Re: Blind Study

[Guest guest]

In a message dated 8/26/01 7:44:18 AM Eastern Daylight Time,

duodenalswitch writes:

<< would agree to having a card drawn during the procedure to

determine whether I would wake up with the RNY or the DS. I am

wondering what some of you think about this type of uncertainty. >>

I would not do this for 10 million dollars. That is stupid and why is it

necessary to compare 2 surgeries to have you taking a chance (worse than the

lotto) and then find out when its all over what you got?

Sounds ridiculous to me.

Carole

[Guest guest]

In a message dated 8/26/01 4:15:09 AM Pacific Daylight Time,

aveil@... writes:

<< Hi all. I am new to this group. I may be offered the chance to

paticipate in a blind research study comparing the distal RNY to the

DS. It would require that I agree to an open procedure, but also that

I would agree to having a card drawn during the procedure to

determine whether I would wake up with the RNY or the DS. I am

wondering what some of you think about this type of uncertainty. Any

constructive comments are welcome. Thanks!

>>

So you dont know which procedure you'd have?? Hmmmm I don't think I'd do that

unless it was the only way I could afford to have the surgery. Course I am a

die hard DS fan so really, you're the only one who can decide what you really

want. If you are okay with it...then go for it! If you really want the

DS...then I'd go the traditional route!

aJ

[Guest guest]

In a message dated 8/26/01 7:15:35 AM Eastern Daylight Time,

aveil@... writes:

<< I would agree to having a card drawn during the procedure to

determine whether I would wake up with the RNY or the DS. I am

wondering what some of you think about this type of uncertainty. Any

constructive comments are welcome. Thanks! >>

Does this mean that you don't have to pay for the surgery as a result?

Sheryl

[Guest guest]

In a message dated 8/26/01 7:44:14 AM, duodenalswitch writes:

<< Hi all. I am new to this group. I may be offered the chance to

paticipate in a blind research study comparing the distal RNY to the

DS. It would require that I agree to an open procedure, but also that

I would agree to having a card drawn during the procedure to

determine whether I would wake up with the RNY or the DS. I am

wondering what some of you think about this type of uncertainty. Any

constructive comments are welcome. Thanks!

>>

: I would NOT want to mess with a distal RNY. I can some advantages

to having a proximal RNY (less malapsorption, etc.) but really none to the

distal RNY when compared to the DS. I would do my research and see if you

can live with a distal RNY. YOu will experience similar malapsorption

problems but will NOT be able to get as much nutrition in. I would run, not

walk, away from this kind of study. The future implications for your health

and well-being are too precious to let someone else decide this for you.

I would think it would be quite unethical, actually and wonder if this is

really possible. I can understand a study of post-op distal RNY and Dsers,

but not to be so irresponsible as to decide someone's surgery for them...

all the best,

[Guest guest]

> Hi all. I am new to this group. I may be offered the chance to

> paticipate in a blind research study comparing the distal RNY to the

> DS. It would require that I agree to an open procedure, but also that

> I would agree to having a card drawn during the procedure to

> determine whether I would wake up with the RNY or the DS. I am

> wondering what some of you think about this type of uncertainty. Any

> constructive comments are welcome. Thanks!

, I'm all for helping the cause of medical research, but I would

*never* agree to this type of arrangement unless the Distal RNY and the

DS were equal options in my mind. I'm not sure that anyone who does the

research and learns about both procedure can ever feel completely

neutral. This is a lifelong decision, and one that is much too big to

leave to chance. Please make sure that you are 100% fine and dandy with

living with either procedure before you agree to anything like this.

M.

---

in Valrico, FL, age 39

Lap DGB/DS by Dr. Rabkin 10-19-99

http://www.duodenalswitch.com

Starting weight 299, now 156

Starting BMI 49.7, now 26.0

Starting size 26/26, now 10/12

Direct replies: mailto:melanie@...

_________________________________________________________

[Guest guest]

This sounds completely unethical. It is a fundamental principle of medical

treatment that the patient give informed consent after the risks and

benefits are explained. Somewhere in there is the notion that the patient,

not the doctor, has the ultimate decision as to which treatment is given.

This isn't a drug trial in which a patient might get the drug, but might get

a placebo. At least the placebo does no harm. In this case the patient

will get one operation or the other, but with either option she will get

treatment of some type. She will live the rest of her life with the results

of a decision made by pulling a slip of paper out of a bowl. If she is fine

with either alternative, that is one thing. If she definitely prefers

either the distal RNY or the DS, the right to make that choice, and have her

preference honored, is being stripped from her. Even if the particular

patient agrees to it, it is not the way medical treatment is or should be

administered.

