Short-term outcomes of laparoscopic hiatal hernia repair with consecutive transoral incisionless fundoplication (cTIF): a prospective multicenter cohort study

BACKGROUND: Transoral Incisionless Fundoplication (TIF 2.0) is an endoscopic anti-reflux procedure that recreates the gastroesophageal flap valve as a partial fundoplication and can be followed consecutively with a laparoscopic hiatal hernia repair (cTIF) for treatment of pathologic reflux. Studies reporting subjective and objective physiologic outcomes are limited. We report short term outcomes for symptom response, proton pump inhibitor (PPI) use, and esophageal acid exposure before and after cTIF. METHODS: Patients with BMI <35 kg/m 2, axial hiatal hernia < 5cm, confirmed GERD, and no prior anti-reflux intervention treated with cTIF were enrolled in an ongoing prospective multicenter registry. The primary endpoint was clinical success defined by patient-reported symptom improvement on validated questionnaires within 12 months (>50% decrease in GERD-HRQL score). Secondary endpoints included normalization of RSI, normalization of esophageal acid exposure time by pH testing or discontinued/rare PPI use, patient satisfaction. and adverse events. RESULTS: 188 patients (mean 3cm hiatal hernia) underwent cTIF at 8 sites with median length of stay 23 hours [IQR 16-25]. Complete clinical success was achieved in 92% of cases. After cTIF, patients reported symptom improvement in GERD-HRQL scores (90%) and normalized RSI score (84%). Most patients discontinued daily PPI use (84%). After cTIF, 84% had normal esophageal acid exposure time and 85% had a normal DeMeester score. Overall patient satisfaction improved from 6% to 75%. There were 3 cTIF-related serious adverse events (1.6%). CONCLUSION: cTIF is a safe and effective anti-reflux operative treatment option for selected patients with proven GERD.