Investigator meeting and calibration
CRF, FM
CRF
Prior to the start of the study, a calibration meeting was held with each examiner to standardize data acquisition and the assessment of study variables. Two examiners (IM, FM), who did not perform the surgeries, were designated to collect patient information in the records, to explain to patients how to fill out the morbidity questionnaires and collect them once returned, and to transfer the information unto the data extraction template (CRF). All collected data were stored in an electronic database.