For the morbidly obese, bariatric surgery can be the course of last resort.
It is a major step, not for the irresolute or faint of heart. And reputable surgeons who perform this procedure set strict standards for all potential candidates as well as in-depth pre-operative psychological screening.
Dr. Ray Kruger of Wareham Surgical Associates laid out all of these caveats to potential candidates for the surgery recently during a recent one-hour informational seminar in Hyannis.
"The National Institutes of Health set standards for these procedures in 1999," he told the small but attentive audience before proceeding to his lecture, slide and video show and follow-up Q-and-A.
The physical standards are pretty clear-cut.
The patient must be more than 100 pounds overweight or show a Body Mass Index (BMI) of 40 percent or more above normal. (Twenty percent over normal is considered obese,) They do not take patients weighing more than 350 pounds because of the higher risks involved. But they will accept cases where the BMI is 35 percent above normal if the co-morbidity elements are particularly life-threatening. Potential patients also must document that they have tried and failed in more traditional efforts to lose weight and maintain a loss.
They also will not take smokers, drug abusers or those who have undergone prior stomach surgery.
Bariatric surgery is not a cosmetic procedure, practitioners of this specialty point out. Body fat is not removed.
Rather, the body's ability to ingest and process food is surgically restricted. "Co-morbity" is the decisive factor that justifies insurance coverage.
Obesity, it is well known, causes a host of physical problems, some of which are heart disease, diabetes, high cholesterol levels and it's even deemed a factor in some cancers. In the morbidly obese, these conditions are exacerbated, often to a life-threatening degree.
"We take patients with these medical problems and they'll lose 100 pounds and 95 percent of those health care problems within a year after surgery," Dr. Kruger related.
He says that in 80 percent of his cases, the weight loss will be permanent as compared to 10 percent of those who lose weight with the help of current drugs.
There are three basic types of procedure, Dr. Kruger explained.
Even with the advent of laparoscopic or small-incision techniques, Dr. Kruger admits, "This is high-risk surgery with challenging patients and they have to weigh the risks against the risks of being morbidly obese and the co-morbidities. But for most patients, this is their last chance for a normal life."
Candidates are required to enroll in the pre-operative programs involving a psychologist. This costs $550 up front and is not covered by insurance. (For the uninsured, Dr. Kruger estimates the cost of actual surgery at $20,000.) The surgery is performed at Tobey Hospital in Wareham, the only facility in this region to have made the investment for Dr. Kruger and his partner, Dr. Tom Streeter, and their team to conduct these procedures. The patients usually are hospitalized for three days "and they usually can be back at work in a week," Dr. Kruger says.
But that's just the beginning. You don't lose weight from the operation. Following surgery, patients still must embark on a lifetime regimen of exercise and a very carefully monitored diet. Certain foods and beverages (high sugar, soda) that can cause leakage are prohibited …forever. It takes about a year to get back to "normal" weight. The good news is the high rate of success in maintaining that loss.
Dr. Kruger says that nationally the mortality rate is one half of one percent (one per 200 patients), which he says is "about the same as for gall bladder surgery" and lower than for some other more common procedures.
Other problems can involve leakage, which Dr. Kruger admits "can be catastrophic" among the obese. But that is why patients are required to undergo frequent monitoring for several years; although the frequency does diminish slowly after the first year or so.
In addition to strict diet and exercise, patients "still require oversight for the rest of their lives," Dr. Kruger says.
This high-maintenance monitoring before and for years after the surgery is one reason Dr. Kruger touts the convenience of staying local as an alternative to heading to Boston.
(Dr. Kruger can be reached at 508-295-3900.)
Like Ponce de Leon seeking his Fountain of Youth, the quest is never-ending for a pill that will help those of us who have trouble losing weight...and then keeping it off.
Some 20 Cape Codders are currently involved in clinical trials of a medication that may do just that.
The trial of this appetite suppression medication is one of many currently being conducted by the Clinical Research Center of Cape Cod, Inc., of West Yarmouth.
CRC is an independent research facility owned by Susan Cannon of Barnstable Village. She previously worked for Clinical Studies of Cape Cod on Whites Path during various incarnations under different ownerships. When that facility was closed down by its previous corporate masters, she set up on her own three years ago.
Ms. Cannon, a registered nurse, subsequently created a partnership with her husband, Ted, who operates Diagnostic Support services. They're different entities, but share office staff. Clinical Research Center has four nurses on staff and works cooperatively with several local physicians.
The anti-obesity drug in question is now in its second year of a nationwide two-year Phase II Trial, which is designed to see how the medication works. It's a double-blind test, meaning neither the tester nor the subjects know who's getting the medication and who gets the placebo. (Following the completion of the test, the blind is broken and results are forwarded to the subjects and their primary care physician.)
The studies are paid for by the drug companies involved and supervised by an Institutional Review Board, which, Ms. Cannon says, "acts as the patients' advocate."
Patients receive a stipend of $25 a visit or more, usually paid yearly or at the end of the trial. Ms. Cannon says there's never any shortage of volunteers for these trials, which is good because of the stringent screening process that eliminates most candidates for any given study. Only adults are accepted and cancer patients are disqualified. Those accepted then are required to peruse and sign a lengthy consent form. Their participation, of course, is confidential. About 150 Cape Codders currently are enrolled in various CRC clinical trials.
The new anti-obesity product from Merck already has been approved by the federal Food and Drug Administration for use in combating drug addiction. The medication, which has no brand name as yet, somehow decreases the pleasurable effect the subject receives from those drugs. Merck would like to see if it also works the same way to remove or decrease the same high some get from a well-filled stomach.
It's way early, Ms. Cannon says-and there's still that old "placebo effect," in which if you think you're getting a drug that will make you feel better, you'll feel better-"but after 10 months some of our people say they've lost 30 pounds." All participants, even those who might be on the placebo, also must follow a low-calorie diet and exercise regularly.
The other side, though, is that at the beginning of the test "some people thought they could start eating anything they wanted, that the medication was some kind of magic bullet. And there is no magic bullet," Ms. Cannon concluded.