V.V. Grubnik, Prof, Avv. Malynovskyi. Odessa national medical university
Introduction. According to our classification, we qualify «large» hiatal hernias as those with with hiatal surface area (HSA) of 10 – 20 ?m2. The recurrence rate following primary repair of such hernias reach 40 %. Mesh repair may minimize recurrence, but can cause complications. Thus, the optimal technique of repair of large hernias remains questionable. Therefore, primary crural repair, and sub-lay prosthetic repair using partially absorbable lightweight mesh Ultrapro (Ethicon), should be compared in randomized controlled trial.
The aim of this study was to assess early results of this trial.
Methods and procedures. The double-blind phase III “LARGE” trial (? NCT01408108, Clinicaltrials.gov) was started on January 2013, and patient recruitment was finished on June 2014. Main inclusion criteria: 1) types I, II and III hiatal hernias, including complicated by GERD, 2) HSA of 10 – 20 ?m2 (confirmed intraoperatively). Main exclusion criteria: 1) ASA > II, 2) age < 20 and > 80 years, 3) BMI < 16 and > 39 kg/m2, 4) oesophageal motility disorders, 5) oesophagal peptic strictures, 6) shortened oesophagus (confirmed intraoperatively), 7) Barrett‘s oesophagus. Total involvement was 100 patients; 6 patients did not mach eligibility criteria, 2 patients refused of participation; 92 were randomized in 2 arms: I arm – primary repair (46 patients), II arm – lightweight mesh repair (46 patients). Primary end points of the trial are rates of anatomic recurrences, reflux recurrences, and repair-related complications. Time frame of the trial is 2 years.
Results. No statistcally significant differences were revealed between arms by demographic data (age, gender, BMI, ASA), preoperative findings (symptoms by visual analogue scores, GERD-HRQL scores, degree of reflux-oesophagitis, oesophageal motility, DeMeester scores) and intraoperative findings (HSA, Hill’s types of hernias). Sighnificant difference between arms was revealed in operative time (60,6 ± 9,2 (50 – 85) versus 79,0 ± 11,9 (50 – 110), p < 0,0001). All postoperative complications were Clavien-Dindo class I, there were no significant differences in their rates between arms (6,7 % versus 4,3 %, p = 0,5), and they were not related to compared techniques. To date, no signs of early recurrence or repair-related complications were obtained in both arms.
Conclusions. As arms are statistically comparable, and no recurrence or repair-related complications were revealed to date, patient recruiment may be finished and study should be continued for assessment of further results in certain terms.