Efficacy of thrombin spray combined with clip closure after colorectal endoscopic mucosal resection and endoscopic submucosal dissection

Table 1 Comparison of general data between two groups, n (%)/mean ± SD

Item	Study group (n = 59)	Control group (n = 61)	Statistic	P value
Gender			χ2 = 0.417	0.519
Male	41 (69.5)	38 (62.3)
Female	18 (30.5)	23 (37.7)
Age (years)	56.8 ± 12.5	57.9 ± 13.2	t = 0.476	0.635
BMI (kg/m2)	23.8 ± 2.6	24.1 ± 2.4	t = 0.664	0.508
Lesion location			χ2 = 2.145	0.829
Rectum	18 (30.5)	21 (34.4)
Sigmoid colon	15 (25.4)	16 (26.2)
Descending colon	8 (13.6)	7 (11.5)
Transverse colon	10 (16.9)	9 (14.8)
Ascending colon	6 (10.2)	5 (8.2)
Cecum	2 (3.4)	3 (4.9)
Lesion size (cm)	2.0 ± 1.1	1.9 ± 1.0	t = 0.523	0.602
Surgical method			χ2 = 3.254	0.071
EMR	43 (72.9)	55 (90.2)
ESD	16 (27.1)	6 (9.8)
Comorbid underlying diseases
Hypertension	21 (35.6)	24 (39.3)	χ2 = 0.174	0.677
Diabetes	11 (18.6)	13 (21.3)	χ2 = 0.127	0.721
Coronary heart disease	5 (8.5)	7 (11.5)	χ2 = 0.285	0.593
Preoperative hemoglobin (g/L)	136.4 ± 15.3	138.1 ± 14.8	t = 0.624	0.534
Preoperative platelet count (× 109/L)	218.5 ± 52.3	223.6 ± 49.7	t = 0.551	0.583
Prothrombin time (second)	11.8 ± 1.2	11.6 ± 1.1	t = 0.959	0.339
Activated partial thromboplastin time (second)	28.3 ± 3.6	28.7 ± 3.4	t = 0.627	0.532

BMI: Body mass index; EMR: Endoscopic mucosal resection; ESD: Endoscopic submucosal dissection.

Table 2 Comparison of postoperative bleeding incidence between two groups, n (%)

Bleeding type	Study group (n = 59)	Control group (n = 61)	Statistical method	P value
Immediate postoperative bleeding	1 (1.7)	2 (3.3)	Fisher’s exact test	1
Delayed bleeding	0 (0.0)	1 (1.6)	Fisher’s exact test	1
Total bleeding	1 (1.7)	3 (4.9)	Fisher’s exact test	0.622

Immediate postoperative bleeding refers to bleeding occurring within 24 hours postoperatively; delayed bleeding refers to bleeding occurring from 24 hours to 30 days postoperatively; Fisher’s exact test was used for immediate postoperative bleeding and delayed bleeding due to theoretical frequency < 5.

Table 3 Comparison of intraoperative immediate bleeding control between two groups

Group	Cases	Intraoperative bleeding control (cases)	Intraoperative bleeding control rate (%)	Statistical method	P value
Study group	59	59	100	Fisher’s exact test	0.041
Control group	61	57	93.4	-	-

Intraoperative immediate bleeding control refers to no active bleeding when wound treatment is completed during surgery; among the 4 patients in the control group with incompletely controlled intraoperative bleeding, 2 cases experienced immediate postoperative bleeding, and 2 cases had no further bleeding after enhanced treatment.

Table 4 Comparison of pathological indicators between two groups, n (%)

Item	Study Group (n = 59)	Control Group (n = 61)	Statistic	P value
En bloc resection rate	57 (96.6)	58 (95.1)	χ2 = 0.171	0.679
R0 resection rate	55 (93.2)	56 (91.8)	χ2 = 0.081	0.776
Lesion invasion depth			Fisher’s exact test	> 0.99
Mucosal layer	58 (98.3)	59 (96.7)
Shallow submucosal layer	1 (1.7)	2 (3.3)
Deep submucosal layer	0 (0.0)	0 (0.0)

Fisher’s exact test was used for lesion invasion depth due to theoretical frequency < 5; the P value of > 0.99 reflects a near-identical distribution of invasion depth between groups.

