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Table 4 24-h pH monitoring at Baseline and 6 months post-operation

From: Non-active implantable device treating acid reflux with a new dynamic treatment approach: 1-year results

% overall time pH < 4

Baseline

6 Months

Change Baseline to 6 Months

n

50

45

45

Mean (SD)

16.35% (16.60)

0.80% (1.56)

−16.0 (17.46)

Median

10.55%

0.30%

−10.05

Min, Max

p-value*

4.3, 94.8

0.0, 8.8

−93.4, 0.3

(p < 0.001)

  1. * Paired t-test of the mean change
  2. Two of the subjects refused the burdensome pH-monitoring test whereof one had a successful GERD-HRQL questionnaire score and one subject had a to too low position of the device already at surgery, prohibiting the function of the device. This later subject refused the pH monitoring test and re-surgery