Comparison of 24-hour pH impedance study results between endoscopic full-thickness plication (EFTP) and sham groups at 3 and 12 months after intervention
Parameter | EFTP | P value Baseline versus 3 and 12 months | Sham | P value Baseline versus 3 and 12 months | P value EFTP versus sham | |
Median % time oesophageal pH <4 | Baseline | 4.4 (2.0–8.7) | 2.7 (1.3–5.9) | 0.127 | ||
3 months | 3.6 (0.4–9.0) | 0.422 | 3.5 (1.4–6.4) | 0.915 | 0.833 | |
12 months | 3.4 (0.6–5.5) | 0.276 | 5.4 (2.0–9.0) | 0.441 | 0.111 | |
DeMeester Score | Baseline | 15.1 (7.6–28.0) | 12.2 (6.8–21.4) | 0.447 | ||
3 months | 14.2 (1.7–29.3) | 0.447 | 14.7 (6.2–20) | 0.749 | 0.934 | |
12 months | 21.5 (11.0–49.2) | 0.231 | 20.1 (9.7–27.5) | 0.343 | 0.504 | |
Total reflux episodes | Baseline | 90 (65–115) | 92 (65–130) | 0.733 | ||
3 months | 66 (46–92) | 0.005 | 85 (61–122) | 0.055 | 0.072 | |
12 months | 54.5 (33–100) | 0.122 | 120 (69.5–129) | 0.859 | 0.051 | |
Acid reflux episodes | Baseline | 51 (33–73) | 40 (27–61) | 0.106 | ||
3 months | 34 (16–63) | 0.063 | 40 (30–62) | 0.933 | 0.414 | |
12 months | 31.5 (17.5–73.5) | 0.316 | 66 (47–69) | 0.260 | 0.227 | |
Non-acid reflux episodes | Baseline | 34 (18–71) | 49 (25–77) | 0.264 | ||
3 months | 23 (12–42) | 0.054 | 35 (21–70) | 0.077 | 0.048 | |
12 months | 11.5 (2.5–21.8) | 0.038 | 50 (25.5–62.5) | 0.214 | 0.005 |
All continuous data are expressed as median (IQR).