کمیته تحقیقات دانشجویی دانشگاه علوم پزشکی بقیه الله (عج)

In 2005 a double-blinded randomized controlled trial (RCT) looked at the differences between open and laparoscopic cholecystectomy. This raises issues on both the place and validity of double-blinded RCTs in surgery.

Overcoming established treatments always has difficulties, as when faced with either surgery or a non-operative management, everyone's preference would be to avoid surgery (with the complications of pain, scarring, etc.), especially if there is equipoise about which treatment is superior. Operations are also technically complex, and the skill required to perform them well has to be learned. The negative influence of the learning curve for a new treatment must be considered and this may take time to overcome. Furthermore, controlling the bias introduced by interperformer and patient variance is impossible (both in the trial and the “real world”), not least because each patient is different. There are also inherent difficulties in double-blinding surgical treatment, though the imaginative extents to which researchers will go are admirable. “Sham” surgery remains an contentious issue.

Incidentally, the trial showed that laparoscopic patients were discharged sooner, albeit on the same 2nd day of the stay, with no other major differences.