Trial flow chart | |||||||||
---|---|---|---|---|---|---|---|---|---|
Stage | Preoperative | Intraoperative | Postoperative | Unplanned follow-up | |||||
Follow up period | 2–3 days | 1 day | Intraoperative | 1 day | 3 days | 5 days | 14 days | 30 days | Unplanned follow-up |
Baseline data collected | √ | — | — | — | — | — | — | — | — |
inclusion and exclusion | √ | — | — | — | — | — | — | — | — |
Sign informed consent | √ | — | — | — | — | — | — | — | — |
Group determination | √ | — | — | — | — | — | — | — | — |
Fill in the basic information | √ | — | — | — | — | — | — | — | — |
Physical examination | √ | — | — | — | — | — | — | — | — |
Imaging examination | √ | — | — | — | If necessary | If necessary | √ | If necessary | If necessary |
Blood routine examination | √ | — | — | — | √ | √ | √ | If necessary | If necessary |
Oral antibiotics | — | √ | — | — | — | — | — | — | If necessary |
Safety observation | — | — | √ | √ | √ | √ | √ | √ | If necessary |
Operational observation | — | — | √ | — | — | — | — | — | If necessary |
Record adverse events | — | — | √ | √ | √ | √ | √ | √ | If necessary |
Other works | √ | √ | √ | √ | √ | √ | √ | √ | If necessary |