A systematic review and analysis of factors associated with methodological quality in laparoscopic randomized controlled trials.

ABSTRACT

Several methods for assessment of methodological quality in randomized controlled trials (RCTs) have been developed during the past few years. Factors associated with quality in laparoscopic surgery have not been defined till date. The aim of this study was to investigate the relationship between bibliometric and the methodological quality of laparoscopic RCTs. The PubMed search engine was queried to identify RCTs on minimally invasive surgery published in 2012 in the 10 highest impact factor surgery journals and the 5 highest impact factor laparoscopic journals. Eligible studies were blindly assessed by two independent investigators using the Scottish Intercollegiate Guidelines Network (SIGN) tool for RCTs. Univariate and multivariate analyses were performed to identify potential associations with methodological quality. A total of 114 relevant RCTs were identified. More than half of the trials were of high or acceptable quality. Half of the reports provided information on comparative demo graphic data and only 21% performed intention-to-treat analysis. RCTs with sample size of at least 60 patients presented higher methodological quality (p = 0.025). Upon multiple regression, reporting on preoperative care and the experience level of surgeons were independent factors of quality.