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Table 3 Comparison of postoperative outcomes and complications

From: Preoperative carbohydrate loading and intraoperative goal-directed fluid therapy for elderly patients undergoing open gastrointestinal surgery: a prospective randomized controlled trial

 

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

  1. Note: Values are absolute (percentage) or mean ± SD (standard deviation)
  2. ITT intention to treat analysis, Per protocol only patients performed intraoperative protocol in full extent, RMB Renminbi, ICU intensive care unit