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

Northwell Health420 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

420

Conditions

Morbid Obesity

Interventions

LAGB & LGCPPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Syosset Hospital - Center for Bariatric Surgical Specialties, 221 Jericho Turnpike

Syosset, New York, United States

Syosset Hospital, Center for Bariatric Surgical Specialties

Syosset, New York, United States

Outcomes

Primary Outcomes

% 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.

Time frame: 6 months post procedure

Secondary Outcomes

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.

Time frame: 12 months post procedure

Data from ClinicalTrials.gov

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