Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate whether combining laparoscopic adjustable gastric band (AKA: lap-band surgery, LAGB) and laparoscopic gastric plication (making tucks in the large curve of the stomach with stitches) to lap-band surgery alone will result in a greater loss of excess weight over time. We anticipate that the average percent of excess body weight loss for study subjects will exceed 29% at 12 months.

Detailed Description
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Laparoscopic Adjustable Gastric Banding when combined with gastric plication will provide lasting weight loss benefits to patients. We are projecting that the percent of Excess Body Weight Loss (% EWL) will be greater in study subjects when compared with our control group with LAGB alone. Furthermore, it is anticipated that the % EWL in study subjects will be similar to patients who have laparoscopic Roux-En-Y Gastric Bypass.

Official Title
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Weight Loss & CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: LAGB & LGCP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body Mass Index (BMI) > 35 Meet ASMBS and NIH criteria for Weight Loss Surgery ASA Class I - III Agree to refrain from any type of weight-loss drug (prescription or OTC)or elective procedure that would affect body weight for the duration of the trial. English speaking & comprehension Normal mental caliber. Exclusion Criteria: Pregnancy, Liver failure or Kidney failure Women of childbearing potential lactating at the time of initial consult or at the time of surgery Any condition which precludes compliance with the study History or presence of pre-existing autoimmune connective tissue disease or cancer must be evaluated on a case by case basis by the Director of Bariatric Surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LAGB & LGCP<br>All study patients will have the following surgical procedure: Laparoscopic Adjustable Gastric Banding and Gastric Plication (LAGB & LGCP). The percent of Excess Body Weight Loss will be monitored at all post op visits. | Procedure: LAGB & LGCP<br>* All study patients will have the following surgical procedures: Laparoscopic Adjustable Gastric Band & Laparoscopic Gastric Plication. % Excess Body Weight Loss will be monitored at each post op visit.<br>* Other names: Laparoscopic Adjustable Gastric Band & Gastric Plication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % Excess Body Weight Loss (%EWL) | Excess Body Weight is identified pre-operatively and will be monitored during each post operative visit. The percent of Excess Body Weight Loss (%EWL) will be calculated using as a baseline the % Excess Body Weight identified pre-operatively during the subject's initial consult. The change in %EWL at will be calculated at 6 months and 12 months. The %EWL will then be compared to a similar cohort of patients who had the LAGB alone at the same milestones. It is anticipated that study patients' %EWL will be significantly greater. | 6 months post procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HgbA1c | A baseline HgbA1c will be obtained pre-operatively for study patients with a comorbid diagnosis of Type 2 Diabetes. HgbA1C will also be obtained at 6 months and 12 months to evaluate the change from the baseline HgbA1C. | 12 months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid Obesity, Weight Loss Surgery, Laparoscopic Adjustable Gastric Band, Laparoscopic Gastric Plication, Imbrication