negative study re : Lap banding

[jillrn 0]

Some people were asking about the negative study I found on lap band and here it is-- My Dr put me to ease though he was able to refute most of it with scientific data. This print is small hope you can read it! Dont know how to make it bigger but I will try! Jill

Laparoscopic Adjustable Silicone Gastric Banding (LASGB or LAP-BAND):<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p>

Recent advances in laparoscopy have renewed the interest in gastric banding techniques for the control of severe obesity. Laparoscopic adjustable silicone gastric banding (LASGB) using the adjustable LAP- BAND, has become an attractive method because it is minimally invasive and allows modulation of weight loss. The claimed advantage of LASGB is the adjustability of the band, which can be inflated or deflated percutaneously according to weight loss without altering the anatomy of the stomach. This method entails encircling the upper part of the stomach using bands made of synthetic materials, creating a small upper pouch that empties into the lower stomach through a narrow, non-stretchable stoma. The reduced capacity of the pouch and the restriction caused by the band diminish caloric intake, depending on important technical details, thus producing weight loss comparable to vertical gastroplasties, without the possibility of staple-line disruption and lesser incidence of infectious complications. However, distension of the pouch, slippage of the band and entrapment of the foreign material by the stomach have been described and are worrisome.<o:p></o:p>

The published results of LASGB have been highly variable, perhaps reflecting surgeons' relative lack of experience with this new bariatric surgical procedure. Several studies have reported high rates of complications associated with gastric banding include those associated with the operative procedure, such as splenic injury, esophageal injury and wound infection, and those occurring later, such as band slippage, reservoir deflation/leak, persistent vomiting, failure to lose weight and acid reflux (see e.g., Gustaavson, et al. 2002; Victorzon and Tolonen, 2001; Holeczy, et al., 2001). In studies reported to the FDA, 89% of patients experienced at least one side effect. These included nausea and vomiting (51%), heartburn (34%), abdominal pain (27%), and band slippage or pouch enlargement (24%). Nine percent of patients needed to have another operation to correct a problem with the device. Twenty-five percent had their entire Lap-Band Systems removed, mostly because of adverse side effects. In about one-third of those patients, insufficient weight loss was also reported as a contributing factor to the decision to have the Lap-Band removed.<o:p></o:p>

One of the claimed advantages of the LASGB procedure is its reversibility. Kellum (2003) noted, however, that “[t]he fact that two deaths in the FDA study occurred immediately following bend removal (one each from 'mixed drug intoxication' and multiple pulmonary embolism) suggest that secondary operations always carry significant risks.” <o:p></o:p>

In addition, the long-term safety of LASGB is undetermined. Kellum (2003) notes that one of the reasons that surgeons may want to proceed cautiously before adopting LASGB is the concern about the long-term problems related to apposition of a foreign body with the gastrointestinal tract. “Older surgeons will recall the many reports of migration and erosion associated with the Angelchick prosthesis for the treatment of esophageal reflux.” Several recent reports have detailed problems with LASGB slippage and erosion (Holeczy, et al., 2001; Silecchia, et al., 2001). Gustavsson & Westling. (2002) provided one of the few reports on the long-term outcomes with LASGB, and concluded that this procedure “will not stand the test of time.” The investigators reported that, after a median follow-up of 7 years, 58% of the patients who had undergone LASGB had been reoperated on, almost always with excision of the banding system and conversion to Roux-en-Y gastric bypass (RYGBP). The reasons for reoperation were esophagitis, band erosion, pouch dilatation, leakage from the balloon, and esophageal dilatation. A lower incidence of band erosion has been reported with the so-called Swedish adjustable gastric band due to the relatively lower pressure exerted on the stomach (Ceelen, et al., 2003). The Swedish adjustable gastric band has not been approved by the U.S. food and Drug Administration, and is currently under investigation. Although the Swedish adjustable gastric band offers the possibility of significant technical improvements over LASGB, it still represents a purely restrictive operation like the vertical banded gastroplasty, which most U.S. surgeons have abandoned in recent years.<o:p></o:p>

Because of the lack of direct comparative studies, the comparative efficacy of LASGB with established methods of obesity surgery is undetermined. In studies of laparoscopic adjustable silicone gastric banding reported to the FDA, the mean excess weight loss was 36.2% at 3 years. This figure contrasts with a 40-60% excess weight loss reported in other series of VBG and 50% for RYGB. (Maclean, et al., 1990; Willbanks, 1987; Melissas, et al., 1998) and 50% for gastric bypass (Griffen, et al., 1987; Pories, et al., 1995). Kellum (2003) notes that multiple reports have demonstrated the superiority of RYGB over VBG. Since LASGB, like VBG, is a purely restrictive operation, “one would expect that laparoscopic Roux-en-Y gastric bypass would yield superior long-term weight loss results when compared to laparoscopic Lap-Band placement.” Kellum (2003) cited the report of Belachew and Monami (1996) that concluded that LASGB had an identical weight loss curve to the open VBG performed by the same surgeons. Kellum (2003) concluded that “t is obvious that only a prospective, randomized series would definitively establish which operation is best in terms of safety and efficacy.” <o:p></o:p>

