CLINICAL INVESTIGATION OF THE LAP-BAND MEDICAL

DEVICETopic by: Jayann Brown

Affiliation: Clinical Research ProgramHumber college Institute of Technology and

Advanced LearningMarch 2014

Preface

Title: Laparoscopic Gastric Bypass vs. LAP BAND for treatment of morbid obesity

Clinical Trials.gov identifier: NCT00247377

Trial was completed (App. 6 yrs) Principal Investigator: Ninh T Nguyen MD Sponsor Organization: University of

California Clinical trial was conducted at University

of California Irvine Medical Center

Hypothesis LAP-BAND can be performed safely and is associated

with reduced postoperative pain, decrease in morbidity, decreased ICU and hospital stay, reduced costs, comparable improvement in quality-of-life, and acceptable long-term weight loss compared with laparoscopic GBP

LAP-BAND is associated with a decrease in fluid requirement in the peri-operative period, improved postoperative pulmonary function, and lower intra-abdominal pressure compared to laparoscopic GBP

LAP-BAND does not alter esophageal motility and is effective in improvement of gastro-esophageal reflux disease (GERD) symptoms.

Introduction

Severe obesity or morbid obesity (being 100lbs above ideal body weight) is a growing problem in the U.S.

Individuals engaged in exercise ,dietary restriction, behaviour modification, pharmacological intervention regained weight in 2-4 yrs

Surgery is the only effective sustained weight loss treatment ( NIH conference 1991)

Introduction

Roux-en-Y gastric Bypass (GBP) is the golden standard bariatric surgical operation

Mean weight loss following GBP = App. 65% of the excess body weight during the first 12 - 18 mths

Long-term weight loss= App. 55-70% of excess body weight

Open & Laparoscopic GBP is associated with significant mortality and morbidity, anastomotic leak, pulmonary embolism, bowel obstruction, and postoperative stricture.

Introduction

In 2001 FDA approved the Laparoscopic Adjustable banding system (LAP-BAND) for weight reduction in morbid obese individuals

No cutting or opening of the stomach wall

Purpose of the study: to evaluate if the LAP-BAND procedure is as effective as the laparoscopic GBP procedure for treatment of morbid obesity.

THE DEVICE

The LAP-BAND® consists of a silicone gastric band which encircles the stoma.

The inner surface of the silicone band is inflatable and is connected by the tubing to the access port.

Class III medical device Premarket approval #:

P000008/S017

Product Procedures

5 holes drilled in stomach , camera guides the placement of the band around the upper part of the stomach.

The band creates a small stomach pouch that can hold only a small amount of food.

The surgeon adjusts the band by (adding or removing fluid, usually saline) by using a needle to pierce the access port, which is placed just beneath the skin.

Comparative procedures

ROUX- EN- Y LAP-BAND

Study objectives

To determine the short-term outcome, quality-of-life, costs, and long-term weight loss after laparoscopic GBP compared with LAP-BAND.

To compare physiologic changes such as peri-operative fluid requirement, postoperative pulmonary function, and intra-abdominal pressure after laparoscopic GBP and LAP-BAND.

To evaluate the effect of LAP-BAND on esophageal motility and its effectiveness in controlling gastro-esophageal reflux symptoms (GERD) for morbidly obese patients.

Number of research subjects

There will be two arms each projected to have 100 subjects for clinical significance of 0.05%. Arm1. Active comparator- LAP BAND Arm2. Active comparator –Laparoscopic GBP

Dropout rate is expected to be app. 20% (N= n/1-d)

The total number of subjects estimated to be enrolled in the program is 250.

Study Design

Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Open LabelPrimary Purpose: Treatment

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Subject selection- general characteristics

Body mass index (BMI) 40 kg/m2 or BMI 35 kg/m2 with significant obesity-related co-morbidities ( Normal BMI = 20-25kg/m2)

Acceptable operative risk Documented failure of nonsurgical weight-loss

programs Psychologically stable with realistic expectations Well-informed and motivated patient Supportive family/social environment Absence of uncontrolled psychotic or depressive

disorder No active alcohol or substance abuse

Inclusion criteria

Male or female patients with a BMI of 40-60 kg/m2 or 35kg/m2 with co-morbidities

Good health status with acceptable operative risk ( good cardiopulmonary function)

A willingness to follow protocol requirements: i.e signing informed consent forms, follow –up and completing protocol diagnostic tests.

Exclusion criteria

Prior upper abdominal surgery except cholecystectomy

Large abdominal ventral hernia Hiatal hernia Inadequate prior medical management Lack of patient motivation and contribution to long

term success (Patient must be willing to make major changes in their eating habits and lifestyle)

Unacceptable operative risk Minors are not psychologically fit to undergo such

surgery and pregnant women are excluded because of safety for the fetus

Study Procedures- Screening

The pre-operative screening will consist of: Physical exam Psychological exam, Complete blood tests, Imaging studies, Gastroscopy, Consultations with various specialists :

surgeon, endocrinologist, clinical nutritionist.