Outrageous.

[Guest guest]

In a message dated 8/26/01 7:49:39 AM Eastern Daylight Time,

melaniemag@... writes:

> This is a lifelong decision, and one that is much too big to

> leave to chance. Please make sure that you are 100% fine and dandy with

> living with either procedure before you agree to anything like this.

>

I agree with this 110%. This is your life. While both surgeries are good

in my opinion, they are different. You need to figure out which is better

for you. I wouldn't leave it up to chance.

[Guest guest]

This might shock you but most patients WLS patients do not have as

much information as the members of this group have. Add to that the

simple fact that there a lot of our post-op suggestions are either

the same or quite similar. A lot of RNY people do not know that

there are different types of wls. So they could easily do a blind

study based upon that. The part that is unethical is that if you

were to have a problem it would be crucial that you inform your

attending physician what type of surgery you had. I carry a

business card from my surgeon that illustrated my surgery in detail

and provides instructions on contacting the surgeon in the event of

an emergency.

> >Hi all. I am new to this group. I may be offered the chance to

> >paticipate in a blind research study comparing the distal RNY to

the

> >DS.

>

> " Blind distal RnY vs. DS study " is almost an oxymoron (a

> self-contradictory name; examples -- " business ethics " or " military

> intelligence " ). That's because once you recover from the surgery,

> your life instructions and are different. With the RnY you will

risk

> blocking your stoma (the slit from you egg-sized stomach pouch to

> your intestinal limb) if you do not chew your meat 25 times or if

you

> eat fibrous veggies like celery. With the DS, you will have no such

> restrictions. So, the research subjects (the patients) will know

> what procedure they will have received, unless they are totally

> dense, and their doctors will have guessed, also (of course, doctors

> only have to be uninformed of who got what in " double-blind "

> studies). The study will, therefore, by definition, no longer be

> " blind " because behavioral variations will have been introduced by

> patients' knowledge of what procedure they had received.

>

> My 2¢.

>

> --Steve

> Yeah, but you don't find out what you " won " until you open your eyes

and they

> tell you........ " oh, by the way, you got the RNY, now be sure you

chew your

> food till it is mush, don't drink any water with that food, and let

us know

> how your pouch is doing

> and if your stoma gets blocked, we can re-open it later, etc....... "

> Or " make sure you eat protein first, take all the vitamins necessary

daily

> and you can pretty much eat whatever you can handle, although not as

much

> because your stomach is smaller..... "

> Wow - it will be scarey enough to wake up from surgery adjusting to

the fact

> that you really went through with it, but to not know WHAT you just

went

> through!

> I don't understand why this would be necessary unless the people

running it

> want to do an even number of both surgeries and are using this as an

excuse

> to get some RNYs in when most people want DS.

> (I envision -

> Dr.s in a private meeting " Well, seems everyone wants the DS now and

we only

> do the RNY - I know! Lets have a " blind study " and tell the patient

they

> might get one or the other but they don't know till they wake up

what they

> got! And charge regular for it, but make it seem like its in the

best

> interests of medical science!)

>

> A study can be done on the differences between the 2 surgeries just

by

> looking at the records of those who have had each voluntarily.

Seems there

> are more than enough " subjects " already for that.

> Just my opinion,

> Carole

[Guest guest]

There are a few facts missing here. Like do they pay for the

surgery? And if you were to have RNY would they leave your pyloric

valve in tact?

All of this aside, I think that this study is vital to getting

insurers to cover DS without the " investigational crap " that they give

now. I also think that it is a great way for the world to find out the

long term benefits of DS. The more published data there is out there

the more likely that people will choose DS over RNY.

That said, I couldn't do it not even for a lot of money. I love my

steak and not to be able to enjoy a good steak for atleast a year

would be akin to agony. Then again if you had told me pre-op that I

would hate chocolate post-op I would have laughed you out of the room.

my rambling 2 cents.

Tina

> Hi all. I am new to this group. I may be offered the chance to

> paticipate in a blind research study comparing the distal RNY to the

> DS. It would require that I agree to an open procedure, but also

that

> I would agree to having a card drawn during the procedure to

> determine whether I would wake up with the RNY or the DS. I am

> wondering what some of you think about this type of uncertainty. Any

> constructive comments are welcome. Thanks!

[Guest guest]

-

Do you pay for this surgery?

