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

NCT ID: NCT01703546

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2015-11-30

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.

Conditions

Morbid Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LAGB & LGCP

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.

Group Type: EXPERIMENTAL

LAGB & LGCP

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Laparoscopic Adjustable Gastric Band & Gastric Plication

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Allison Barrett

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Ward, MD

Role: STUDY_CHAIR

North Shore LIJ Health System, Syosset Hospital, Director of Surgery

Allison Barrett, MD

Role: PRINCIPAL_INVESTIGATOR

North Shore LIJ Health System Syosset Hospital

Locations

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

Countries

United States

Other Identifiers

11-277A

Identifier Type: -

Identifier Source: org_study_id