V.v. Grubnik, A.v. Malynovskyi. Odessa national medical university, Ukraine
INTRODUCTION: We define large hiatal hernias as those with hiatal surface area (HSA) of 10 – 20 cm2. There is still no consensus regarding the best repair technique for large hiatal hernias: primary crural repair, or lightweight mesh repair. Therefore, a prospective randomized trial (“LARGE” trial, No. NCT01408108) was started in 2013. The aim of this study is to assess long-term results of the trial.
METHODS AND PROCEDURES: Ninety two patients have been allocated to 2 arms: arm I – primary crural repair (46 patients); arm II – lightweight partially absorbable mesh repair (Ultrapro, Ethicon) with fixation of prosthesis posteriorly to the approximated crura, “two-layer technique” (46 patients). Nissen fundoplication have been performed in every patient. Main inclusion criteria: types I, II and III hiatal hernias; HSA of 10 – 20 cm2. Main exclusion criteria: ASA > II, age < 20 and > 80 years, BMI < 16 and > 39 kg/m2, oesophageal motility disorders, oesophageal peptic strictures, shortened oesophagus. Primary outcome measures: rates of anatomic recurrences and repair-related complications. Methods of assessment: symptom and quality of life (GERD-HRQL) questionnaires, barium series, endoscopy, and 24h pH study. Eighty nine patients have been assessed with a mean follow-up period of 24.4 ± 0.72 months (range, 24 – 27).
RESULTS: Patients demographics (age, gender, ASA, BMI, hernia types) and preoperative data (HSA, symptom scores, quality of life score, grades of oesopagitis, DeMeester score) have not differed between arms. Anatomical recurrences have been revealed in 7 patients (15.5 %) from arm I (5 symptomatic, 2 asymptomatic), and in only 1 patient (2.3 %) from arm II (asymptomatic) (p = 0.0313). Moderate persisting dysphagia (without evidence of oesophageal stricture or mesh erosion) have been observed in 1 patient (2.2 %) from arm I, and in 2 patients (4.5 %) from arm II (p = 0.4915). Other subjective and objective data also favoured arm II, i.e. mesh repair.
CONCLUSIONS: Two-years long-term results of prospective randomized trial showed superiority of lightweight partially absorbable mesh repair over primary repair in prevention of recurrence, without increase in complications. We advice to use our original “two-layer technique” as a procedure of choice for large hiatal hernias.
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 77330
Program Number: S147
Presentation Session: Foregut 3
Presentation Type: Podium