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Table 1 Demographics and clinical characteristics of the study patients at screening

From: Efficacy of transoral fundoplication for treatment of chronic gastroesophageal reflux disease incompletely controlled with high-dose proton-pump inhibitors therapy: a randomized, multicenter, open label, crossover study

Characteristics

TF group (n = 39)

PPI group (n = 21)

p values

Male, n (%)

19 (49)

8 (38)

0.587

Age, years

54.5 (10.4)

50.4 (9.8)

0.151

Body mass index, kg/m2

28.3 (3.9)

29.1 (2.8)

0.422

GERD symptom duration, years

12.5 (11.3)

9.4 (5.7)

0.224

PPI therapy duration, years

9.3 (7.2)

8.1 (5.1)

0.686

Quality of life scores off PPIs

   

 Reflux Disease Questionnaire (RDQ) score

3.7 (1.1)

4.1 (0.7)

0.122

 Regurgitation (RDQ) score off PPIs

3.5 (1.2)

4.1 (0.9)

0.067

 GERD-HRQL score

32.5 (9.6)

33.7 (8.5)

0.625

 Heartburn score (GERD-HRQL)

22.2 (6.3)

23.2 (4.4)

0.519

 Reflux Symptom Index (RSI) score

25.2 (9.3)

28.6 (7.4)

0.150

Total % time pH <4

10.2 (3.5)

10.6 (3.5)

0.665

Patients on single dose of PPI at entry, n (%)

27 (69)

16 (76)

0.765

  1. GERD, gastroesophageal reflux disease; GERD-HRQL, gastroesophageal reflux disease health related quality of life; PPI, proton pump inhibitor; TF, transoral fundoplication.