Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding

The purpose of this study is to compare plicated laparoscopic adjustable gastric banding (PLAGB) to standard laparoscopic adjustable gastric banding (SLAGB) in a prospective randomized clinical trial. We hypothesize the plicated procedure will provide greater short- and long-term excess weight loss than the standard procedure. There exists little prospective randomized data regarding this topic and the recent position statement from the American Society for Metabolic and Bariatric Surgery (ASMBS) encourages this type of study. Further information on background and design of this study are provided in the detailed description.

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.

Please note: Per our FDA approved modification of 6/18/2014, all study specific testing was eliminated, and only safety assessments were completed in the surgical office at 6 months and 1 year after surgery.

Eligibility Criteria:
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)