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    Interventional procedure overview of laparoscopic insertion of an inactive implant for gastro-oesophageal reflux disease

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    Outcome measures

    The main efficacy outcomes include:

    • Gastro-oesophageal reflux disease – health related quality of life (GERD-HRQL) questionnaire score

    • Heartburn subscore (within GERD-HRQL questionnaire)

    • Regurgitation subscore (within GERD-HRQL questionnaire)

    • Dysphagia reduction (within GERD-HRQL questionnaire)

    • Odynophagia

    • Proton pump inhibitor (PPI) usage

    • 24-hour pH monitoring, mean reduction in percentage of time in a pH less than 4

    • Gas bloating subscore (within GERD-HRQL questionnaire)

    • Patient satisfaction subscore (within GERD-HRQL questionnaire)

    Safety measures

    • Clavien–Dindo scale

    The measures used are detailed in the following paragraphs.

    GERD-HRQL score

    The GERD-HRQL questionnaire produces a total score to measure and grade the severity of GORD. It is a patient-reported outcome measure which includes questions and subscores on symptoms such as heartburn and regurgitation.

    There are 2 versions of the questionnaire that have been used by different studies. In one version, the highest possible score is 50, indicating the worst symptoms, and the lowest possible score is 0, indicating no symptoms (Velanovich 1996). This version is used in Bjelovic (2020) and Harsanyi (2024).

    In the second version of the questionnaire, the highest possible score is 75, indicating the worst symptoms, and the lowest possible score is 0, indicating no symptoms. This version is used in Fringeli (2024a, 2024b, 2024c).

    Heartburn subscore

    The heartburn subscore can be calculated from the GERD-HRQL questionnaire. The highest possible score is 30, indicating the worst heartburn symptoms, and the lowest possible score is 0, indicating no heartburn symptoms. Scores of less than 12 and each individual question not exceeding 2 indicates no heartburn.

    Regurgitation subscore

    The regurgitation subscore can be calculated from the GERD-HRQL questionnaire. The highest possible score is 30, indicating the worst regurgitation symptoms, and the lowest possible score is 0, indicating no regurgitation symptoms. Scores of less than 12 and each individual question not exceeding 2 indicates no regurgitation.

    Foregut questionnaire

    The Foregut questionnaire is a symptom-oriented questionnaire used to measure the severity and frequency of dysphagia, heartburn and regurgitation. The questionnaire was used to assess regurgitation scores in 2 papers (Bjelovic 2020 and Harsanyi 2024). The grading system ranges from 0 to 4, where 0 indicates no regurgitation and 4 indicates very severe continuous regurgitation (Makris 2012).

    Dysphagia

    The GERD-HRQL questionnaire has a question relating to dysphagia. Scores can be between 0 and 5. 0 indicates no symptoms and 5 indicates that symptoms are incapacitating.

    Patient satisfaction relating to GORD

    In the GERD-HRQL questionnaire people were asked how satisfied they were with their current quality of life relating to GORD. Possible responses include 'satisfied', 'neutral' or 'dissatisfied'.

    Clavien–Dindo scale

    The Clavien–Dindo scale is a classification system used for grading adverse events in surgical procedures. It is graded from 1 (mild) to 5 (death).