A study has found that trans-oral fundoplication surgery is an effective treatment for patients with gastro-oesophageal reflux disease, especially for patients with persistent regurgitation despite proton pump inhibitor therapy, reports Science Daily.
"Despite therapy, patients with GERD often suffer from troublesome regurgitation, which impairs their quality of life," said lead study author Dr John G Hunter, from Oregon Health & Science University "This study offers evidence that tran-soral fundoplication is effective in eliminating troublesome GERD symptoms, especially regurgitation, with a low failure rate and good safety profile for six months."
Researchers performed a prospective, sham-controlled trial to determine if trans-oral fundoplication provided GERD patients with better relief of troublesome regurgitation, or the sensation of acid backing up into a patient's throat or mouth, when compared to PPI therapy. The researchers randomly assigned 129 patients with troublesome regurgitation despite daily PPI use to trans-oral fundoplication using the EsophyX-2 device and six months of placebo, or a sham surgery and six months of once or twice daily omeprazole. Patients were then evaluated for six months.
The primary endpoint in this study, elimination of troublesome regurgitation, was achieved in a greater proportion of patients treated with trans-oral fundoplication than with omeprazole: 67% versus 45%. Further, a larger proportion of controls demonstrated no response at three months (36%) than patients who underwent trans-oral fundoplication (11%). Subjects from both groups who completed the protocol had similar reductions in GERD symptom scores. Severe complications were rare.
This study provides evidence of transoral fundoplication's efficacy, and will likely lead to more widespread use of the procedure in clinical practice.Full Science Daily report Gastroenterology abstract