Who performs it? Where will this take place? Why does it have to be blind?

They can't just have a good RNY surgeon and a good DS surgeon track thier

cases?

What about complications? You surely would find out what you had done if

you had complications and needed tests and care?

What will be the length of the CC and ailmentary limb? Who is sponsoring

this study? Is this a center who perhaps promotes or does one particular

surgery prominately? I would be concerned that the surgeries could be

tweaked to favor one or the other. Such as the stomach size, the common

channel length ect....

You have alot of questions to ask!!! Let us know!!

Pammi

_________________________________________________________

[Guest guest]

Are you absolutely sure you trust the credentials of the

institution/practicioner who suggested this? It sounds like a very

strange notion, to say the least.

I've heard - I'm afraid I don't remember the source - that the

complexity of BPD/DS ranks about the same as open-heart surgery. If

that's the case, it's probably pretty much the same for a distal RNY.

I can't think of a more drastic procedure you can contemplate than

this. What kind of institution/physician is suggesting that you

embark on such an enterprise under these conditions? Who is

sponsoring this study? Why? How are they able to draft an informed

consent form for an enterprise like this? There is a lot of data

available, inter alia at the International Bariatric Surgery

Registry, regarding the outcomes of various procedures. Surgeons have

numerous other sources of information available, as well.

Why would one institution/physician feel a need to conduct this sort

of comparison study independently, and under such odd conditions? The

notion of a surgeon " drawing a card " to decide which procedure to

perform - just describing it to you in those words should set every

alarm off in your head. Do you really want someone operating on you

who describes the way he/she will decide what procedure to perform

as " drawing a card? "

There is something exceedingly strange and extremely unsettling about

this. If you cannot independently and securely establish the

credentials of whoever is offering this - I would run - not walk - in

the direction of the nearest reputable physician and hospital. This

is your life we're talking about.

Aviva

> Hi all. I am new to this group. I may be offered the chance to

> paticipate in a blind research study comparing the distal RNY to

the

> DS. It would require that I agree to an open procedure, but also

that

> I would agree to having a card drawn during the procedure to

> determine whether I would wake up with the RNY or the DS.

[Guest guest]

Tina, You are much less suspicious than I... I dont think this is

legitimate. Either this person is being pranked or all of us are. I

cant imagine that such a thing would be either ethical or legal.

JMHO,Meli

-- In duodenalswitch@y..., dreamweavergirlus@y... wrote:

> There are a few facts missing here. Like do they pay for the

> surgery? And if you were to have RNY would they leave your pyloric

> valve in tact?

>

> All of this aside, I think that this study is vital to getting

> insurers to cover DS without the " investigational crap " that they

give

> now. I also think that it is a great way for the world to find out

the

> long term benefits of DS. The more published data there is out

there

> the more likely that people will choose DS over RNY.

>

> That said, I couldn't do it not even for a lot of money. I love my

> steak and not to be able to enjoy a good steak for atleast a year

> would be akin to agony. Then again if you had told me pre-op that I

> would hate chocolate post-op I would have laughed you out of the

room.

>

> my rambling 2 cents.

> Tina

>

>

>

> > Hi all. I am new to this group. I may be offered the chance to

> > paticipate in a blind research study comparing the distal RNY to

the

> > DS. It would require that I agree to an open procedure, but also

> that

> > I would agree to having a card drawn during the procedure to

> > determine whether I would wake up with the RNY or the DS. I am

> > wondering what some of you think about this type of uncertainty.

Any

> > constructive comments are welcome. Thanks!

[Guest guest]

Blind Study

> I would agree to having a card drawn during the procedure to

> determine whether I would wake up with the RNY or the DS. I am

> wondering what some of you think about this type of uncertainty. Any

> constructive comments are welcome. Thanks!

Holy cow. Talk about Russian roulette! I wouldn't go with this b/c I don't

want a RNY. If I was ambivalent about it, then I'd go for it, but I'm not.

Good luck!

alyssa

[Guest guest]

RnY surgery: the blind leading the blind...

--S

--

[Guest guest]

Outrageous.>>>>

Agreed!

J

[Guest guest]

> Hi all. I am new to this group. I may be offered the chance to

> paticipate in a blind research study comparing the distal RNY to

the

> DS. It would require that I agree to an open procedure, but also

that

> I would agree to having a card drawn during the procedure to

> determine whether I would wake up with the RNY or the DS. I am

> wondering what some of you think about this type of uncertainty.

Any

> constructive comments are welcome. Thanks!

