{
  "abstract": "Introduction Concomitant hiatal hernia repair and transoral incisionless fundoplication (cTIF) has emerged as a viable combination therapy for patients with gastro-oesophageal reflux disease (GORD) through innovative collaboration between foregut surgeons and interventional endoscopists. The procedure enables a consistent 270–300° omega-shaped valve in patients with pathological reflux and hiatal hernias (HH) > 2 cm, who would otherwise be unsuitable for TIF2.0 alone. It 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).Methods 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 GERD since 2021 were eligible for inclusion. Patients underwent a laparoscopic hiatal hernia repair immediately followed by same-session TIF in theatre. 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 adverse events (AGREE classification). Within-patient changes from baseline to 6- and 12-months were assessed using paired t-tests.Results 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, using regular anti-acid medication, and had a median HH size of 3 cm (IQR 2-3; range 1-7). Baseline acid exposure time was 9.1% (IQR 7.1-14.2), and median total reflux episodes were 74.5 (IQR 56-107). Mean baseline GERD-HRQL score was 34.8 (SD 12.4). The procedure was technically successful in all cases, with a mean procedure time of 84.3 minutes (SD 28.5; range 45-155), median of 2 crural sutures (IQR 2), 14 plication pairs (IQR 10-14), and 2-day inpatient stay (IQR 1-2). Thirteen adverse events occurred, predominantly AGREE grade I (n=9). Higher-grade events included hospital-acquired pneumonia (n=2, AGREE II), pyloric botulinum toxin injection for gastroparesis symptoms (n=1, AGREE IIIa), and one suspected leak requiring salvage Nissen fundoplication (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.Conclusions This European registry demonstrates that cTIF is safe and associated with sustained improvements in reflux-related quality of life and reduced acid-suppressive therapy use to 12 months.",
  "authors": [
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom",
        "University College London, London, United Kingdom"
      ],
      "name": "Benjamin Norton"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom",
        "University College London, London, United Kingdom"
      ],
      "name": "Andrea Telese"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Sundas Hasan"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Alana Stevens"
    },
    {
      "affiliations": [
        "Gastroenterology Service Intesto, Bern, Switzerland"
      ],
      "name": "Anne-Sophie Jasawant"
    },
    {
      "affiliations": [
        "University of Bern, Bern, Switzerland"
      ],
      "name": "Henrik Weber"
    },
    {
      "affiliations": [
        "Ospedale Isola Tiberina Gemelli Isola, Rome, Italy"
      ],
      "name": "Milutin Bulajic"
    },
    {
      "affiliations": [
        "Ospedale Isola Tiberina Gemelli Isola, Rome, Italy"
      ],
      "name": "Salvatore F Vadalà di Prampero"
    },
    {
      "affiliations": [
        "Teknon Medical Center, Barcelona, Spain"
      ],
      "name": "Rocío Temiño"
    },
    {
      "affiliations": [
        "Teknon Medical Center, Barcelona, Spain"
      ],
      "name": "Román Turró"
    },
    {
      "affiliations": [
        "Universitätsklinik für Allgemeinchirurgie, Vienna, Austria",
        "Klinische Abteilung für Viszeralchirurgie, Vienna, Austria"
      ],
      "name": "Sebastian Schoppmann"
    },
    {
      "affiliations": [
        "Memorial Bahçelievler Hastanesi, İstanbul, Turkey"
      ],
      "name": "Salih Boğa"
    },
    {
      "affiliations": [
        "University Clinical Center of Serbia, Belgrade, Serbia"
      ],
      "name": "Ognjan M Skrobic"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "David Monk"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Sacheen Kumar"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Borzoueh Mohammadi"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Muntzer Mughal"
    },
    {
      "affiliations": [
        "Department of Gastroenterology, Hôpital Fribourgeois, Bern, Switzerland"
      ],
      "name": "Dominic Staudenmann"
    },
    {
      "affiliations": [
        "Cleveland Clinic London, London, United Kingdom"
      ],
      "name": "Rehan Haidry"
    },
    {
      "affiliations": [
        "University Clinical Center of Serbia, Belgrade, Serbia"
      ],
      "name": "Simic Aleksandar"
    }
  ],
  "title": "P5 Outcomes of concomitant hiatal hernia repair and transoral incisionless fundoplication for gastro-oesophageal reflux disease: the EURO-TIF registry",
  "uid": "3388324c-924e-5a4d-823d-f045c638615d"
}