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

Completed · Not applicable

Conditions studied: Morbid Obesity

In brief

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.

Key facts

Study ID

NCT01703546

Run by

Northwell Health

People needed

420

Starts

2011-11-01

Expected to finish

2015-11-01

Last updated by the study team

2016-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.