Table 2 Principal outcomes.
| Primary outcome | Liberal diet | 1-day LRD | Relative risk (95% CI)* | Non-inferiority risk difference † | One-sided 95%CI † | Number of patients with missing data |
| *The confidence intervals for the secondary outcomes have not been corrected for multiple comparisons, and no clinical conclusions can be drawn from these data. For quantitative variables, the relative risks were calculated for high values (above the median) as compared with low values (at or below the median). †Values shown are percentages. ‡Values shown are medians and interquartile ranges (IQRs) | ||||||
| ITT analysis; adequate cleansing – no. (%) n=553 | 268/278 (96.4) | 269/275 (97.8) | 0.99 (0.96–1.01) | 1.42 | 4.12 | 0 |
| Secondary outcomes | ||||||
| Diet tolerability – Likert Scale 1 and 2 – no. (%) | 282 (94.7) | 228 (83.2) | 1.14 (1.07–1.21) | 13 | ||
| Cleansing solution tolerability – Likert Scale 1 and 2 – no. (%) | 187 (67.8) | 186 (67.9) | 1.00 (0.89–1.12) | 3 | ||
| Satisfaction with the instructions received – Likert Scale 1 and 2 – no. (%) | 264 (95.7) | 265 (96.7) | 0.99 (0.96–1.02) | 3 | ||
| Would have preferred to be assigned to the other study group | 10 (3.6) | 31 (11.3) | 0.32 (0.16–0.64) | 5 | ||
| Excellent cleansing, BBPS 9 – no. (%) | 158 (56.8) | 179 (65.1) | 0.87 (0.76–1.00) | 0 | ||
| Colonoscopy efficiency | ||||||
| Cecal intubation time – minutes, median (IQR) ‡ | 6 (3) | 6 (4) | 0.96 (0.80–1.16) | 2 | ||
| Withdrawal time – minutes, median (IQR) ‡ | 14 (10) | 13(9) | 1.13 (0.94–1.37) | 2 | ||
| Total colonoscopy time – minutes median (IQR) ‡ | 21 (12) | 20 (11) | 1.03 (0.86–1.23) | 0 | ||
| Aspirate volume – mL, median (IQR) ‡ | 400 (200) | 400 (280) | 1.06 (0.90–1.24) | 1 | ||
| Cecal intubation – no. (%) | 276 (99.3) | 274 (99.6) | 1.00 (0.98–1.01) | 0 | ||
| Polyp detection rate – no. (%) | 198 (71.2) | 183 (66.5) | 1.07 (0.96–1.20) | 0 | ||
| Polyp in right colon detection rate – no. (%) | 95 (34.2) | 85 (30.9) | 1.10 (0.87–1.41) | 0 | ||
| Flat polyp detection rate – no. (%) | 35 (12.6) | 22 (8) | 1.57 (0.63–2.12) | 0 | ||
| Adenoma detection rate – no. (%) | 171 (61.5) | 152 (55.3) | 1.11 (0.97–1.28) | 0 | ||
| Adenoma in right colon detection rate – no. (%) | 80 (28.8) | 71 (25.8) | 1.11 (0.85–1.46) | 0 | ||
| Serrated adenoma detection rate – no. (%) | 35 (12.6) | 30 (10.9) | 1.15 (0.73–1.83) | 0 | ||
| Serrated adenoma in right colon detection rate – no. (%) | 21 (7.6) | 18 (6.5) | 1.15 (0.63–2.12) | 0 | ||
| Average detection of polyps – median (IQR) | 2 (3) | 2 (3) | 0.95 (0.75–1.20) | 0 | ||
| Average detection of polyps in the right colon – median (IQR) ‡ | 1 (1) | 1 (1) | 1.19 (0.85–1.68) | 0 | ||
| Average detection of adenomas – median (IQR) ‡ | 2 (2) | 2 (2) | 0.83 (0.61–1.15) | 0 | ||
| Average detection of adenomas in right colon – median (IQR) ‡ | 1 (1) | 1 (1) | 1.19 (0.80–1.77) | 0 | ||