Gastric Band Failure Data Important for Comparisons w/ band-Bypass/% EBWL@ 3yr=73 RNY...

FYI, as always statistics for me can be manipulated and reading this seems to validate that. I am sure tomorrow we will hear even something different! Buyer beware no matter what you choose! Jamie
Gastric Band Failure Data Important for Comparisons With Gastric Bypass
http://www.medscape.com/viewarticle/576331?sssdmhm1.361387&src=nldne

Jacquelyn K. Beals, PhD





June 19, 2008 (Washington, DC) -- A study comparing the efficacy of laparoscopic adjustable gastric band (LAGB) treatment with laparoscopic Roux-en-Y gastric bypass (LRYGB) in terms of loss of excess body weight found that the treatment outcomes differed significantly when failures were included but not when failures were excluded. Failures included explantation of LAGB, reversal of LRYGB, or conversion of either treatment to another bariatric procedure.

Presented here at the American Society for Metabolic & Bariatric Surgery 25th Annual Meeting, the study analyzed data from all patients (N = 1280) *****ceived LAGB (n = 576) or LRYGB (n = 704) as their primary treatment during a period of 3 years, 7 months. Age and sex distribution were equivalent in the 2 groups. Average body mass indexes were 45.6 ± 0.26 kg/m2 (LAGB) and 47.7 ± 0.28 kg/m2 (LRYGB) (P < .001).

Medscape General Surgery spoke with coauthor Richard S. Flint, MD, a fellow in the group of David B. Lautz, MD, director of bariatric surgery, Brigham & Women's Hospital, Harvard Medical School, Boston, Massachusetts, who presented the study.

"You've got some studies saying that the bypass is more effective. However, the more recent evidence is saying that the band is just as effective as a bypass," said Dr. Flint. "And considering it has less perioperative risk, that has quite a significant influence on what operation a patient may choose. So what we're trying to identify is what the real answer is here."

The study assessed excess body weight loss (EBWL) 1, 2, and 3 years after each procedure and analyzed the effect of carrying forward the final weight loss data of patients who dropped out of the study. At 3 years' follow-up, the percentage EBWL for the 2 treatments appeared to be converging when failures were excluded (P = .059). With failures included, percentage EBWL for each treatment stabilized after 1 year, and mean percentage EBWL at 3 years was 73.3 in the LRYGB group vs 37.0 in the LAGB group (P < .001).

A second part of the study increased follow-up and used statistical modeling to deal with missing data. In this analysis, the percentage EBWL achieved with LYRGB was significantly greater than for LAGB and was maintained over time.

Investigators concluded that proper handling of missing data, including treatment failures, is necessary when comparing bariatric procedures. "I think what we've shown in our data is that if you don't handle the missing data and treatment failures correctly, then you can actually get a skewed influence," said Dr. Flint. "And telling a patient that they're getting the same result as a bypass when they're not actually getting the same result as a bypass...they may be going and unwittingly get discouraged. And that may jeopardize the band's efficacy anyway," he said.

"No one can accurately predict what operation suits what patient.... [T]herefore, it's really left to the patient to decide," noted Dr. Flint. "It's very important that you give them accurate facts. If you've got proponents of 1 operation saying, well, this is the only operation to do, then you're not giving the patient a fair go."

Victor F. Garcia, MD, a pediatric surgeon, director of Trauma Services at Cincinnati Children's Hospital Medical Center Trauma Services, and associate surgical director for the Cincinnati Children's Comprehensive Weight Management Center, Ohio, discussed the study following Dr. Flint's presentation.

"I think this is an incredibly important study of seminal observations being made on patients lost to follow-up," noted Dr. Garcia. Focusing on the challenge of maintaining high levels of follow-up, he asked: "How can we be confident, then, that those lost to follow-up...do not differ from those *****turn for follow-up?.... [T]he question is, what can you offer them?"

Dr. Garcia mentioned 2 "perhaps controversial approaches" -- public performance reporting or compensation for patients who follow-up. But "how does [this] stipulate or consolidate problems that patients already have?" Dr. Garcia asked.

Dr. Flint concluded: "What we're trying to say is, 'What is the real answer here?' What happens to those treatments in the patients who fail, and how does that influence the result? What we're trying to say is that it does significantly influence the results."

Dr. Flint and Dr. Garcia have disclosed no relevant financial relationships.

American Society for Metabolic & Bariatric Surgery 25th Annual Meeting: Abstract PL-13. Presented June 18, 2008.