2.3 Study protocol
This study protocol was approved by the ethics committee of Zhongshan
Hospital Fudan University and was consistent with the Declaration
of Helsinki . All included patients signed an informed consent approved
by the ethics committee. Data collection was performed by trained staff
(two people). The trained staff, however, were not informed of the
purpose of this study.
Baseline and surgical characteristics, and perioperative results were
obtained from our institutional database and were reviewed using a
standard data collection form. Patients were regularly followed up at 3
and 6 months following surgery, respectively, and thereafter at 6-month
intervals. Follow-up data were obtained by a clinic visit, WeChat, or
telephone. In addition, the incidence of major adverse events per
surgeon was calculated and compared. The details of baseline
characteristics, surgical characteristics, perioperative results,
follow-up results, and major adverse events are shown in the additional
file 1.