Laparoscopic insertion of an inactive implant for gastro-oesophageal reflux disease

NICE did a rapid review of the published literature on the efficacy and safety of this procedure. This comprised a comprehensive literature search and detailed review of the evidence from 6 sources, which was discussed by the committee. The evidence included 1 prospective observational study, 3 retrospective cohort studies, 2 retrospective chart reviews that did subgroup analyses of 1 of the retrospective cohort studies, and 1 follow-up analysis of the people included in the prospective observational study. It is presented in the summary of key evidence section in the interventional procedures overview. Other relevant literature is in table 5 of the overview.

The professional experts and the committee considered the key efficacy outcomes to be an improved health-related quality of life score (such as on the GastroEsophageal Reflux Disease Health Related Quality of Life [GERD‑HRQL] scale), rate of odynophagia, protein pump inhibitor use, and 24‑hour pH monitoring.

The professional experts and the committee considered the key safety outcomes to be: device erosion and Clavien–Dindo rating of surgical adverse events.

Six commentaries from people who have experienced this procedure were received, which were discussed by the committee.

The committee noted that this procedure does not encircle the oesophagus. So, it can be used as a treatment option for people with ineffective oesophageal motility. The committee also noted that this procedure may result in less bloating than other procedures.

The committee acknowledged that unpublished evidence on this procedure reports similar safety and efficacy outcomes to the published data.

The committee was informed that this procedure should be done by healthcare professionals with experience of laparoscopic techniques for anti-reflux surgery and specific training in this procedure.