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Patient Receives New Incision-Free Weight-Loss Surgery E-mail
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The first patient in the New York City area received incision-free surgery for obesity as part of the ongoing multicenter TOGA Pivotal Trial at New York-Presbyterian Hospital/Columbia University Medical Center.


Drs. Marc Bessler and Daniel Davis performed the TOGA Procedure (for "transoral gastroplasty"), which, like other obesity procedures, is designed to alter the patient's stomach anatomy to give them a feeling of fullness after a small meal. The difference is that TOGA was performed under direct endoscopic visualization with specialized instruments passed into the stomach through the mouth without any incisions.

"This new surgery is an exciting option for severely overweight patients who do not respond to diet, exercise and drug therapy. We hope to show that, like other weight-loss operations, the TOGA procedure will help them to lose weight and improve their health," says Dr. Bessler, principal investigator and director of laparoscopic surgery and director of the Center for Obesity Surgery at NewYork-Presbyterian/Columbia. He is also an assistant professor of surgery at Columbia University College of Physicians and Surgeons.

In the new procedure, the surgeon introduces a set of flexible stapling devices through the mouth into the stomach, and uses them to create a restrictive pouch that is intended to catch food as it enters the stomach, giving patients a feeling of fullness after a small meal.

"The benefits of an endoscopic approach are less pain, quicker recovery, shortened hospital stay and decreased complications, as well as a lack of scarring," says study co-investigator Dr. Davis, a surgeon at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of surgery at Columbia University College of Physicians and Surgeons. "Eventually, TOGA may also be an option for patients who are unable or unwilling to undergo more invasive surgery."

A 2006–2007 pilot study at medical centers in Mexico and Belgium found that patients receiving the TOGA procedure lost more than a third of their excess body weight. By 12 months, their excess weight loss averaged almost 40 percent.

In the current study, two out of three patients will receive the TOGA procedure, while one out of three will receive a control procedure, which is similar to the TOGA procedure except no pouch is created. After one year, patients will be told which procedure they received, and patients who received the control procedure will be offered the TOGA procedure if they continue to meet the treatment criteria.

Patients enrolled in the clinical trial will be followed for a minimum of 12 months. All study-related medical care will be provided at no charge to the patient, and patients will receive medically supervised nutritional counseling.

The purpose of the TOGA Pivotal Trial is to evaluate the safety and effectiveness of the TOGA procedure. Investigators will be evaluating weight loss and changes in obesity-related health problems such as Type 2 diabetes, cholesterol levels and hypertension. If successful, it's hoped that this study will result in FDA approval of the TOGA System, which will allow patients to be treated outside of clinical trials. Currently, the TOGA System is an "investigational device" and can only be used in clinical studies.

NewYork-Presbyterian/Columbia plans to enroll at least 15 patients out of a total 275 patients to be enrolled at centers nationwide. Volunteers must be 18 to 60 years old and 100 pounds or more overweight, and must have been unsuccessful with non-surgical weight-loss methods. For more information they may call toll free (866) 678-8399.

About Obesity

"Obesity " specifically refers to an excessive amount of body fat. According to the National Institutes of Health (NIH), a person is considered "obese" when he or she weighs 20 percent or more than his or her ideal body weight. Most health care professionals agree that men with more than 25 percent body fat and women with more than 30 percent body fat are obese. At that point, the person's weight poses a real health risk.

Obesity becomes "morbid" when it significantly increases the risk of one or more obesity-related health conditions or serious diseases.. Morbid obesity sometimes called "clinically severe obesity" is defined as being 100 lbs. or more over ideal body weight or having a Body Mass Index (BMI) of 40 or higher. BMI is more commonly used by health care professionals to determine the effect of body weight on the risk for some diseases.

Obesity is a global disease affecting over 300 million people, according to the World Health Organization. According to the NIH Consensus Report, 97 million Americans, more than one-third of the adult population, are overweight or obese. Obesity is more than a cosmetic problem. Many serious medical conditions have been linked to obesity, including hypertension, cardiovascular disease, type 2 diabetes, stroke, sleep apnea , osteoarthritis of weight-bearing joints and certain types of cancer. The cost of obesity to society is staggering. According to the Surgeon General “Obesity, with its rank among the top ten diseases, may be America's number-one contributor to health care costs.” Louisiana State University researchers estimate that “the direct costs of obesity in the United States is now at 39.3 billion dollars a year. That is more than 5% of all medical costs.” (source: http://www.obesityhelp.com/content/aboutobese.html)

Men who are obese are more likely than non-obese men to develop cancer of the colon, rectum, or prostate. Women who are obese are more likely than non-obese women to develop cancer of the gallbladder, uterus, cervix, or ovaries. Esophageal cancer has also been associated with obesity.

Other diseases and health problems linked to obesity include:

  • Dyslipidemia/High Cholesterol
  • Depression
  • Gastroesophageal reflux/Heartburn
  • Infertility
  • Urinary stress incontinence
  • Menstrual irregularities
  • Lymphedema

Health care providers generally agree that the more obese a person is, the more likely he or she is to develop health problems.

About Surgical Weight Loss Programs

Bariatric surgery, or weight loss surgery, is a method of weight loss for the severely obese who are unable to lose weight by any other means. Bariatric surgery includes a spectrum of procedures from restrictive to malabsorptive to those combining the two. Restrictive procedures such as Adjustable Gastric Banding (LapBand®) and Vertical Banded Gastroplasty (VBG) reduce the size of the stomach, and malabsorptive and combined procedures such as Roux-en-Y Gastric Bypass (RGB),Biliopancreatic Diversion, Fobi Pouch and Duodenal Switch (DS) reduce the body's ability to absorb calories and nutrients from food.

Traditional open weight loss surgery

Once the only method used for surgical procedures, traditional open surgery involves making a 10- to 12-inch incision to access the stomach and intestines. Depending on surgeon expertise incision size can vary on the open surgeries.

Minimally invasive, or laparoscopic, weight loss surgery

In minimally invasive, or laparoscopic, surgery, the surgeon uses five or six small incisions (each 1/4 and 1/2 inch long) to gain access to the stomach and intestines. The laparoscope is a telescope attached to a video camera. Such minimal-access surgery offers a faster, less painful recovery. But not everyone qualifies for less-invasive surgery. It depends on medical history, surgical difficulty, and body shape.

The surgeon inserts the laparoscope through the incisions and gets a magnified view of the patient’s organs on a television monitor. The entire operation is performed inside the abdomen after gas has been inserted to expand the abdomen.  Minimally invasive surgery techniques have reduced hospital and recovery times for many operations. The incidences of complications have also been reduced.

Both approaches have excellent long-term results, allowing patients to lose 80-90% of their excess weight in 10-24 months, with most patients maintaining 48-74% of their initial weight loss after five years. However, there are risks involved, therefore surgical options are usually restricted to patients who cannot lose weight on one of the dietary programs.

 
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