Randomised clinical trials in surgery: a look at the ethical and practical issues

Area of Science:

• Medical research methodology
• Surgical evidence generation

Background:

• Randomised controlled trials (RCTs) are fundamental to evidence-based medicine.
• Surgical practice has seen limited adoption of RCTs, facing criticism.
• Several practical and ethical challenges hinder surgeons from conducting RCTs.

Purpose of the Study:

• To explore the reasons behind surgeons' reluctance to conduct RCTs.
• To discuss the practical and ethical considerations in surgical RCTs.
• To propose solutions for improving RCT conduct in surgery.

Main Methods:

• Discussion of practical challenges in surgical RCTs, including blinding and design.
• Examination of ethical issues such as equipoise and sham surgery.
• Review of existing guidelines and ethical norms for clinical trials.

Main Results:

• RCTs have been instrumental in identifying and eliminating unnecessary surgical procedures.
• Practical difficulties like surgical blinding, study design, and funding are significant barriers.
• Ethical considerations, including equipoise and the use of sham controls, present complex challenges.

Conclusions:

• While RCTs are essential, they are not always the sole method for generating evidence in surgery.
• Adherence to guidelines from reputable bodies and strict ethical standards are vital for conducting surgical trials.
• Solutions involve navigating practical hurdles and upholding ethical principles to strengthen surgical evidence.