Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2011 |
| End Date: | November 2015 |
Weight Loss & CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication
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.
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.
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.
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.
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.
We found this trial at
2
sites
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221 Jericho Turnpike
Syosset, New York 11791
Syosset, New York 11791
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