Table 4.
Schedule of enrolments, interventions and assessments
| Study period | |||||||||||
| Enrolment | Allocation | Post-allocation | Close-out | ||||||||
| Timepoint | −t1 | Surgery | POD1 | POD2 | POD3 | POD5–7 | 1 month | 3 months | 6 months | 9 months | 1 year |
| Enrolment: | |||||||||||
| Eligible screen | ※ | ||||||||||
| Informed consent | ※ | ||||||||||
| Allocation | ※ | ||||||||||
| Intervention: | |||||||||||
| TRDG group | ※ | ||||||||||
| TLDG group | ※ | ||||||||||
| Assessments: | |||||||||||
| Operation time (min) | ※ | ||||||||||
| Estimated blood loss (mL) | ※ | ||||||||||
| Retrieved lymph nodes (n) | ※ | ||||||||||
| First flatus time (n) | ※ | ※ | ※ | ※ | |||||||
| Anastomotic-related complications (n) | Until postoperative 1 month | ||||||||||
| Postoperative morbidity (n) | Until postoperative 1 month | ||||||||||
| Postoperative mortality (n) | |
Until postoperative 1 month | |||||||||
| Postoperative hospital stay (n) | ※ | Until the day of discharge | |||||||||
| QOL questionnaire | ※ | ※ | ※ | ※ | ※ | ||||||
| Survival status 1-year OS and DFS |
※ | ※ | ※ | ※ | ※ | ※ | ※ | ※ | ※ | ||
DFS, disease-free survival; OS, overall survival; POD, postoperative day; QOL, quality of life; TLDG, totally laparoscopic distal gastrectomy; TRDG, totally robotic distal gastrectomy.