Last updated on June 2016

A prospective study to compare the efficacy and safety of Laparoscopic Gastric Plication and Laparoscopic Adjustable Gastric Banded Plication procedures for patients with Severe or Morbid Obesity


Brief description of study

A prospective study to compare the efficacy and safety of Laparoscopic Gastric Plication and Laparoscopic Adjustable Gastric Banded Plication procedures for patients with Severe or Morbid Obesity

Detailed Study Description

Obesity is a growing national health problem that now affects over 35% of Americans and is the leading cause of preventable death. Obesity affects all organ systems and contributes to the cause of a multitude of medical problems such as cardiovascular disease, diabetes and sleep apnea [1]. It is defined as a body mass index (BMI) of equal to or greater than 30 kg/m2, and is directly correlated with increased risk of premature death. When the BMI reaches 40 or greater (morbid obesity), the NIH recognizes surgery as the only effective long-lasting treatment. Loss of 50% of excess weight is generally expected for greater than 5 years after surgery, as well as an improvement and/or resolution of co-morbidities such as diabetes, hypertension and obstructive sleep apnea [2]. With technical advancements and improved understanding of obesity, surgical treatment has become safer, with a mortality of less than1% and major morbidity of less than 10%.

The first advancement is the use of laparoscopy, which involves performing the same surgery with several small incisions rather than a large laparotomy incision. Small wounds result in significantly lower wound complications (5%). Less post-operative pain allows for early mobilization, which decreases pulmonary and thromboembolic complications. The second advancement is the integration of a comprehensive multidisciplinary bariatric program with surgery, including nutritional and psychological assessment, pre-surgical education & post-surgical support to increase the long-term success rate.

Traditionally, the primary mechanisms through which bariatric surgery achieves its outcomes are believed to be the mechanical restriction of food intake, reduction in the absorption of ingested foods, or a combination of both [3]. Adjustable gastric banding (AGB) and vertical sleeve gastrectomy (VSG) are restrictive approaches commonly used in bariatric practice. Although these procedures have proven to be good therapeutic options for some patients, they are not without significant complications, such as erosion or slippage of the gastric band or gastric leaks in VSG. Leaks in VSG pose a particularly difficult challenge when they occur near the Angle of His, potentially generating severe clinical conditions that require reoperation and may even cause death [4-5].

The Laparoscopic Gastric Plication (LGP) is a new restrictive bariatric surgical technique that has the potential to eliminate the complications associated with AGB and VSG by creating a restriction without the use of an implant and without performing gastric resection. LGP is notably similar to a VSG in that it generates a gastric tube by means of eliminating the greater curvature but does so without gastric resection. It is likely that LGCP greatly reduces the possibility for gastric leaks.

Clinical Study Identifier: TX8506

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Feather Wafford

Baptist Health Clinical Research Center & Lexington Cardiac Research Foundation
Lexington, KY USA
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