Back to resultsWeight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication
Primary Purpose
Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LAGB & LGCP
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity focused on measuring Morbid Obesity, Weight Loss Surgery, Laparoscopic Adjustable Gastric Band, Laparoscopic Gastric Plication, Imbrication
Eligibility Criteria
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.
Sites / Locations
- Syosset Hospital - Center for Bariatric Surgical Specialties, 221 Jericho Turnpike
- Syosset Hospital, Center for Bariatric Surgical Specialties
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
LAGB & LGCP
Arm Description
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.
Outcomes
Primary Outcome Measures
% 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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01703546
Brief Title
Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication
Official Title
Weight Loss & CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwell Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
Morbid Obesity, Weight Loss Surgery, Laparoscopic Adjustable Gastric Band, Laparoscopic Gastric Plication, Imbrication
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
420 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LAGB & LGCP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
LAGB & LGCP
Other Intervention Name(s)
Laparoscopic Adjustable Gastric Band & Gastric Plication
Intervention Description
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.
Primary Outcome Measure Information:
Title
% Excess Body Weight Loss (%EWL)
Description
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.
Time Frame
6 months post procedure
Secondary Outcome Measure Information:
Title
HgbA1c
Description
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.
Time Frame
12 months post procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Ward, MD
Organizational Affiliation
North Shore LIJ Health System, Syosset Hospital, Director of Surgery
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Allison Barrett, MD
Organizational Affiliation
North Shore LIJ Health System Syosset Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Syosset Hospital - Center for Bariatric Surgical Specialties, 221 Jericho Turnpike
City
Syosset
State/Province
New York
ZIP/Postal Code
11791
Country
United States
Facility Name
Syosset Hospital, Center for Bariatric Surgical Specialties
City
Syosset
State/Province
New York
ZIP/Postal Code
11791
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication
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