Morbid Obesity
Conditions
Keywords
Morbid Obesity, Weight Loss Surgery, Laparoscopic Adjustable Gastric Band, Laparoscopic Gastric Plication, Imbrication
Brief summary
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
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.
Interventions
PROCEDURELAGB & LGCP
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.
Sponsors
Northwell Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Excess Body Weight Loss (%EWL) | 6 months post procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HgbA1c | 12 months post procedure | 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. |
Countries
United States
Outcome results
None listed