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

Not Applicable

Completed

• Conditions: Morbid Obesity

• Registration Number: NCT01703546
• Lead Sponsor: Northwell Health

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2012-08-10
• Study First Submitted QC: 2012-10-08
• Study First Posted: 2012-10-10
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-12
• Last Update Posted: 2016-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 420

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
% Excess Body Weight Loss (%EWL)	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

Name	Time	Method
HgbA1c	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.

Trial Locations

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