Volume and methodological quality of randomized controlled trials in laparoscopic surgery: assessment over a 10-year period

Abstract

Background: Measures have been taken to improve methodological quality of randomized controlled trials (RCTs). This review systematically assessed the trends in volume and methodological quality of RCTs on minimally invasive surgery within a 10-year period.

Data sources: RCTs on minimally invasive surgery were searched in the 10 most cited general surgical journals and the 5 most cited journals of laparoscopic interest for the years 2002 and 2012. Bibliometric and methodological quality components were abstracted using the Scottish Intercollegiate Guidelines Network. The pooled number of RCTs from low-contribution regions demonstrated an increasing proportion of the total published RCTs, compensating for a concomitant decrease of the respective contributions from Europe and North America. International collaborations were more frequent in 2012. Acceptable or high quality RCTs accounted for 37.9% and 54.4% of RCTs published in 2002 and 2012, respectively. Components of external validity were poorly reported.

Conclusions: Both the volume and the reporting quality of laparoscopic RCTs have increased from 2002 to 2012, but there seems to be ample room for improvement of methodological quality.

Keywords: CONSORT; Laparoscopy; Methodological quality; Minimally invasive surgery; Randomized trial; Reporting quality.