what is the difference RESTORe /Stomafx

mipo1
on 1/29/08 12:05 am - Lowell, MA
does anyone know the difference between these two procedures ?   I am in the RESTORe trial for March but have been hearing that the Stomaphyx trial had been stopped due to suture failure.  There has to be a difference that allows one trial to continue and the other to be stopped prematurely.  Anyone out there know? 
(deactivated member)
on 1/29/08 1:35 am
Mipo- Stomaphyx is not in trial phases.  People pretty much have to pay for this procedure out of pocket as most insurers do not cover it.   In stomaphyx the pouch is sutured tighter.   As far as the stoma being tightened, I don't know.  Some people claim it is tightened, some say it isn't.  In RESTORe, only the stoma is sutured.  They don't do anything with the pouch.  RESTORe is currently in it's trial phase and if you qualify you do not have to pay out of pocket (as long as your insurance covers the initial EGD).  Also, you may or may not get the procedure.  1/3 of the participants get the "sham"  (I'm sure you already know this).   A few threads below this one is where you probably saw that RESTORe was being stopped due to suture failure.  This in fact is a rumor.  I have been in contact with my research nurse yesterday and today and she says that all of these rumors are news to her.  As far as she knows they are still recruiting in Cleveland (of course that could change at any time).  Maybe some of the other locations have reached their quota of participants because there is a cap on how many people are allowed to participate in the trial.  Cleveland is allowed 44 participants.   I hope I'm not in the minority, but I am very pleased with my procedure.  Nobody has confirmed that I actually had it done (and they won't until my 6 month appt).  I feel definite restriction and I feel like my tool has been fixed.  I look forward to hearing about your experience when you have it done in March!    
Betsy C.
on 1/29/08 3:27 am - Efland, NC
I think that's the nexus of the "rumor".  Only so many participants are alloted for enrollment at each site.  And certain sites may have already reached their allottment, thus closing enrollment.  BTW, I will haven't heard from the study coordinator with my date.  She emailed me yesterday saying she would call me today with a date.  I hope you're not in the minority either.  But I tend to think those for whom it hasn't worked  (or they aren't working it properly) are in the minority. 

Lap RNY 5/7/03
I lost 50+ pounds of regained weight with hCG drops.

mipo1
on 1/29/08 3:18 am - Lowell, MA
Thanks so much for replying.  I am scheduled for 3/4 for the procedure. My pouch is fine but the stoma has expanded  to 40mm.  The trial coordinator said it's the largest they have seen so far. My RNY was in 1999 and I did great until a few years ago now its as though I never had the surgery. I am really hoping I have the true procedure as there will be no doubt involved if I don't, at any rate I will have the procedure at the end of the trial in July 
Betsy C.
on 1/31/08 4:10 am - Efland, NC
Congratulations on your upcoming RESTORe procedure.  You'll be right after me - mine is 2/28.  One question for you about your post: You said you would get the procedure at the end of the trial in July.  I thought we had to wait 6 months from the date of procedure to find out if we actually had it or not, and at that time we would be offered the actual procedure.  Were you told differently? Betsy

Lap RNY 5/7/03
I lost 50+ pounds of regained weight with hCG drops.

mipo1
on 2/1/08 6:02 am - Lowell, MA
Yes I misspoke (misprinted?) it is to be 6 months post procedure.  I have no idea why I was thinking of July 
Betsy C.
on 2/1/08 9:24 pm - Efland, NC
That makes more sense. BTW, did you know that there is a Yahoo Group for RESTORe participants?  Go to http://health.groups.yahoo.com/group/restore_trial/join". Hope you will join us. Betsy

Lap RNY 5/7/03
I lost 50+ pounds of regained weight with hCG drops.

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