Interdisciplinary collaboration between foregut surgeons and interventional endoscopists is paving the way for the future of benign GI disease. Concomitant hiatal hernia repair and transoral incisionless fundoplication (cTIF) is one such innovation that has emerged as a viable combination therapy for patients with gastroesophageal reflux disease (GERD).  cTIF enables a consistent 270–300º omega-shaped valve in patients with pathological reflux and hiatal hernias (HH) > 2 cm, who would otherwise be unsuitable for TIF2.0 alone. cTIF is hypothesised to offer effective reflux control with lower morbidity than traditional Nissen fundoplication. We report one of the largest datasets outside North American on the safety and efficacy of cTIF conducted within the European TIF registry (EURO-TIF).

A prospective, multi-centre registry conducted across seven European centres and registered at Cleveland Clinic London (CCL-2021-TIF). All prospectively collected data among patients undergoing cTIF for the management of gastroesophageal reflux disease (GERD) since 2021 were eligible for inclusion. Patients underwent a laparoscopic hiatal hernia repair immediately followed by same-session TIF in theatre. The primary outcomes were change in reflux-specific quality of life questionnaires (GERD-HRQL and RSI) and acid suppression use from baseline to 12-months follow-up. Secondary outcomes included procedural outcomes and adverse events according to the AGREE classification. Within-patient changes from baseline to 6- and 12-months were assessed using paired t-tests, while insufficient paired observations were analysed descriptively.

In total, 62 patients underwent cTIF with a mean age of 49.9 years (SD 13.9), and 38.7% (n=24) were female. All patients were naïve to previous mechanical therapy, were using regular anti-acid medication, and had a median Charlson Comorbidity Index of 1 (IQR 0-1). The median HH size was 3 cm (IQR 2-3; range 1-7), baseline acid exposure time (AET) was 9.1% (IQR 7.1-14.2), and median total reflux episodes were 74.5 (IQR 56-107). Mean baseline GERD-HRQL and RSI scores were 34.8 (SD 12.4) and 14.8 (SD 9.3), respectively, and 98.3% (n=57) were dissatisfied with current treatment. The procedure was technically successful in all cases, with a mean procedure time of 84.3 minutes (SD 28.5; range 45-155), a median of 2 crural sutures (IQR 2), 14 plication pairs (IQR 10-14), and an inpatient stay of 2 days (IQR 1-2). Thirteen adverse events occurred; the majority AGREE grade I (n=9). Two patients developed hospital-acquired pneumonia (AGREE II), one underwent pyloric botox injection for gastroparesis symptoms (AGREE IIIa), and one developed a suspected leak requiring salvage Nissen fundoplication three days post-cTIF (AGREE IIIb). At 6- and 12-months, follow-up completion was 63% (34/54) and 38% (15/45), respectively. The proportion of patients no longer requiring anti-acid therapy at 6- and 12-months was 68.6% and 70.6%. Over the same period, mean GERD-HRQL scores were 7.1 (SD 6.9; n=34) and 6.8 (SD 5.1; n=15), corresponding to mean within-patient reductions of -30.3 (SD 13.2; p<0.001) and -32.8 (SD 13.5; p<0.001), respectively, and mean RSI scores of 3.1 (SD 4.0; n=17) and 4.7 (SD 4.5; n=7). One patient required an additional procedure (anti-reflux mucosal ablation) for worsening symptoms without evidence of recurrent HH.

We present the first European outcomes on patients undergoing cTIF demonstrating the combined procedure appears safe, feasible, and enables sustained symptom improvement and acid-acid therapy discontinuation over 12-months.