Randomized Controlled Trials for Evaluating Surgical Questions

Abstract

The nature of the RCTs is that they are difficult to use to evaluate surgical techniques. Some options are available to minimize these difficulties. Designing and conducting RCTs to evaluate surgical interventions require careful planning and some compromises. Unless the previously mentioned criteria are applied, the validity of the RCT can be considered no greater than that of other trials.

Wound morbidity in mini-invasive thyroidectomy

“…Certainly, a prospective randomized trial conducted with at least two arms relies heavily on the [29,30]. This clinical equipoise may not exist any longer because most patients were unwilling to accept randomization into a non-VAT control group [29,30]. The results of this analysis must be interpreted with this in mind.…”

Interventions for foot disease in rheumatoid arthritis: A systematic review

“…In addition, surgeons often believe they know the best treatment for a patient; in the absence of genuine equipoise concerning 2 treatments, it is ethically difficult to enter a patient into a study. Initiating trials of surgical procedures is therefore difficult (46,47) Much of the evidence in this systematic review was from non-RCT studies. Such observational studies cannot provide definitive statements on efficacy but give insights into treatment benefits.…”

A systematic review of concomitant interventions to prevent persistent perforations following the removal of long-term ventilation tubes

“…The authors propose randomised controlled trials are warranted using guidance on their conduct in surgery to optimise design [25][26][27]. Reviewing the practice at our own tertiary referral centre revealed approximately 15 patients undergoing removal of a ventilation tube during a 6-month period.…”