Methods of quality assurance in multicenter trials in laparoscopic fundoplication for gastroesophageal reflux disease.

ABSTRACT

BACKGROUND: Operative performance may affect the internal and external validity of randomized trials. The aim of this study was to review the use of surgical quality assurance mechanisms of published trials on laparoscopic anti-reflux surgery, with the objective to appraise their internal (research quality) and external validity (applicability to the clinical setting). METHODS: Building upon a previous systematic review and network meta-analysis published by the authors, Medline, Embase, AMED, CINAHL, CENTRAL, and OpenGrey databases were searched for randomized control trials comparing different methods of laparoscopic anti-reflux surgery for the management of gastroesophageal disease. Quality assurance in individual studies was appraised using a specified framework addressing surgeon accreditation, procedure standardization, and performance monitoring. RESULTS: In total, 2276 articles were screened to obtain 43 publications reporting 29 randomized controlled trials. Twenty-five out of 43 (58.1%) articles reported the number of participating centers and surgeons involved. Additionally, only 21/43 (48.8%) of articles reported consistent use of a bougie, while 23/43 (53.5%) of articles reported consistent division of the short gastric arteries during fundoplication. Surgical experience and credentials were stated in half of the studies. Standardization of the technique was reported in almost 70% of cases, whereas operative notes or video was submitted in one fourth of the studies. Monitoring of the operative performance during the trial was not documented in most of the trials (62%). CONCLUSION: Surgical quality assurance in randomized trials on laparoscopic anti-reflux surgery is insufficient, which does not allow appraisal of the internal and external validity of this research. With improved reporting, trials assessing the use of laparoscopic anti-reflux surgery will enable surgeons to make informed treatment decisions to enhance patient care in the surgical management of GERD.