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| |
GDFT group
|
CFT group
|
p
|
|---|
|
Number of patients
|
|
ITT analysis
|
60
|
60
| |
|
Per protocol analysis
|
55
|
57
| |
|
Primary outcome
|
|
Patients with complications
|
|
ITT analysis
|
15 (25.0%)
|
29 (48.3%)
|
0.013
|
|
Per protocol analysis
|
14 (25.5%)
|
27 (47.4%)
|
0.016
|
|
List of complications (Per protocol analysis only)
|
|
Infection
|
5 (9.1%)
|
13 (22.8%)
|
0.048
|
|
Respiratory
|
5 (9.1%)
|
9 (15.8%)
|
0.284
|
|
Cardiovascular
|
6 (10.9%)
|
9 (15.8%)
|
0.448
|
|
Abdominal
|
6 (10.9%)
|
10 (17.5%)
|
0.316
|
|
Renal
|
1 (1.8%)
|
2 (3.5%)
|
1.000
|
|
Others
|
2 (3.6%)
|
2 (3.5%)
|
1.000
|
|
Secondary outcomes
|
|
Time to first flatus (hours)
|
|
ITT analysis
|
56 ± 14.1
|
64 ± 22.3
|
0.002
|
|
Per protocol analysis
|
55 ± 13.9
|
65 ± 22.6
|
0.004
|
|
Time to first oral taken (hours)
|
|
ITT analysis
|
72 ± 16.9
|
85 ± 26.8
|
0.011
|
|
Per protocol analysis
|
72 ± 17.4
|
85 ± 27.5
|
0.002
|
|
Postoperative hospitalization (days)
|
|
ITT analysis
|
9.1 ± 2.8
|
9.7 ± 3.2
|
0.290
|
|
Per protocol analysis
|
9.2 ± 2.9
|
9.7 ± 3.1
|
0.397
|
|
Amount hospital charges (RMB)
|
|
ITT analysis
|
57,599 ± 16,363
|
62,802 ± 19,891
|
0.120
|
|
Per protocol analysis
|
56,845 ± 16,446
|
60,571 ± 16,579
|
0.235
|
|
Admission to ICU
|
|
ITT analysis
|
6 (10%)
|
7 (11.7%)
|
0.769
|
|
Per protocol analysis
|
5 (9.1%)
|
6 (10.5%)
|
0.799
|
|
Postoperative mortality
|
|
ITT analysis
|
0 (0%)
|
2 (3.5%)
|
0.496
|
|
Per protocol analysis
|
0 (0%)
|
2 (3.3%)
|
0.496
|
- Note: Values are absolute (percentage) or mean ± SD (standard deviation)
- ITT intention to treat analysis, Per protocol only patients performed intraoperative protocol in full extent, RMB Renminbi, ICU intensive care unit
