BACKGROUND:Laparoscopic Hill repair (LHR) and laparoscopic Nissen fundoplication (LNF) are established surgical antireflux procedures but have never been compared in a prospective trial. This trial was designed to compare the effectiveness of LHR against the gold-standard LNF. METHODS:Patients with uncomplicated gastroesophageal reflux from two esophageal centers were randomly assigned and blinded from 2003 to 2007. Preoperative and postoperative evaluation included two quality of life metrics--Quality of Life in Reflux and Dyspepsia, and Dysphagia--as well as endoscopy, video esophogram, manometry, and pH testing. RESULTS: Of 121 patients who consented to the trial, 102 underwent surgery; 46 LNF and 56 LHR were performed, with a mean follow-up of 12 months. Postoperatively, the DeMeester score normalized for both repairs, with no difference between them (LNF 6.8, LHR 11.1, p=0.26). Postoperative medication use was 4%, and the groups were equivalent. Lower esophageal sphincter pressure increased significantly for LNF (14.93 to 24.10, p=0.001) but not for LHR (19.91 to 20.25, p=0.87). Quality of life scores improved significantly for both repairs (LNF 3.77 to 6.65; LHR 3.84 to 6.54, p<0.001), and postoperative results were equivalent (p=0.99). Dysphagia scores preoperative/postoperative were LNF 33.88 to 38.33 and LHR 35.44 to 38.72, and were equivalent postoperatively (p=0.94). Two LNF and two LHR required reoperation for failed repair. CONCLUSIONS: The LHR and the LNF both yield excellent and equivalent results for uncomplicated gastroesophageal reflux at 12 months. Their mechanisms of action may be different.
RCT Entities:
BACKGROUND: Laparoscopic Hill repair (LHR) and laparoscopic Nissen fundoplication (LNF) are established surgical antireflux procedures but have never been compared in a prospective trial. This trial was designed to compare the effectiveness of LHR against the gold-standard LNF. METHODS:Patients with uncomplicated gastroesophageal reflux from two esophageal centers were randomly assigned and blinded from 2003 to 2007. Preoperative and postoperative evaluation included two quality of life metrics--Quality of Life in Reflux and Dyspepsia, and Dysphagia--as well as endoscopy, video esophogram, manometry, and pH testing. RESULTS: Of 121 patients who consented to the trial, 102 underwent surgery; 46 LNF and 56 LHR were performed, with a mean follow-up of 12 months. Postoperatively, the DeMeester score normalized for both repairs, with no difference between them (LNF 6.8, LHR 11.1, p=0.26). Postoperative medication use was 4%, and the groups were equivalent. Lower esophageal sphincter pressure increased significantly for LNF (14.93 to 24.10, p=0.001) but not for LHR (19.91 to 20.25, p=0.87). Quality of life scores improved significantly for both repairs (LNF 3.77 to 6.65; LHR 3.84 to 6.54, p<0.001), and postoperative results were equivalent (p=0.99). Dysphagia scores preoperative/postoperative were LNF 33.88 to 38.33 and LHR 35.44 to 38.72, and were equivalent postoperatively (p=0.94). Two LNF and two LHR required reoperation for failed repair. CONCLUSIONS: The LHR and the LNF both yield excellent and equivalent results for uncomplicated gastroesophageal reflux at 12 months. Their mechanisms of action may be different.
Authors: Andrea Wirsching; Moustapha A El Lakis; Kamran Mohiuddin; Agostino Pozzi; Michal Hubka; Donald E Low Journal: J Gastrointest Surg Date: 2017-08-02 Impact factor: 3.452
Authors: Ralph W Aye; Alia P Qureshi; Candice L Wilshire; Alexander S Farivar; Eric Vallières; Brian E Louie Journal: Surg Endosc Date: 2015-06-12 Impact factor: 4.584
Authors: Andreas M Schneider; Ralph W Aye; Candice L Wilshire; Alexander S Farivar; Brian E Louie Journal: J Gastrointest Surg Date: 2016-11-03 Impact factor: 3.452