Weight Loss & Comorbidity Resolution With LAGB Alone vs. LAGB With Gastric Plication

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Alan Geiss, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01703546
First received: August 10, 2012
Last updated: October 8, 2012
Last verified: October 2012
  Purpose

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 Intervention
Morbid Obesity
Procedure: LAGB & LGCP

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:
  • % Excess Body Weight Loss (%EWL) [ Time Frame: 6 months post procedure ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months post procedure ] [ Designated as safety issue: No ]
    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.


Enrollment: 92
Study Start Date: November 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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, Cancer, Liver failure or Kidney failure
  • Previous malabsorptive or restrictive procedures performed for the treatment of obesity
  • Scheduled concurrent surgical procedure, with the exception of liver biopsy
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703546

Locations
United States, New York
Syosset Hospital, Center for Bariatric Surgical Specialties
Syosset, New York, United States, 11791
Syosset Hospital - Center for Bariatric Surgical Specialties, 221 Jericho Turnpike
Syosset, New York, United States, 11791
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Investigators
Principal Investigator: Alan C Geiss, MD North Shore LIJ Health System, Syosset Hospital, Center for Bariatric Surgical Specialties
Study Chair: Robert Ward, MD North Shore LIJ Health System, Syosset Hospital, Director of Surgery
  More Information

No publications provided

Responsible Party: Alan Geiss, Director of Bariatric & Advanced Laparoscopic Surgery, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01703546     History of Changes
Other Study ID Numbers: 11-277A
Study First Received: August 10, 2012
Last Updated: October 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:
Morbid Obesity
Weight Loss Surgery
Laparoscopic Adjustable Gastric Band
Laparoscopic Gastric Plication
Imbrication

Additional relevant MeSH terms:
Obesity
Weight Loss
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on September 18, 2014