Trans-oral anterior fundoplication: 5-year follow-up of pilot study

Aviel Roy-Shapira, Amol Bapaye, Suhas Date, Rajendra Pujari, Shivangi Dorwat, Aviel Roy-Shapira, Amol Bapaye, Suhas Date, Rajendra Pujari, Shivangi Dorwat

Abstract

Background: This is a report of an IRB-approved pilot study of 13 patients who received a trans-oral 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 comorbidity. Under general anesthesia, a flexible stapler was passed trans-orally into the stomach and placed two or three quintuplets of titanium staples approximately 3 cm above the gastroesophageal junction. The stapler contains an ultrasonic range finder, video camera, and illuminator.

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 5 years to collect GERD-HRQL scores, PPI use, satisfaction with the procedure, and willingness to have the procedure again.

Results: At 6 weeks, mean total acid exposure was significantly reduced, and 12/13 patients reduced GERD-HRQL scores by ≥50%. Twelve of 13 patients had stopped daily GERD medications, and nine of 13 had stopped all GERD medications. Each year, 11 of the 13 patients could be reached with all 13 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 1 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 second year.

Keywords: Clinical papers/trials/research; G-I 

Figures

Fig. 1
Fig. 1
Trans-oral stapling procedure: Stapler positioned under direct visualization (left), Stapling placed ~3 cm cephalad to GEJ (middle); each stapling delivers a five titanium staples (right). Schematics courtesy of Medigus, Ltd
Fig. 2
Fig. 2
Retrograde view of trans-oral stapled anterior fundoplication (left) and laparoscopic fundoplication (right). Photograph on right courtesy of Prof. D. Watson, Adelaide, Australia

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