Impact of cap-assisted colonoscopy during transendoscopic enteral tubing: A randomized controlled trial

Table 1 Baseline characteristics of the study subjects

	RC group, n = 152	CC group, n = 151	P value
Age in yr, mean ± SD	44.4 ± 17.6	46.7 ± 17.0	0.248
Children1, n (%)	4 (2.6)	4 (2.6)	1.000
Male, n (%)	76 (50.0)	79 (52.3)	0.687
Body mass index in kg/m2, mean ± SD	21.1 ± 3.8	21.6 ± 3.3	0.243
Disease category, n (%)
Ulcerative colitis	46 (30.3)	42 (27.8)	0.639
Constipation	43 (28.3)	50 (33.1)	0.363
Irritable bowel syndrome	14 (9.2)	18 (11.9)	0.443
Crohn's disease	6 (3.9)	3 (2.0)	0.501
Healthy volunteers	3 (2.0)	3 (2.0)	1.000
Others2	40 (26.3)	35 (23.2)	0.527
Previous surgery, abdominal or pelvic, n (%)	38 (25.0)	33 (21.9)	0.518

¹Aged ≤ 15 years.

²Other disease categories include antibiotic-associated diarrhea, diabetes, Parkinson’s disease, Tourette's syndrome, autism, epilepsy, cirrhosis, etc. RC: Regular colonoscopy; CC: Cap-assisted colonoscopy.

Table 2 Outcomes related to transendoscopic enteral tubing procedure

	RC group,n = 152	CC group,n = 151	P value
Cecal intubation rate after inserting TET tube, n (%) (%)	148 (97.4)	151 (100)	-
The first cecal intubation time in min, median (IQR)	5.9 (4.3-8.5)	6.2 (4.1-8.3)	0.921
The second cecal intubation time in min, median (IQR)	2.8 (1.8-4.0)	2.2 (1.6-3.2)	0.000
The second cecal intubation time of constipation patients	3.8 (2.2-5.6)	2.6 (1.9-3.7)	0.004
The second cecal intubation time of ulcerative colitis patients	2.5 (1.6-3.5)	2.0 (1.5-3.0)	0.152
Average fixation time per endoscopic clip in min, mean ± SD	1.1 ± 0.4	1.2 ± 0.6	0.238
Number of endoscopic clips, mean ± SD	2.7 ± 1.1	2.6 ± 1.1	0.339
Colonoscopy type, n (%)
Sedated	133 (87.5)	137 (90.7)	0.367
Unsedated	19 (12.5)	14 (9.3)	0.367
Maximum pain score, mean ± SD	5.4 ± 1.9	3.8 ± 1.7	0.015
TET success rate, n (%)	152 (100)	151 (100)	-
Serious adverse event, n (%)	0	0	-
Adverse events, n (%)	4 (2.6)	5 (3.3)	0.750
Anal pain	2 (1.3)	1 (0.7)	1.000
Mild anal discomfort	1 (0.7)	3 (2.0)	0.371
Transient anal bleeding	1 (0.7)	1 (0.7)	1.000

TET: Transendoscopic enteral tubing; RC: Regular colonoscopy; CC: Cap-assisted colonoscopy; IQR: Interquartile range; SD: Standard deviation.

Table 3 Univariate and multivariate analyses of factors associated with the retention time of transendoscopic enteral tube < 8 d

	Univariate analysis		Multivariate analysis
	OR (95%CI)	P value	OR (95%CI)	P value
Age in yr	1.008 (0.992-1.025)	0.343	-		-
Sex, male vs female	1.517 (0.804-2.862)	0.198	1.930 (0.966-3.858)		0.063
Disease type, IBD vs others	0.589 (0.339-1.025)	0.061	0.960 (0.499-1.846)		0.903
Number of endoscopic clips	2.137 (1.546-2.954)	0.000	2.201 (1.541-3.143)		0.000
Grouping, RC vs CC	0.775 (0.455-1.320)	0.348	-		-

IBD: Inflammatory bowel disease; RC: Regular colonoscopy; CC: Cap-assisted colonoscopy.

Table 4 Univariate and multivariate analyses of factors associated with the second cecal intubation time of < 3.1 min in difficult colonoscopy

	Univariate analysis		Multivariate analysis
	OR (95%CI)	P value	OR (95%CI)	P value
Age in yr	1.002 (0.477-2.102)	0.996	-	-
Sex, male vs female	0.930 (0.487-1.774)	0.825	-	-
Body mass index, < 21 vs ≥ 21 kg/m2	0.855 (0.452-1.616)	0.629	-	-
Previous surgery, abdominal or pelvic1	0.868 (0.414-1.822)	0.709	-	-
Colonoscopy, sedated vs unsedated	1.062 (0.406-2.781)	0.902	-	-
Constipation1	0.559 (0.291-1.073)	0.080	0.514 (0.263-1.005)	0.052
Grouping, RC vs CC	2.103 (1.101-4.017)	0.024	2.250 (1.161-4.360)	0.016

¹Without vs with each factor. RC: Regular colonoscopy; CC: Cap-assisted colonoscopy.

Table 5 Univariate and multivariate analyses of factors associated with the length of transendoscopic enteral tube inserted into the colon ≥ 86 cm

	Univariate analysis		Multivariate analysis
	OR (95%CI)	P value	OR (95%CI)	P value
Age in yr	0.996 (0.967-1.025)	0.774	-	-
Height, < 165 vs ≥ 165 cm)	9.750 (2.523-37.675)	0.001	1.144 (1.027-1.275)	0.014
Sex, male vs female	0.352 (0.117-1.062)	0.064	1.184 (0.246-5.693)	0.833
IBD1	1.161 (0.346-3.901)	0.809	-	-
Constipation1	1.212 (0.329-4.466)	0.773	-	-
Grouping, RC vs CC	1.895 (0.645-5.569)	0.245

¹Without vs with each factor. IBD: Inflammatory bowel disease; RC: Regular colonoscopy; CC: Cap-assisted colonoscopy.