Outcomes of second-generation transoral incisionless fundoplication in a Mediterranean cohort: a retrospective study of the first Turkish experience with typical and extraesophageal gastroesophageal reflux disease symptoms.

Abstract

Background/aims: Transoral incisionless fundoplication (TIF 2.0) has demonstrated efficacy in Western populations; however, data from Mediterranean cohorts are limited. This prospective observational study with retrospective analysis aimed to evaluate the safety and short-term efficacy of TIF 2.0 in Turkish patients with gastroesophageal reflux disease (GERD), using culturally validated questionnaires for both typical and extraesophageal symptoms.

Methods: Twenty-eight patients with chronic GERD underwent TIF 2.0 between July 2023 and March 2025 at a single Turkish tertiary center. Patient data were prospectively collected at baseline and six months after the procedure. The primary outcome was composite clinical success at 6 months, defined as improvement in at least one subjective measure (>50% improvement in gastroesophageal reflux disease health-related quality of life (GERD-HRQL) or reflux symptom index (RSI) total scores) and at least one of the following: discontinuation of proton pump inhibitor (PPI) use or endoscopic healing of esophagitis.

Results: All procedures were technically successful, with no serious adverse events. Mean GERD-HRQL scores decreased significantly from 27.0±10.1 to 5.0±3.9 (p<0.001), while RSI scores decreased from 16.1±9.1 to 3.9±5.1 (p<0.001). At six months, 85.7% of the patients discontinued PPI use, with the remaining patients requiring occasional use, and patient satisfaction improved from 0% to 86% (p<0.001). All patients with baseline esophagitis (n=24) exhibited complete endoscopic healing.

Conclusions: As a pilot study, these preliminary findings support TIF 2.0 as a viable treatment option and provide the foundation for future multicenter trials.