Sciences de la Santé
the quality of training has been altered by this disruption. The supporting evidence is however lacking 5.
8 Printemps 2018
Clinical trials in surgery Another challenge faced in this domain is the difficulty of applying evidence-based methods in surgical trials. Indeed, applying placebo-controlling and blinding in order to bypass biases was often thought impossible in surgical interventions. But even this seemingly impossible task was challenged: 66 surgical placebo-controlled trials were reported in the first 15-years of the 21st century versus 19 in all of the 20th century 4.
But what is placebo-controlling? It is having two groups of patients randomly assigned to each. One would receive the tested operation / drug while the other would receive a sham( fake) procedure or a placebo drug( Placebo: Latin for“ I will please”, is a pharmaceutical preparation lacking any active ingredient).
Why do we“ control” such experiments? We do it to insure their efficacy and superiority to the placebo treatments, verifying thus that the outcome is in fact due to the experimented intervention while eliminating a placebo effect, i. e. the psychological improvement reported after receiving a treatment regardless of its actual efficacy 12.
Why is it done“ randomly”? Randomization guaranties no other factor has influenced the outcome between the two groups other than the difference in the experimented intervention. For example, let’ s say a treatment called T for a disease is about to be tested and controlled with a placebo P in a non-randomized trial. One might put very sick people in the group receiving treatment T and mildly sick people in the group receiving Placebo P. When assessing the outcome, the result was little improvement observed in the T group compared to the P group. Was it due to the treatment itself? Was it not because the individuals in T group were clinically worse than those in P group? We couldn’ t possibly know as we wouldn’ t if the situation was vice versa. A simple solution would be to randomly allocate people to each group, ensuring there’ s no systematic differences between intervention groups in other factors 13.
How would a sham surgery be done? Many examples exist, one of which is seen in faking an orthopedic operation such as a menisectomy. Surgeons are required to use a mechanized shaver to which the blade has been removed. Applying it against the patella mimics the actual operation. Some had to prolong the duration of the sham operation in the control group so as to match that of a real one 4.
As to blinding, it is the case when the patient doesn’ t know what group he belongs to. The operation would be called double-blinded when both the attending physician and patient are in the dark. Thus, eliminating any biases that might be encountered while assessing outcomes 12.
Some of the biases observed in patients that blinding surpasses: if a patient knows he is in the control group, he might not comply with the prescribed medication or protocol( non-compliance). He might also drop out from the trial( attrition bias). Some might seek other treatments elsewhere“ contaminating” the experiment( Co-intervention). In outcome assessors, not knowing which group is which prevents observer bias which is the tendency to assess patients with experimented intervention more favorably 12.
Blinding has been rendered more and more feasible in the field of surgery due to the fact that there’ s an increasing use of implants and energy-emitting tools. The surgeon would simply introduce the catheter in and leave the subsequent procedure for a technician to follow it through, never knowing therefore whether the operation was completed or not 4.
It is regarded by some as unethical to fool a group of patients into thinking they have been operated on when they were simply incised and stitched back up. Others would speculate on the high costs of such procedures. It is, however, necessary to back up surgical results observed in the field with valid data and prevent useless interventions from being utilized at high costs.
Other challenges? Surgeons today still face many challenges. Though history may show them to have conquered many obstacles, we must bring to attention the fact that post-operative pain and sepsis remain major health problems and account for high mortality-rates and care-costs in hospitals throughout the world. Nevertheless, this burden is nowadays shared by both surgeons and other specialists, showing the importance of team work in handling these delicate issues 9, 11.
Furthermore, the frequent use of state-of-the-art techniques as is the case with laparoscopic cholecystectomy may have amputated surgical trainees from learning the open cholecystectomy as once taught before the 1990s. Keeping in mind that if a minimally invasive procedure goes wrong, the conversion to open laparotomy is a must. Acute cholecystitis is one of such cases where the risk of conversion is high 10 which emphasizes the importance of an experimented hand in managing such situations. A solution may come in the form of simulation based re-enactment or SBR 7. SBR offers surgical residents and medical students the chance to revisit the operating theatre and re-enact the classic open cholecystectomy under the supervision of a senior surgeon on a mannequin with animal organs. Not only does it help