Randomization and Blinding
Patients were enrolled in the trial by each participating surgeon after signing the informed consent agreement. The study was a single-blind trial, with only the patients blinded to the surgical procedure.The coordinating center was responsible for patient allocation (CME or non-CME). The randomization list was managed through a central computerized module. A permuted block randomization of size 30 stratified by the center was centrally implemented. The random assignment sequence was concealed until the procedure was allocated to the patients.No blinding was applied after group assignment. The assigned arm of the study was communicated to the surgeon only a few minutes before surgery.