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    Interventional procedure overview of endoluminal gastroplication for gastro-oesophageal reflux disease

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    Efficacy summary

    Reduction in GORD symptoms

    In a systematic review and meta-analysis of 1,475 people, the standard mean difference (SMD) between Gastro-oesophageal Reflux Symptom Score (GERSS) before and after all procedures (follow-up range 6 to 24 months) was 23.78 (95% CI 22.96 to 24.60; 6 studies, n=507; p<0.001; I2=98%), the SMD between the RSI before and after all procedures was 14.28 (95% CI 13.56 to 15.01; 8 studies, n=590; p<0.001; I2=95%), and the proportion of patients reporting resolution of hiatal hernia post-procedure was 91% (95% CI 83% to 98%; 12 studies; p < 0.001, I2=85.8%; McCarty 2018).

    In an evidence synthesis of 580 people (done as part of a Health Technology Assessment [HTA]), of 3 studies reporting on heartburn, 1 study reported a statistically significant improvement between baseline and 6 months according to both GORD-HRQL (scored 0 to 30 for heartburn with higher scores indicating greater severity) (17.69 to 3.74, p<0.001) and mean RDQ score across all heartburn items (scored 0 to 5 with higher scores indicating greater severity) (2.6 to 0.5, p<0.001). A second study reported a statistically significant improvement in mean RDQ across all heartburn related items from a mean of 2.99 at baseline to 0.45 at 6-month follow up (p<0.001) but no statistically significant difference between the intervention and control group (p=0.936; Grössmann 2021).

    In a case series of 50 people, the mean heartburn score (scored 0 to 30 with higher scores indicating increased severity) for people decreased from a mean of 18±9 at baseline to 8±7 at 2 years (n=45, p<0.01), 9±8 at 3 years (n=45, p<0.01), 4.5±4.6 at 5 years (n=34, p<0.01), 4.6±4.7 at 7 years (n=24, p<0.01), and 4.2±3 at 10-year follow up (n=12, p<0.01).

    In the same study, the mean regurgitation score (scored 0 to 30 with higher scores indicating increased severity) decreased from a mean of 17±9 at baseline to 9±6 at 2 years (n=45, p<0.01), 10±6 at 3 years (n=45, p<0.01), 3.2±4.3 at 5 years (n=34, p<0.01), 3.3±4.4 at 7 years (n=24, p<0.01), and 3.2±4.4 at 10-year follow up (n=12, p<0.01; Testoni 2019).

    In the evidence synthesis of 580 people from 3 studies reporting on regurgitation, 1 study reported a statistically significant improvement between baseline and 6 months according to mean RDQ score across all regurgitation items (items (scored 0 to 5 with higher scores indicating greater severity) (2.94 to 0.19, p<0.001). A second study reported a statistically significant improvement in mean RDQ score across all regurgitation items from a 3.5 at baseline to 0.5 at 6-month follow up (p<0.001) but no statistically significant difference between the intervention and control group (p=0.072). A third study reported a statistically significant improvement in regurgitation between treatment groups (p=0.01) at 12 months according to a non-validated score. (Grössmann 2021).