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

Northwell Health

Status: Completed

Conditions: Morbid Obesity

Treatments: Procedure: LAGB & LGCP

Study type: Interventional

Funder types: Other

Identifiers

NCT01703546

11-277A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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420 participants in 1 patient group

LAGB & LGCP

Experimental group

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.

Treatment:

Procedure: LAGB & LGCP