Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication
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ClinicalTrials.gov Identifier: NCT01703546 |
Recruitment Status
:
Completed
First Posted
: October 10, 2012
Last Update Posted
: January 14, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Morbid Obesity | Procedure: LAGB & LGCP | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 420 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Weight Loss & CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication |
Study Start Date : | November 2011 |
Actual Primary Completion Date : | November 2015 |
Actual Study Completion Date : | November 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: LAGB & LGCP
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
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.
Other Name: Laparoscopic Adjustable Gastric Band & Gastric Plication
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- % Excess Body Weight Loss (%EWL) [ Time Frame: 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.
- HgbA1c [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01703546
United States, New York | |
Syosset Hospital - Center for Bariatric Surgical Specialties, 221 Jericho Turnpike | |
Syosset, New York, United States, 11791 | |
Syosset Hospital, Center for Bariatric Surgical Specialties | |
Syosset, New York, United States, 11791 |
Study Chair: | Robert Ward, MD | North Shore LIJ Health System, Syosset Hospital, Director of Surgery | |
Principal Investigator: | Allison Barrett, MD | North Shore LIJ Health System Syosset Hospital |
Responsible Party: | Allison Barrett, Principal Investigator, North Shore Long Island Jewish Health System |
ClinicalTrials.gov Identifier: | NCT01703546 History of Changes |
Other Study ID Numbers: |
11-277A |
First Posted: | October 10, 2012 Key Record Dates |
Last Update Posted: | January 14, 2016 |
Last Verified: | January 2016 |
Keywords provided by Allison Barrett, North Shore Long Island Jewish Health System:
Morbid Obesity Weight Loss Surgery Laparoscopic Adjustable Gastric Band Laparoscopic Gastric Plication Imbrication |
Additional relevant MeSH terms:
Weight Loss Obesity, Morbid Body Weight Changes Body Weight Signs and Symptoms |
Obesity Overnutrition Nutrition Disorders Overweight |