EndoGastric Solutions announced the publication of data from the first-ever blinded, randomized clinical study of the Transoral Incisionless Fundoplication procedure, in Gastroenterology, the official journal of the American Gastroenterological Association Institute.
For the sham-and placebo-controlled study, 87 patients were randomly assigned to the group that underwent the TIF procedure and then received an ongoing course of placebo medication. Additionally, 42 patients were randomized to undergo sham surgery and then continued to take optimized doses of proton pump inhibitor regiment.
After six months, of the TIF procedure patients, 67 percent reported elimination of troublesome regurgitation per Montreal consensus criteria; and 77 percent had healed their reflux esophagitis.
Of the sham surgery group, 45 percent reported elimination of troublesome regurgitation per Montreal consensus criteria.
"The data demonstrates that the TIF procedure is more effective than optimized PPI drugs at eliminating troublesome regurgitation in selected chronic GERD patients with hiatal hernia less than 2 cm," said John Hunter, MD, Mackenzie Professor and chairman of surgery at Oregon Health & Science University in Portland and co-principal investigator of the study.
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