Andreas M Schneider, MD, Ralph Aye, MD, Alex Farivar, MD, Eric Vallieres, MD, FRCSC, Candice Wilshire, MD, Brian Louie, MD. Swedish Medical Center
Introduction: In a prospective randomized controlled multi-institution trial (RCT) comparing the Nissen (LNF) and Hill (LHR) repairs we were able to show that the two repairs were equivalent in the surgical treatment of uncomplicated gastroesophageal reflux disease (GERD). However recurrence patterns differed, reflecting the inherent weakness in each repair. We therefore combined critical features of each repair to create a laparoscopic Nissen-Hill Hybrid operation (HYB). Its safety and feasibility have been studied in a separate trial. This study aims to evaluate clinical and objective outcomes of the HYB in comparison to the two established repairs.
Methods: 51 consecutive patients with uncomplicated GERD (hiatal hernia (HH) <5cm, normal esophageal motility, <2cm Barrett’s metaplasia) underwent HYB in a prospective trial between 6/2011 and 12/2013. Preoperative and postoperative evaluation was standardized in accordance with the RCT and included 3 quality of life metrics (QOLRAD, GERD-HRQL, Dysphagia) which were administered preoperatively and postoperatively short-term (ST) at 6 weeks and mid-term (MT) at 6-12 months. Endoscopy, manometry, pH testing and barium swallow were obtained preoperatively and at 6-12 months. Results were then compared retrospectively with the two cohorts from our prior RCT, which included 46 LNF and 56 LHR patients.
Results: Demographic features such as age, BMI, ASA, length of stay, follow up, as well as the pre-operative clinical HH size, lower esophageal residual pressures (rLESP), esophageal motility, pH, and DeMeester (DM) score were comparable between the 3 groups.
51 patients underwent HYB repair; 44 patients were available for MT analysis. Mean follow up for HYB, LNF and LHR was 21.1, 15.3 and 18.3 months. The mortality rate was 0%. Major complications included: intraoperative gastrotomy (HYB=1,LNF=2, LHR=1), bleeding >200cc (HYB=0, LNF=1, LHR=2) and dilatation for dysphagia (HYB=3, LNF=1, LHR=4). Postoperative QOL metrics QOLRAD and GERD-HRQL were significantly improved and equivalent between groups. MT dysphagia score was significantly better for HYB (39.1) compared to LNF (34.0) but not the LHR (36.5) group (p= 0.055).
Objective outcomes: pH and DeMeester scores were significantly improved and equivalent between groups. LESP was significantly higher in LNF (26.2) compared to the LHR (19.7) but remained comparable to the HYB (26.4); rLESP, however, was statistically higher in the HYB group (16.7) LNF (8.2) and LHR (10.0) (p = 0.014). Resumption of PPI’s was comparable between HYB (13.6), LNF (5.26%) and LHR (9.62%) (Yates p value = 0.65).
There were two reoperations each in the LNF and LHR groups for failure and recurrent reflux. In the HYB group radiographic studies showed 2 herniations >2cm on UGI, with one patient having resumed PPI’s despite negative pH testing and the other with mild symptoms not requiring intervention. There were no re-operations in the HYB group
Conclusion: Our investigation shows that at mid-term follow up, the HYB repair results in equivalent clinical and objective outcomes compared to the LNF and LHR for uncomplicated GERD, though the recurrence rate may be lower. Dysphagia was significantly better than LNF, though rLESP was higher. Long-term follow up is necessary.