Veeravich Jaruvongvanich, Reem Matar, Sneha Singh, David A. Katzka, Marcia I. Canto, Barham K. Abu Dayyeh

Transoral incisionless fundoplication (TIF) is a lesser invasive endoscopic procedure for gastroesophageal reflux disease (GERD) alternative tolaparoscopic Nissen fundoplication (LNF). Many patients with GERD require hiatal hernia (HH) repair. The US Food and Drug Administration expanded the indication of TIF for patients with hiatal hernia > 2 cm with concomitant HH repair. Recent studies demonstrated favorable outcomes of TIF with HH repair. Data comparing this modality with conventional LNF is lacking.

We therefore compared clinical outcomes and adverse events between TIF with HH repair and LNF with HH repair.

This was a multicenter retrospective comparative study of LNF with HH repair (3 centers) versus TIF with HH repair (3 centers) in patients with GERD and moderate hiatal hernia (2-5 cm) from 2001 to 2019. Patients who had open surgical approach, a follow-up of less than 6 months, and prior anti-reflux surgery were excluded. Early (<30 days) and late (30 days to 12 months) adverse events (not including dysphagia and bloating) were assessed using Clavien-Dindo classification, in which severe adverse events were defined as grade III-V. Symptoms (heartburn/regurgitation, bloating, and dysphagia) at 6 and 12 months were assessed using GERD-HRQL questionnaire in the TIF cohort and chart review in the LNF cohort.

A total of 125 patients with TIF and HH repair and 70 with LNF with HH repair (BMI and hernia size-matched, mean BMI 29.2±4.7 kg/m2, mean age 57.2±14.3 years) were compared. The length of hospital stay (TIF: 1 (interquartile range [IQR] 1-2) days vs. LNF: 2 (IQR 1-2) days), 30-day readmission (0 vs. 4.3%), early adverse events (0 vs. 18.6%), and early serious adverse events (0 vs. 4.3%) favored TIF (all P< 0.05) (Table 1). There were no late adverse events in both groups. The rate of discontinued or decreased proton pump inhibitor (PPI) use and the number of patients with no GERD and no PPI use were similar in both groups at 6 and 12 months (all P > 0.05). PPI non-users at baseline did not start PPI. A higher incidence of bloating (new or worse than baseline) was observed in the LNF group at 6 months (30.0% vs. 13.8%, P = 0.009) and a trend at 12 months (24.2% vs. 14.9%, P = 0.18). The incidence of dysphagia (new or worse than baseline) was similar in both groups. In those who had pre-and post treatment endoscopy within 6-12 months after procedure, the rate of improvement/resolution of esophagitis and recurrence of hiatal hernia were not different between the two groups (P > 0.05) (Table 2).

In this large retrospective case-match study TIF with HH repair was equivalent to LNF with HH repair for symptom control up to 12 months with a lower rate of adverse events, gas-bloat syndrome, and a shorter hospital stay. A randomized clinical trial is warranted to validate our findings.

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