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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
Sponsor:
Information provided by (Responsible Party):
Allison Barrett, North Shore Long Island Jewish Health System

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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: LAGB & LGCP Not Applicable

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.

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

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U.S. FDA Resources

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



Primary Outcome Measures :
  1. % 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.


Secondary Outcome Measures :
  1. 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
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.

Information from the National Library of Medicine

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


Locations
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
Sponsors and Collaborators
Northwell Health
Investigators
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