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Table 1 Sample size calculation for a large trial (RL round ligament, IPL infundibulopelvic ligament)

From: A clinical evaluation of the LOTUS ultrasonic shears in gynaecological surgery

 

Delta

Sigma

Sample size

+5% inflation

Times (s): IP ligament

7.5

15.3

35

37

RL thermal damage: 2 mm

1.5

6.2

136

143

RL thermal damage: 6 mm

0.2

3.8

2835

2977

IPL thermal damage: 2 mm

2.6

7.6

69

73

IPL thermal damage: 6 mm

1.8

6.1

92

97

  1. Sample size calculation: alpha =0.05 (5%); power 80%; delta = difference in group means; sigma = standard deviation of difference in the response of matched pairs
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