Biodegradable stent or balloon dilatation for benign oesophageal stricture: Pilot randomised controlled trial

Table 3 Outcomes

	Endoscopic balloon dilatation				Biodegradable stent				Mean difference	95%CI	P value1	P value2
	mean ± SD	Min	Max	n	mean ± SD	Min	Max	n
Primary endpoint
Dysphagia Score (Average 3 and 6 m)	0.00 ± 0.00	0.00	0.00	5	1.17 ± 0.90	0.00	3.00	9	1.17	0.63-1.78	0.029	0.004
Secondary endpoints
Dysphagia Score (AUC 0-6 m)	0.25 ± 0.13	0.13	0.38	5	0.71 ± 0.46	0.25	1.50	9	0.46	0.16-0.78	0.045	0.042
Dysphagia Score (Average 3, 6 and 12 m)	0.00 ± 0.00	0.00	0.00	4	1.21 ± 1.08	0.00	3.33	8	1.21	0.56-2.00	0.052	0.016
Dysphagia Score (AUC 0-12 m)	0.22 ± 0.12	0.13	0.38	4	1.28 ± 1.01	0.25	3.25	8	1.06	0.43-1.81	0.066	0.008
QALY (EQ5D 0-6 m)	0.34 ± 0.16	0.18	0.50	5	0.35 ± 0.10	0.22	0.48	9	0.00	-0.15-0.15	0.995	1.000
QALY (EQ5D 0-12 m)	0.64 ± 0.42	0.14	1.00	4	0.66 ± 0.23	0.38	0.98	7	0.01	-0.38-0.47	0.949	0.927
QALY (EQVAS 0-6 m)	0.36 ± 0.09	0.24	0.46	5	0.32 ± 0.09	0.22	0.45	9	-0.04	-0.14-0.05	0.385	0.364
QALY (EQVAS 0-12 m)	0.73 ± 0.20	0.49	0.92	4	0.67 ± 0.21	0.42	0.94	7	-0.07	-0.29-0.18	0.602	0.648
Number of additional procedures (0-6 m)	0.80 ± 1.10	0.00	2.00	5	3.22 ± 2.91	0.00	8.00	9	2.42		0.127
Number of endoscopic procedures (0-6 m)	0.00 ± 0.00	0.00	0.00	5	0.33 ± 0.71	0.00	2.00	9	0.33		0.505
Number of balloon procedures (0-6 m)	0.40 ± 0.55	0.00	1.00	5	1.22 ± 1.39	0.00	4.00	9	0.82		0.275
Number of endoscopies (0-6 m)	0.40 ± 0.55	0.00	1.00	5	1.67 ± 1.50	0.00	4.00	9	1.27		0.107
Number of additional procedures (0-12 m)	1.20 ± 0.84	0.00	2.00	5	4.13 ± 3.87	0.00	10.0	8	2.93		0.165
Number of endoscopic procedures (0-12 m)	0.00 ± 0.00	0.00	0.00	5	0.63 ± 1.06	0.00	3.00	8	0.63		0.417
Number of balloon procedures (0-12 m)	0.40 ± 0.55	0.00	1.00	5	1.38 ± 1.77	0.00	5.00	8	0.98		0.385
Number of endoscopies (0-12 m)	0.80 ± 0.45	0.00	1.00	5	2.13 ± 1.89	0.00	5.00	8	1.33		0.203

¹Continuous measures: bootstrap estimation, 10000 replications; count data: Fisher’s exact test for trend;

²Continuous measures: independent samples Mann-Whitney U Test (exact significance).