More Information on The RESTORe Procedure
(deactivated member)
on 2/4/08 12:02 pm
on 2/4/08 12:02 pm
There has been a lot of speculation surrounding why the RESTORe study was suddenly ended. I finally was able to track down my trial coordinator Sidney and got some additional feedback from her about it.
As already discussed in previous posts it is in fact because the company developed a more efficient tool. Previously only one stitch could be made at one time, then the device needed to be removed and reloaded before another stitch could be made thus requiring more time to perform the procedure and longer anesthesia time. According to Sidney, the company has received enough data to know that they do want to continue with the research, but want to put the rest of the money into marketing the new device. This newer device can make more stitches at one time without removing the tool to reload.
I asked her a bunch of questions about how people are doing overall...are the stitches holding etc. I was especially concerned because several days ago someone posted about being in the lead in phase and at her 6 week appt she was told that none of the stitches held up.
Now Sidney can only speak for the patients who had the procedure done at the Cleveland Clinic, but she says no one there has lost all stitches. On a few of the patients, some stitches have come out (mostly due to noncompliance with post op diet), but she said that many times some scar tissue remains keeping that stoma from opening wide up again. She also said that everyone who has actually had it done has lost weight with the exception of 1 person who traveled a lot and had a hard time making good choices because of it. She also mentioned that there has been some discouragement among patients because they went into the study thinking they would lose their weight as quickly as with their initial RNY and of course that doesn't happen.
After I talked to her I felt GREAT! If the company was receiving poor feedback from data of those already in the study then I would imagine they wouldn't bother to continue pouring money into it at all. I really hope this device is made available for the hundreds (or thousands) of others who need their stomas reduced. I'm still going strong here! Losing slower but steady and very complaint with my eating habits and more determined than ever to get to my goal.
Feel free to message me or post here if you have any questions!
I gotta admit I was starting to get concerned after I saw that post about all the stitches coming out. I have very little communication with my study coordinator so I'm grateful for the information you're providing. I think I'll email my study coordinator and ask some of the same questions you've asked yours and see what she says.
Betsy
Lap RNY 5/7/03
I lost 50+ pounds of regained weight with hCG drops.