Longitudinal comparison of quality of life in patients undergoing laparoscopic Toupet fundoplication versus magnetic sphincter augmentation

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.

Laparoscopic magnetic sphincter augmentation versus double-dose proton pump inhibitors for management of moderate-to-severe regurgitation in GERD: a randomized controlled trial

“…15 Durability has been assessed out to 5 years, and there has been little deterioration in success over time, with 85% or more of patients experiencing relief of typical GERD symptoms without requiring daily acidsuppressive medication. 18,19,38 The success of MSA in controlling regurgitation seen in this study is in line with previous MSA studies. 19 Surgical treatment for refractory GERD often is overlooked or discounted for a variety of reasons: concern about durability, side effects, and the presumption that refractory GERD symptoms are not in fact because of GERD.…”

Systematic review of the introduction and evaluation of magnetic augmentation of the lower oesophageal sphincter for gastro-oesophageal reflux disease

“…Five, including the RCT, reported differences in patient baseline demographics, including hernia size, obesity, age, DeMeester score and disease severity, which were not accounted for in analyses. Although four reported ‘matched’ controls, there were differences in demographics in three.…”

“…). A total of 39 full‐text papers, published between 2008 and 2019, were finally included. The 39 articles consisted of one RCT, five comparative cohort studies (2 prospective and 3 retrospective), three comparative case–control studies, 25 case series (14 prospective, 11 retrospective) and five case reports ( Fig .…”

Ineffective esophageal motility: Concepts, future directions, and conclusions from the Stanford 2018 symposium

“…Earlier concerns regarding postoperative dysphagia following Nissen fundoplication in conventional manometry‐based IEM have been refuted by four small randomized controlled trials demonstrating similar overall outcomes after a partial (Toupet or Dor) fundoplication. Ineffective esophageal motility is a relative contraindication for magnetic sphincter augmentation (MSA), as peristalsis provides propulsive force to distend the magnetic band of the MSA device . Statistically significant augmentation of proportions of intact peristaltic sequences and of distal esophageal amplitudes has been reported in IEM following fundoplication .…”

“…Ineffective esophageal motility is a relative contraindication for magnetic sphincter augmentation (MSA), as peristalsis provides propulsive force to distend the magnetic band of the MSA device. 112,113 Statistically significant augmentation of proportions of intact peristaltic sequences and of distal esophageal amplitudes has been reported in IEM following fundoplication. 104,105,114 In contrast, Booth et al and Mello et al found that while some IEM patients exhibited improvement, others had a decline in peristalsis, and some with normal peristalsis pre-operatively developed IEM postoperatively.…”