Adverse events associated with transoral incisionless fundoplication (TIF) for chronic gastroesophageal reflux disease: a MAUDE database analysis

Abstract Background Given poor symptomatic response rates and rising awareness of the adverse events associated with the long-term use of proton pump inhibitors (PPIs), endoscopic modalities for treatment of refractory gastroesophageal reflux disease (GERD) have become more prominent. The aim of this study was to perform a systematic review and meta-analysis to evaluate feasibility, efficacy, and tolerability of transoral incisionless fundoplication (TIF) for the treatment of refractory GERD. Methods Searches of PubMed, EMBASE, Web of Science, and Cochrane Library databases were performed to March 2017. Measured outcomes included immediate technical success rate and serious adverse events. Symptomatic improvement was measured using GERD Health-related Quality of Life (HRQL), Gastroesophageal Reflux Symptom Score (GERSS), and Reflux Symptom Index (RSI). Objective success was determined by hiatal hernia reduction and pH monitoring. Results 32 studies (1475 patients; 48.2 % male) met inclusion criteria. TIF success rate was 99 % (95 % confidence interval [CI] 97 to 100; P < 0.001), with an adverse event rate of 2 % (95 %CI 1 to 3; P < 0.001). GERD HRQL, GERSS, and RSI improved significantly post-TIF (mean difference 17.72, 95 %CI 17.31 to 18.14; mean difference 23.78, 95 %CI 22.96 to 24.60; mean difference 14.28, 95 %CI 13.56 to 15.01; all P < 0.001, respectively). Hernia reduction occurred in 91 % of patients (95 %CI 83 to 98; P < 0.001). DeMeester scores improved significantly (mean difference 10.22, 95 %CI 8.38 to 12.12; P < 0.001). PPI therapy was discontinued post-procedure in 89 % of patients (95 %CI 82 to 95; P < 0.001). Conclusions TIF appears to be a safe and effective endoscopic procedure for patients with refractory GERD. Future controlled trials are needed to directly compare efficacy, long-term durability, and safety between TIF and Nissen fundoplication.

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675 FUNDOPLICATION VERSUS ORAL PROTON PUMP INHIBITORS FOR GASTROESOPHAGEAL REFLUX DISEASE: A SYSTEMATIC REVIEW AND META-ANALYSIS OF RANDOMIZED CLINICAL TRIALS

Diseases of the Esophagus ◽

10.1093/dote/doab052.675 ◽

2021 ◽

Vol 34 (Supplement_1) ◽

Author(s):

Luca Schiliró Tristão ◽

Francisco Tustumi ◽

Guilherme Tavares ◽

Letícia Nogueira Datrino ◽

Maria Carolina Andrade Serafim ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Gastroesophageal Reflux Disease ◽

Gastroesophageal Reflux ◽

Adverse Events ◽

Proton Pump ◽

Reflux Disease ◽

Randomized Clinical Trials ◽

Meta Analysis ◽

Oral Intake

Abstract Gastroesophageal reflux disease (GERD) is a widely studied and highly prevalent condition. However, few is reported about the exact efficacy and safety of fundoplication (FPT) compared to oral intake proton-pump inhibitors (PPI). This systematic review and meta-analysis of randomized clinical trials (RCT) aims to compare PPI and FPT in relation to the efficacy, as well as the adverse events associated with these therapies. Methods This systematic review was guided by PRISMA statement. Search carried out in June 2020 was conducted on Medline, Cochrane, EMBASE and LILACS. The inclusion criteria were (I) patients with GERD; (II) Randomized clinical trials, comparing oral intake PPI with FPT; (III) relevant outcomes for this review. The exclusion criteria were (I) reviews, case reports, editorials and letters (II) transoral or endoscopic FPT (III) studies with no full text. No restrictions were set for language or period. Certainty of evidence and risk of bias were assessed with GRADE Pro and with Review Manager Version 5.4 bias assessment tool. Results Ten RCT were included. Meta-analysis showed that heartburn (RD = −0.19; 95% CI = −0.29, −0.09) was less frequently reported by patients that underwent FPT. Furthermore, patients undergoing surgery had greater pressure on the lower esophageal sphincter than those who used PPI (MD = 7.81; 95% CI 4.79, 10.83). There was no significant difference between groups in the percentage of time with pH less than 4 in 24 hours, sustained remission and Gastrointestinal Symptom Rating Scale. Finally, FPT did not increase significantly the risk for adverse events such as postoperative dysphagia and impaired belching. Conclusion FPT is a more effective therapy than PPI treatment for GERD, without significantly increasing the risk for adverse events. However, before indicating a possible surgical approach, it is extremely important to correctly assess and select the patients who would benefit from FPT, such as those with severe erosive esophagitis, severe respiratory symptoms, low adherence to continuous drug treatment and patients with non-acid reflux, to ensure better results.

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