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

Morbid Obesity Clinical Trial

Official title:

Weight Loss & CoMorbidity Resolution With Laparoscopic Adjustable Gastric Band Alone vs. Laparoscopic Adjustable Gastric Band With Gastric Plication

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703546
• Other study ID #: 11-277A
• Status: Completed
• Phase: N/A
• First received: August 10, 2012
• Last updated: January 12, 2016
• Start date: November 2011
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Weight Loss

Intervention

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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% 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.	6 months post procedure	No
Secondary	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.	12 months post procedure	No