Results of a prospective, uncontrolled, single-arm study of 1,351 patients with hiatal hernia operated on exclusively with DeltaMesh hiatal reconstruction over a 10-year period
Background: Surgical gastroesophageal reflux disease (GERD) therapy is conceptually based on the hypothesis of a deficient lower oesophageal sphincter (LES). Consequently, the focus is on a variety of internal or external oesophageal constrictions, with Nissen and Toupet surgery considered the gold standard. However, clinical outcomes still show wide variations in terms of recurrence and complications and, in particular, there are still unresolved fundamental inconsistencies regarding the function and actual existence of the LES. In this work, a new surgical procedure, laparoscopic oesophagohiatal DeltaMesh enhancement (LOEHDE), was used, based on the emerging pathophysiological suggestion that reflux is instead significantly controlled by a complex cardioesophageal pumping system that decisively depends on the intact hiatal architecture. Accordingly, the surgical focus was solely on the anatomical correct reconstruction of the oesophagohiatal unit without any fundoplication or other conventional anti-reflux measures. Methods: In a 10-year prospective clinical single arm cohort study from January 2007 to December 2016, all consecutively admitted patients with symptomatic hiatal hernia who met the inclusion criteria underwent the DeltaMesh enhanced oesophagohiatal reconstruction. Patients follow-up was recorded by standardised questionnaires given preoperatively on admission (T0; 43 questions), postoperatively at 1 year (T1; 24 questions) and 5 years (T5; 22 questions). There was no randomisation and no control group, as all patients refused any other form of surgery, especially fundoplication. Results: A total of 1,351 patients were included and operated on. The follow-up rate was 96% at T0 (1,297/1,351), 68.6% at T1 (927/1,351), and 14.8% at T5 (200/1,351). The Visick score, symptom score, and patient rating significantly improved postoperatively at T1 and T5 (P<0.0001) compared with the situation under medical treatment at T0 in all symptom categories: A (reflux, heartburn); B (hoarseness, coughing); C (palpitation, dyspnoea); and D (belching, nausea). Recurrence was observed in 91 of the 1,351 (6.7%) patients. DeltaMesh penetration was observed in the oesophagus (n=2) and stomach (n=3). Mortality (n=1) was 0.07%. Conclusions: Anatomical reconstruction of the oesophagohiatal unit alone resulted in significant restoration of oesophageal function without fundoplication, confirming the new pathophysiological approach. LOEHDE proved to be a safe, efficient, and standardisable procedure for symptomatic hiatal hernia.
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