Table 2.
Primary efficacy parameters
| Parameter statistics | Hand-sutured | Stapled |
|---|---|---|
| (n = 138) | (n = 142) | |
| Time of anastomosis (minutes)a | ||
| n | 138 | 142 |
| LS mean (SE) | 20.6 ± 1.90 | 17.6 ± 1.90 |
| 95 % CI | 13.2, 28.0 | 10.2, 25.1 |
| Between group comparisonb, c | ||
| LS mean (SE) | 2.9 ± 0.80 | |
| 95 % CI | 1.4, 4.5 | |
| P value | 0.0003 | |
| Adjusted P valued | 0.0008 | |
| Time of surgery (minutes)e | ||
| n | 138 | 142 |
| LS mean (SE) | 168.4 ± 47.40 | 172.7 ± 47.40 |
| 95 % CI | −32.8, 369.7 | −28.5, 373.9 |
| Between group comparisonb, c | ||
| LS mean (SE) | −4.3 ± 7.69 | |
| 95 % CI | −19.4, 10.9 | |
| P value | 0.5781 | |
| Adjusted P valued | 0.7774 | |
| Return to bowel activity time (days)f | ||
| n | 132g | 142 |
| LS mean (SE) | 4.2 ± 0.71 | 4.0 ± 0.71 |
| 95 % CI | 1.2, 7.1 | 1.0, 6.9 |
| Between group comparisonb, c | ||
| LS mean (SE) | 0.2 ± 0.21 | |
| 95 % CI | −0.2, 0.6 | |
| P value | 0.3887 | |
| Adjusted P valued | 0.7774 | |
a Time of anastomosis = total time (minutes) from placement of stay suture to final anastomotic staple (stapled) or final anastomotic suture (hand-sutured)
b LS mean, SE, 95 % CI, and P value were obtained from ANOVA mixed model with treatment group and anastomosis type as fixed effects, and trial site as random effect
c Between treatment comparison was calculated as hand-sutured minus stapled
d Adjusted P value was obtained from the Bonferroni-Holm step-down adjustment to the raw P values obtained from the between group comparison for each of the three primary efficacy comparisons
e Time of surgery = total time (minutes) from first incision (skin open) to last suture (skin close)
f Bowel activity time = total time (days) postsurgery to appearance of peristaltic movement
g Days to return to bowel activity were missing for 6 of the subjects who died
ANOVA = analysis of variance; CI = confidence interval; LS = least square; SD = standard deviation; SE = standard error