title: Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation: Observational cohort study with propensity score analysis.
abstract: Only a minority of patients with gastro-esophageal reflux disease (GERD) are offered a surgical option. This is mostly due to the fear of potential side effects, the variable success rate, and the extreme alteration of gastric anatomy with the current gold standard, the laparoscopic Nissen fundoplication. It has been reported that laparoscopic Toupet fundoplication (LTF) and laparoscopic sphincter augmentation using a magnetic device (LINX) can treat reflux more physiologically and with a lower incidence of side-effects and reoperation rate. We present the first comparing quality of life in patients undergoing LTF versus LINX.Observational cohort study. Consecutive patients undergoing LTF or LINX over the same time period were compared by using the propensity score full matching method and generalized estimating equation. Criteria of exclusion were >3 cm hiatal hernia, grade C-D esophagitis, ineffective esophageal motility, body mass index >35, and previous upper abdominal surgery. The primary study outcome was quality of life measured with the Gastro-Esophageal Reflux Disease-Health Related Quality of Life (GERD-HRQL) questionnaire. Secondary outcomes were proton pump inhibitors (PPI) use, presence of gas-related symptoms or dysphagia, and reoperation-free probability.Between March 2007 and July 2014, 238 patients with GERD met the criteria of inclusion in the study. Of these, 103 underwent an LTF and 135 a LINX procedure. All patients had a minimum 1-year follow-up. Over time, patients in both groups had similar GERD-HRQL scores (odds ratio [OR] 1.04, confidence interval [CI] 0.89-1.27; P = 0.578), PPI use (OR 1.18, CI 0.81-1.70; P = 0.388), gas-related symptoms (OR 0.69, CI 0.21-2.28; P = 0.542), dysphagia (OR 0.62, CI 0.26-1.30; P = 0.241), and reoperation-free probability (stratified log-rank test = 0.556).In 2 concurrent cohorts of patients with early stage GERD undergoing LTF or LINX and matched by propensity score analysis, health-related quality of life significantly improved and GERD-HRQL scores had a similar decreasing trend over time up to 7 years of follow-up. We conclude that LTF and LINX provide similar disease-specific quality of life over time in patients with early stage GERD.
authors.affiliation: Department of Biomedical Sciences for Health, Division of General Surgery, University of Milan Medical School, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy.
authors.forename: Emanuele
authors.initials: E
authors.lastname: Asti
authors.forename: Gianluca
authors.initials: G
authors.lastname: Bonitta
authors.forename: Andrea
authors.initials: A
authors.lastname: Lovece
authors.forename: Veronica
authors.initials: V
authors.lastname: Lazzari
authors.forename: Luigi
authors.initials: L
authors.lastname: Bonavina
mesh_terms: D000328:Adult; D000368:Aged; D015331:Cohort Studies; D004943:Esophagogastric Junction / Q000601:surgery*; D005260:Female; D018662:Fundoplication / Q000379:methods* / Q000523:psychology*; D005764:Gastroesophageal Reflux / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy / Q000379:methods* / Q000523:psychology*; D008137:Longitudinal Studies; D059346:Magnets; D008297:Male; D008875:Middle Aged; D061646:Operative Time; D011183:Postoperative Complications / Q000523:psychology*; D057216:Propensity Score; D019736:Prostheses and Implants; D011788:Quality of Life / Q000523:psychology*; D011795:Surveys and Questionnaires