See Study Table

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Study Outcome PRIMARY OUTCOME MEASURE

Excess Weight Loss From Pre-operation to 5 Years Post-operation (weight loss as measured by change in percent of excess body weight) [Time Frame: Baseline to 5 years [ Designated as safety issue: No ]

SECONDARY OUTCOME MEASURES Changes in Quality of Life: Physical Functioning. Using SF-36

Questionnaire Pre-operation to 12 Months Post-operation (Response where 0 is non-functioning and 100 is fully functioning) [ Time Frame: Baseline to 12 months ]

[ Designated as safety issue: No ]

Cost of Procedure to the Medical Facility on Date of Procedure (operative and post-operative direct costs including hospital service costs per patient. costs reflect the average cost per patient in each of the two groups (band vs. bypass) at a single time point) [ Time Frame: date of surgery ] [ Designated as safety issue: No ]

Secondary outcomes cont’d

Changes in Quality of Life: Physical Role- Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation. ( 0 corresponds to no Physical Role and 100 corresponds to full Physical Role ) [ Time Frame: Baseline to 12 months ]

[ Designated as safety issue: No ]

Changes in Quality of Life: Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation. (0 corresponds to no bodily pain and 100 corresponds to complete bodily pain ) [ Time Frame: Baseline to 12 months ]

[ Designated as safety issue: No ]

Secondary outcomes cont’d

Changes in Quality of Life: General Health. Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation (0 corresponds to no general health satisfaction and 100 corresponds to complete health satisfaction ) [ Time Frame: Baseline to 12 months ]

[ Designated as safety issue: No ] Changes in Quality of Life: Vitality. Using SF-36 Questionnaire Pre-

operation to 12 Months Post-operation ( worst score being 0 and best score being 100 on a 1-100 point scale.) [ Time Frame: Baseline to 12 months ]

[ Designated as safety issue: No ]

Changes in Quality of Life: Social Functioning. Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation (Response where 0 corresponds to no social functioning and 100 corresponds to full social functioning ) [ Time Frame: Baseline to 12 months ]

[ Designated as safety issue: No ]

Secondary outcomes cont’d

Changes in Quality of Life : Emotional Role. Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation ( 0 corresponds to no emotional role and 100 corresponds to full emotional role) [ Time Frame: Baseline to 12 months ]

[ Designated as safety issue: No ] Changes in Quality of Life: Mental Health. Using SF-36

Questionnaire From Pre-operation to 12 Months Post-operation (0 corresponds to no mental health well-being and 100 corresponds to complete mental health well-being) [ Time Frame: Baseline to 12 months ]

[ Designated as safety issue: No ]

RISK ANAYSIS

Common side effects include nausea and vomiting, heartburn, abdominal pain, and slippage of the band

Serious Adverse Events include: erosion of the stomach, mortality (1/2000)

The most serious side effects require either another operation or hospitalization.

Surgery is reversible and LAP BAND can be removed

Follow up

Check-ups with the doctor is very important part of Lap Band follow-up.

If necessary adjustments are done. Depending on individual case checks will

be First month- Weekly or biweekly First year: 4-12 weeks Second and third year:3-6 mths Up to 5 yrs: annually

Safety

Will be determined by the severity and will be determined as : Mild - symptom barely noticeable to the patient; does not affect

performance or functioning. Prescription drugs not ordinarily needed for relief of symptom.

Moderate - symptom of sufficient severity to make patient uncomfortable; performance of daily activities affected; patient is unable to continue in study. Treatment of symptoms is needed.

Severe - symptom causes severe discomfort and may be such that patient cannot perform daily activities. Severity may result in cessation of treatment or require removal of the device, or treatment of symptom may be given and/or patient hospitalized.

Efficacy

Determined to be clinically effective if: 40% of the patients achieve weight loss of

30% of excess weight after 1yr Co-morbid conditions eg. type II diabetes,

hypertension measures are reduced Quality of life by the impact of weight loss is

improved based on SF-36

References P000008/S017: FDA Summary of Safety and Effectiveness .Retrieved

3/26/2014 from website http://www.accessdata.fda.gov/cdrh_docs/pdf/P000008S017b.pdf

Schematic of study Design . Retrieved3/22/ 2014 from website www.nidcr.nih.gov/NR/.../0/Schematic_of_Study_Design_Form.doc

Laparoscopic gastric banding Retrieved 3/22/2014 from website http://www.nlm.nih.gov/medlineplus/ency/article/007388.htm

 LAP-BAND® Adjustable Gastric Banding System - P000008/S017. Retrieved 3/22/2014 http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/recently-approveddevices/ucm248133.htm

Laparoscopic gastric bypass vs LAP-BAND for Treatment of Morbid Obesity. Retrieved from 3/7/2014 from http://clinicaltrials.gov/ct2/show/NCT00247377?term=laparoscopic+lapband&rank=1