Trans-oral Anterior Fundoplication – Five Year Follow-up of Pilot Study

Roy-Shapira A, Bapaye A, Suhas D, Pujari R, Shivangi D.
Accepted for publication in Surgical Endoscopy.

Abstract

Background:
This is a report of an IRB approved pilot study of 13 patients who received a transoral anterior partial fundoplication for the treatment of GERD using an ultrasound guided, flexible surgical stapler. All patients had a history of PPI use, objective evidence of GERD, and no significant co-morbidity. Under general anesthesia, a flexible stapler was passed transorally to the stomach and placed 2 or 3 quintuplets of titanium staples approximately 3 cm above the gastroesophageal junction. The stapler contains an ultrasonic range finder, video camera and
illumination.

Methods: Primary follow-up at 6 weeks included pH metrics, GERD-HRQL scores and PPI use. The protocol allowed annual telephone interviews for the following five years to collect GERDHRQL scores, PPI use, satisfaction with the procedure, and willingness to have the procedure again.

Results: At six weeks, mean total acid exposure was significantly reduced, and 12/13 patients reduced GERD HRQL scores by ≥50%. 12 of 13 patients had stopped daily GERD medications, and 9/13 had stopped all GERD medications. Each year, 11 of the 13 patients could be reached
with all thirteen patients having at least 4 year follow-up. Throughout the follow up period, GERD-HRQL scores were normal (<10) in all but one patient. All patients would agree to do the procedure again. The median satisfaction score is 8 (range 6-10) on a scale of 1-10. None
reported dysphagia. At one year, 54% of respondents (6/11) had eliminated PPI use, with another 27% (3/11) taking a reduced dose. Combining respondents at 4 and 5 years to account for all patients, 54% (7/13) had eliminated and another 23% (3/13) reduced PPI use ≥50%.

Conclusion: At 5 years, the procedure remained effective as demonstrated by the improved quality of life and changes in PPI use. The results remained stable after the 2nd year