Unsedated ultrathin upper endoscopy is better than conventional endoscopy in routine outpatient gastroenterology practice: A randomized trial

Table 1 Demographic and clinical data of the patients

	TN-EGD	TO-EGD	C-EGD	P
Patients (n)	45	41	53
Gender (m/f)	22/23	15/26	24/29	NS
Age (yr; mean ± SD)	45.73 ± 12.59	43.92 ± 14.97	43.83 ± 13.68	NS
Patients with previous EGD, n (%)	17 (37.7)	17 (41.4)	19 (35.8)	NS
Baseline anxiety score in VAS (mean ± SD)	45.36 ± 27.71	44.34 ± 32.25	45.84 ± 30.35	NS
Baseline oxygen saturation (%; mean ± SD)	98.58 ± 1.41	98.48 ± 1.38	98.47 ± 1.54	NS
Baseline hart rate (bpm; mean ± SD)	84.92 ± 16.12	86.07 ± 15.80	86.32 ± 15.01	NS
Successful completion EGD, n (%)	41 (91.1)	40 (97.5)	51 (96.2)	NS
Duration of EGD (min; mean ± SD)	3.11 ± 1.60	2.25 ± 1.45	2.49 ± 1.64	< 0.05
Tachycardia, n (%)	1 (2.4)	1 (2.5)	3 (5.9)	NS
Blood oxygen desaturation, n (%)	0 (0)	0 (0)	2 (3.9)	NS
Biopsy during EGD, n (%)	19 (46.3)	16 (40.0)	24 (47.0)	NS
Complications, n (%)	1 (2.4)	0 (0)	0 (0)	NS

Table 2 Patients’ and endoscopists’ evaluations (mean ± SD)

	TN-EGD (n = 41)	TO-EGD (n = 40)	C-EGD (n = 51)	P	Statistical procedure
Patients’ assessment
Intubation (pain)	24.49 ± 21.70	20.08 ± 23.46	26.53 ± 31.18	NS	ANOVA-RM
Overall discomfort	22.49 ± 23.59	32.35 ± 28.65	34.02 ± 31.21	NS	ANOVA-RM
Choking	9.66 ± 13.44	19.72 ± 25.80	25.37 ± 33.77	NS	Kruskal-Wallis
Nausea/Vomiting	21.80 ± 26.89	39.57 ± 34.40	35.39 ± 34.27	NS	Kruskal-Wallis
Overall tolerance	3.95 ± 0.71	3.70 ± 0.72	3.29 ± 0.90	< 0.001	ANOVA-RM
Endoscopists’ assessment
Difficulty in intubation	10.97 ± 16.71	6.57 ± 10.37	9.61 ± 14.78	NS	Kruskal-Wallis
Intubation (pain)	16.34 ± 18.37	15.00 ± 17.48	20.10 ± 25.56	NS	ANOVA-RM
Overall discomfort	8.22 ± 9.76	14.85 ± 16.84	23.04 ± 27.31	NS	ANOVA-RM
Overall tolerance	4.56 ± 0.59	4.18 ± 0.93	3.63 ± 1.08	< 0.01	ANOVA-RM

Table 3 Answers to the questions of “how did you tolerate EGD and what you were expecting of?”

	TN-EGD(n = 41)	TO-EGD(n = 40)	C-EGD(n = 51)
Worse than expected, n (%)	2 (4.9)	7 (17.5)	12 (23.5)
As expected, n (%)	9 (21.9)	11 (27.5)	19 (37.3)
Better than expected, n (%)	30 (73.2)	22 (55.0)	20 (39.2)

Table 4 Results of the endoscopists’ evaluation of the performances of endoscopes

	TN-EGD(n = 41)	TO-EGD(n = 40)	C-EGD(n = 51)	P
Endoscopists’ score (mean ± SD)
Image quality	87.85 ± 14.34	89.57 ± 11.00	91.98 ± 11.85	NS
Suction	81.90 ± 9.98	84.82 ± 11.82	94.37 ± 7.49	< 0.001
Air insufflation/washing of the lens	83.90 ± 13.70	85.80 ± 13.34	94.76 ± 6.49	< 0.001
Reaching of the second portionof the duodenum, n (%)	41 (100)	40 (100)	51 (100)	NS
Adequate biopsy sampling, n (%)	19/19 (100)	16/16 (100)	24/24 (100)	NS