Question special

Seventy-five patients were excluded based on having exhausted non-surgical treatment options. Could you please explain why these patients were excluded from the trial? Does that clinical situation lack equipoise in that all patients who have exhausted non-operative treatment options would be offered surgery at 4 months? Additionally, since the wait period for surgery was about 6 months anyhow, the trial would not have prevented those patients from receiving surgery but instead given them a 50% chance of getting surgery much more quickly.

Thank you once again for participating in this journal club and congratulations on a fantastic study!