studied and
compared to the SLAGB procedure through a prospective randomized clinical trial.

Inclusion Criteria: Subjects must meet the following criteria to be eligible for study
entry:

1. Age between 18-60 years,

2. Morbidly obese:

a. BMI > 40, or b. BMI > 35 + co-morbid obesity related disease condition c)BMI < or equal
to 55

Exclusion Criteria: Subjects meeting the following criteria will be excluded from study
entry:

1. Patients with any major medical problems contraindicating surgery (eg.myocardial
infarct within last 6 months, cancer within last 5 years, end stage renal/liver
disease, etc.)

2. Patients with a medically treatable cause of obesity (eg. untreated hypothyroidism,
Prader-Willi, etc.)

3. Patients who elect to undergo a surgery other than a PLAGB or SLAGB

4. Patient who is unwilling to be randomized to PLAGB or SLAGB

5. Pregnant or planning pregnancy within 12 months

6. Alcohol or drug addiction

7. Established infection anywhere in the body at the time of surgery

8. Previous history of bariatric surgery, gastric surgery, intestinal obstruction, or
adhesive peritonitis.

9. Family or patient history of autoimmune disease

10. Hiatal Hernia > 3cm (as reported per radiology on pre-operative swallow study)