Investigators from the Medical College of Virginia, one of the eight original U.S. centers performing LASGB, published their results. (Demaria, et al., 2001). The investigators “did not find LASGB to be an effective procedure for the surgical treatment of morbid obesity.” At the time of the report, LASGB devices had been removed in 41% patients, either because of inadequate weight loss or intolerable side effects. In 71% of patients with bands in place who underwent long-term evaluation, a significantly increased esophageal diameter developed; of these, 72% had prominent dysphagia, vomiting, or reflux symptoms. Of the patients who still had bands in place, more than one-third were reported to currently desire removal and conversion to RYGB for inadequate weight loss. About a third of the remaining patients have persistent severe obesity at least 2 years after surgery but refuse to undergo further surgery or claim to be satisfied with the results. Overall, only about 10% patients who underwent LASGB achieved a body-mass index of less than 35 and/or at least a 50% reduction in excess weight. The authors predicted that the overall need for band removal and conversion to RYGB in their series will ultimately exceed 50%. The researchers concluded that more study is required to determine the long-term efficacy of LASGB. <o:p></o:p>

Reporting on the results of a systematic review of the published medical literature on obesity surgery, Gentileschi, et al. (2002) concluded that “the efficacy of [LASGB] cannot be determined because of poor evidence.” An assessment of the literature on obesity surgery conducted for the National Institute for Clinical Excellence concluded that LASGB is both more costly and less effective than RYGB for severe obesity (Clegg, et al., 2001). An assessment of LASGB by the Australian Safety and Efficacy Register of New Interventional Procedures - Surgical (ASERNIP-S) concluded that the “[l]ong-term efficacy of laparoscopic gastric banding remains unproven and further evaluation by randomised controlled trials is recommended to define its merits relative to the comparator procedures” (Chapman, et al., 2002). The French National Agency for Accreditation and Evaluation in Health (ANAES, 2001) concluded that “n view of the inadequate long-term evaluation of either efficacy or inherent risk of gastroplasty rings (notably risks relating to how the prosthetic material is tolerated, and risk of migration of the ring into the stomach), the working group was concerned about the extensive and unevaluated diffusion of this technique which is currently taking place.” An assessment conducted by the BlueCross BlueShield Association Technology Evaluation Center (2003) stated that there is insufficient evidence to conclude that LASGB either improves net health outcomes or whether it is as beneficial as current established surgery, RYGB. “For laparoscopic gastric banding, the available evidence suggests that weight loss at one year is less than that achieved with gastric bypass. More limited evidence on three-year weight loss suggests that this difference in weight loss may lessen over time. Early adverse event rates are low following laparoscopic gastric banding, and are probably lower than gastric bypass. There is a higher rate of long-term adverse events, and there are a number of potentially serious long-term adverse events such as band slippage or erosion. The incidence of slippage of the device from its intended location, or erosion through the gastric wall increases over time, and can result in visceral organ damage, abdominal pain, and intestinal obstruction. The available data are not sufficient to determine the rates of these longer-term adverse events with confidence.” An assessment conducted by the Australian Medical Services Advisory Committee (2003) concluded that LASGB is as effective as VBG but less effective than RYGB in terms of weight loss. The Canadian Coordinating Office of Health Technology Assessment (CCOHTA, 2003) concluded that “[l]ong-term outcomes data on the effectiveness and safety of the laparoscopic adjustable gastric banding procedure is needed.” In a systematic review of the literature on LASGB, Chapman, et al. (2004) concluded “the long term efficacy of LB remains unproved, and evaluation by randomized controlled trials is recommended to define its merits relative to the comparator procedures.”<o:p></o:p>

An assessment of LASGB prepared for the California Technology Assessment Forum (Tice, 2004) concluded that this technology did not meet CTAF criteria. Regarding comparisons of LASGB with other established bariatric surgical procedures, the assessment found:<o:p></o:p>

Thus, the mean excess weight loss following open or laparoscopic ASGB appears to be roughly equivalent to vertical banded gastroplasty, but significantly less than Roux-en-Y gastric bypass. None of the comparative trials reported on reductions in co-morbidities. Additionally, in spite of lower peri-operative complications, there seem to be more, and more serious, late complications following ASGB. The lack of well controlled, randomized studies precludes any meaningful assessment of the strengths and weaknesses of LapBand compared with Roux-en-Y gastric bypass. Therefore, it cannot be concluded that LB improves net health outcomes as much as or more than established alternatives of roux-en-Y gastric bypass or vertically banded gastroplasty.<o:p></o:p>

An evidence review completed by the Ontario Ministry of Health and Long-Term Care (2005) concluded that, “[r]egarding specific procedures, there is evidence that malabsorptive techniques are better than other banding techniques for weight loss and resolution of comorbid illnesses.”

