Gastric plication is a restrictive operation. "In our experience so far with the 50-plus patients that we’ve done, their satiety is very good. Patients are achieving rapid weight loss and are very satisfied with their early outcomes. Our clinical experience with this procedure so far has been promising," he said.
It’s unknown what, if any, nutritional consequences may be associated with the procedure. "Even with sleeve gastrectomy, we don’t have a lot of very good data on the long-term nutritional consequences of the sleeve. Presumably, there will be some micronutrient deficiencies with gastric plication because the overall dietary intake is lower," Dr. Brethauer noted.
"We’re treating this – from a nutritional standpoint – similarly to what we do with the sleeve ... multivitamins with iron and extra supplementation as needed, based on our follow-up labs. ... There’s no good data to say what effect this has on micronutrients at this point, so we’re being conservative in our approach."
Nausea, a common side effect, typically resolves within several days after surgery, according to Dr. Brethauer.
Because gastric plication is an investigational procedure, patients currently must pay for it out of pocket. Patients increasingly are interested in this approach, but much more data with favorable long-term outcomes will be needed before insurers will agree to cover it, according to Dr. Brethauer.
Thus far, most patients who have undergone this investigational procedure have had a body mass index of 35-50 kg/m2. "We’re trying not to go to the very high BMIs at this point until we have more experience," Dr. Brethauer said.
GCP is not yet an outpatient procedure. "We’ve kept patients for 1 or 2 nights in the hospital just because we are still learning about the procedure. But I think that as we get more experience with it, carefully selected patients may be able to go home [on] the same day as the operation."
The study was funded by Ethicon Endo-Surgery, and the sponsor paid for all the preoperative testing and consultations, surgery, treatment of any potential complications, as well as all the follow-up testing and visits after surgery during the study period. Dr. Brethauer is a consultant, speaker, and advisory board member for Ethicon Endo-Surgery, a speaker for Covidien, and a consultant for Apollo Endosurgery.