Table 5 Comparison of Visual Analogue Scale scores at different postoperative time points between two groups (points), mean ± SD

Time point	Study group (n = 59)	Control group (n = 61)	t value	P value	Corrected P value
6 hours postoperatively	3.8 ± 1.2	4.6 ± 1.4	3.391	0.001	< 0.0125
12 hours postoperatively	3.2 ± 1.1	3.9 ± 1.3	3.197	0.002	< 0.0125
24 hours postoperatively	2.1 ± 0.9	2.6 ± 1.0	2.885	0.005	< 0.0125
48 hours postoperatively	1.3 ± 0.7	1.5 ± 0.8	1.534	0.128	-

Bonferroni correction was used for multiple comparisons, with corrected significance level α = 0.05/4 = 0.0125.

Table 6 Comparison of Gastrointestinal Symptom Rating Scale scores on postoperative day 7 between two groups (points), mean ± SD

Dimension	Study group (n = 59)	Control group (n = 61)	t value	P value
Abdominal pain syndrome	2.3 ± 0.6	2.8 ± 0.7	4.236	< 0.001
Reflux syndrome	1.8 ± 0.5	2.2 ± 0.6	3.985	< 0.001
Indigestion syndrome	2.1 ± 0.6	2.6 ± 0.7	4.245	< 0.001
Diarrhea syndrome	1.9 ± 0.5	2.4 ± 0.6	4.985	< 0.001
Constipation syndrome	2.0 ± 0.6	2.5 ± 0.7	4.257	< 0.001
Total score	10.1 ± 2.1	12.5 ± 2.4	5.896	< 0.001

Table 7 Comparison of postoperative recovery indicators between two groups (hours), mean ± SD

Indicator	Study group (n = 59)	Control group (n = 61)	t value	P value
Time to first flatus	16.8 ± 4.2	20.3 ± 5.6	3.893	< 0.001
Time to first defecation	28.5 ± 6.3	33.8 ± 7.9	4.055	< 0.001
Fasting time	30.2 ± 8.1	36.7 ± 9.5	4.06	< 0.001

Table 8 Comparison of European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 scores between two groups preoperatively and at 1 month postoperatively (points), mean ± SD

Item	Preop study (n = 59)	Preop control (n = 61)	Preop P	Postop study (n = 59)	Postop control (n = 61)	Postop P
Functional domains
Physical function	82.3 ± 9.5	83.1 ± 8.9	0.615	88.6 ± 7.2	83.4 ± 8.6	< 0.001
Role function	79.6 ± 10.2	80.3 ± 9.8	0.694	86.2 ± 8.1	80.7 ± 9.3	< 0.001
Emotional function	75.8 ± 11.3	76.4 ± 10.7	0.763	83.5 ± 8.6	78.2 ± 9.8	0.002
Cognitive function	81.2 ± 9.8	82.0 ± 9.3	0.640	86.7 ± 7.5	83.9 ± 8.9	0.063
Social function	77.4 ± 10.6	78.2 ± 10.1	0.667	84.8 ± 8.3	79.1 ± 9.6	< 0.001
Global health status/QoL	65.3 ± 12.4	66.1 ± 11.8	0.712	78.9 ± 9.2	70.5 ± 10.8	< 0.001
Symptom domains
Fatigue	28.6 ± 8.9	29.3 ± 8.5	0.652	18.3 ± 6.4	24.7 ± 7.8	< 0.001
Pain	22.4 ± 7.6	23.1 ± 7.2	0.606	12.5 ± 5.3	18.9 ± 6.7	< 0.001
Nausea and vomiting	15.2 ± 5.8	15.8 ± 5.6	0.561	8.6 ± 4.2	13.4 ± 5.6	< 0.001
Single items
Dyspnea	18.3 ± 6.5	18.9 ± 6.2	0.601	15.7 ± 5.8	17.2 ± 6.4	0.171
Insomnia	24.6 ± 8.2	25.3 ± 7.9	0.629	20.4 ± 7.1	22.8 ± 7.6	0.070
Appetite loss	20.8 ± 7.3	21.5 ± 7.0	0.589	14.2 ± 5.6	16.3 ± 6.2	0.052
Constipation	19.5 ± 6.8	20.1 ± 6.5	0.612	16.8 ± 5.9	19.7 ± 6.3	0.011
Diarrhea	16.7 ± 5.9	17.3 ± 5.7	0.570	13.5 ± 5.2	16.3 ± 5.8	0.007
Financial difficulties	22.3 ± 7.8	23.0 ± 7.5	0.612	19.6 ± 6.9	21.2 ± 7.3	0.206

QoL: Quality of life.