["with the band" 1]

That is all very interesting. I pray none of that happens to any of us.

[fun4matt 0]

WOW I read that whle thing. What I got from it was banding was not a good thing. and for weight loss Roux-en-y is better. No body is going to mess with my stomach. only reversable stuff,.

[jillrn 0]

Well Matt my dr basically said--the study was older and they were having some problems with slippage and that is basically resolved now due to a new approach -- he explained the approach but I am not going to try as it is long. He also said they study was somewhat slanted and actually I believe him b/c I found it on a insurance co web site! LOL (my first problem) and that insurance co does not pay for it. He said he has never had one slip or erode yet--but he does know of some erosions but in these cases he said the people were fine and losin weight and decided to keep the band! Hmmm sounds a little dangerous to me! He said some of the patients included in the study should not have been b/c they lumped a few different procedures together that dont coinside (sp?) anyway basically they arent comparing apples to apples or chocolate to chocolate which ever you prefer! =)

[MerryHearted 20]

I know that the incidence rate of slippage is way down since they started stitching the stomach up around the band. And there are a lot less tubing leakage problems since they changed the design of how the tubing connects to the port. So I think your doc is right Jill -- the stats have probably changed since they've made improvements in the band and the band surgery. Certainly the stats presented by the surgeons that do the procedures are much more favorable. (natch, since they want you to have the surgery)

I do know there are ongoing studies (I'm in one of them). Obviously I hope long term results aren't as dire as the study says!

I always get irritated when they compare weight loss in the first year between the band and the gastric bypass. Of course gastric bypass patients lose more during the first year. I'd like to see studies that show weight at 5 and 10 years out compared to starting weights.

[fun4matt 0]

Molly how did you get on a study, I would love a discounted band for a study.. any suggestions.

[PamRN 0]

From what I read I see that there are some suggestions that banding MAY not be as good as bypass, and MAY have more complications, and MAY not have as much weight loss.... but they need to do studies to prove that theory. THAT means, it's NOT a proven fact, it's just opinions. If you read this carefully, you'll find it contradicts itself somewhat. It theorizes that there MAY be less weight loss, and there MAY be more side effects. But over a period of years, the amount of overall weight loss is closer to bypass. Look at the news today... 1 in 29 chance of bypass death? I'll take 2 in 100 chance of reflux over 1 in 29 of death.

These quotes tell me a lot about the whole article.

<<"that concluded that LASGB had an identical weight loss curve to the open VBG performed by the same surgeons. Kellum (2003) concluded that “t is obvious that only a prospective, randomized series would definitively establish which operation is best in terms of safety and efficacy.” >>

<<"The researchers concluded that more study is required to determine the long-term efficacy of LASGB." >>

<<“For laparoscopic gastric banding, the available evidence suggests that weight loss at one year is less than that achieved with gastric bypass. More limited evidence on three-year weight loss suggests that this difference in weight loss may lessen over time.">>

<<" Early adverse event rates are low following laparoscopic gastric banding, and are probably lower than gastric bypass.">>

[DrHekier 0]

Since the Band has only been FDA approved in the US since 2001, longer term reports from the US are only beginning to come out now.

As I posted in another thread, in this month's Journal of the American College of Surgeons, there is a report from a group in Atlanta, detailing their results with over 1000 bands.

See the thread :

http://www.lapbandtalk.com/showthread.php?t=10835

No operative procedure is without risks, but I think the data clearly shows that risk of severe complications, such as death, is much lower with the Band than with GB.

To each their own, when GB works, it works great. My personal opinion is that the Band has a much better safety profile for similar results.

[wendyr 0]

Reading that report is not very encouraging after just having the band two weeks ago put on. I think it is an old report and thats why we have to follow the doctors orders so that none of that happens.

[jillrn 0]

Off topic-- Dr Hekier--Texarkana eh?? I have a good friend that lives there she is a nurse too and has had GB. I just love the name Texarkana!

Do you know of where I can get copies of more medical journals and studies on Obiesity Surg-- esp LB??? thanks Jill

[ReneBean 3]

Here's the link to the Journal of Obesity Surgery:

http://www.ingentaconnect.com/content/09608923

You can access the abstracts for free.

:]

[MerryHearted 20]

Molly how did you get on a study, I would love a discounted band for a study.. any suggestions.

My surgeon's office just happened to be signed up to offer new bandsters to join the study. However, there's no discount for the band that I know of for this study. My insurance covered it for me, but they were charged full price. I believe it's Inamed that's running the study.

[DeLarla 22]

I think there's a lot of common sense and truth about it.