,

I'm sure you will get lots of responses on this one.

I'm sure you already have. I've been lurking on this

list and several others for quite awhile as well as

doing my own research. Best of luck to you in whatever

you decide for your own eventuality--but,[and here comes

my 2cents worth]I wouldn't draw a card, draw straws,flip

a coin, call a psychic hotline or a tarot card reader,

consult my daily horoscope, read tea-leaves or gaze into

a crystal ball in order to make this life transforming

and/or altering decision. My best advice would be to

research in the way of fact-finding and reading actual

accounts of peoples experiences that have gone before-

the good ,the bad ,and the ugly in order to determine

what you individually can live with long term to regain

the quality of life that you want and deserve.

Now, on to read everyone else's responses to this!!!

Jill Koepke

BMI 45-289lbs.

1st consult w/Dr.Herron Oct.24th

[Guest guest]

> Hi all. I am new to this group. I may be offered the chance to

> paticipate in a blind research study comparing the distal RNY to

the

> DS. It would require that I agree to an open procedure, but also

that

> I would agree to having a card drawn during the procedure to

> determine whether I would wake up with the RNY or the DS. I am

> wondering what some of you think about this type of uncertainty.

Any

> constructive comments are welcome. Thanks!

,

I'm sure you will get lots of responses on this one.

I'm sure you already have. I've been lurking on this

list and several others for quite awhile as well as

doing my own research. Best of luck to you in whatever

you decide for your own eventuality--but,[and here comes

my 2cents worth]I wouldn't draw a card, draw straws,flip

a coin, call a psychic hotline or a tarot card reader,

consult my daily horoscope, read tea-leaves or gaze into

a crystal ball in order to make this life transforming

and/or altering decision. My best advice would be to

research in the way of fact-finding and reading actual

accounts of peoples experiences that have gone before-

the good ,the bad ,and the ugly in order to determine

what you individually can live with long term to regain

the quality of life that you want and deserve.

Now, on to read everyone else's responses to this!!!

Jill Koepke

BMI 45-289lbs.

1st consult w/Dr.Herron Oct.24th

[Guest guest]

I agree, Meli. Blind studies usually imply the use of placebos. In

other words, some people are treated for X and others aren't.

There were blind studies as a part of the FDA approval for

Meridia, Xenical, etc. to compare weight loss in one group vs. the

other group. I think someone either misunderstood or

misrepresented the study. This kind of " study " sounds like, if

true, some surgeon's desperate attempt to get tenure at a

research hospital or a poorly informed and researched grant

proposal.

Informed consent, ethics and legalities aside, I don't even see

the need for such a " study " . If someone wants to compare RnY

and DS, they can certainly send questionnaires out to the

thousands of patients already being tracked by the surgeons.

Dr. Rabkin compared RnY and DS in his own practice for a

published paper.

-maria

> Tina, You are much less suspicious than I... I dont think this is

> legitimate. Either this person is being pranked or all of us are.

I

> cant imagine that such a thing would be either ethical or legal.

> JMHO,Meli

>

[Guest guest]

Before I new about the DS I would have had the RNY, but after

learning about the DS I would not have the DS even if they paid me to

get it.

[Guest guest]

Ditto. What Aviva said.

The more I think about this, the more I think that this sounds like

some backwoods, underground type of medical experiment.

<shudder>

-maria

> There is something exceedingly strange and extremely

> unsettling about this. If you cannot independently and

> securely establish the credentials of whoever is offering this

> - I would run - not walk -in the direction of the nearest reputable

> physician and hospital. This is your life we're talking about.

[Guest guest]

Ditto. What Aviva said.

The more I think about this, the more I think that this sounds like

some backwoods, underground type of medical experiment.

<shudder>

-maria

> There is something exceedingly strange and extremely

> unsettling about this. If you cannot independently and

> securely establish the credentials of whoever is offering this

> - I would run - not walk -in the direction of the nearest reputable

> physician and hospital. This is your life we're talking about.

[Guest guest]

Yes, and not only does look fantastic, but look at her

skin!!! No hanging or wobbling...If she wasnt such a sweetheart I

would have to hate her!! Some folks have all the good genetics!

Meli

-- In duodenalswitch@y..., " Pam Bilyeu " <psbilyeu@y...> wrote:

> Holy SOcks!! I went to the link at the bottom of your

em. WOW!!

> You look fantastic!! Congratulations on the loss!! Size 12 looks

sweet on

> you!!

>

> Pammi

>

> Re: Re: Blind Study

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