Effect of modified Da-Cheng-Qi decoction on stoma reversal and postoperative ileus after laparoscopic anterior resection

Table 1 Comparison of baseline data between two groups, n (%)

Item	Observation group (n = 132)	Control group (n = 151)	Statistic	P value
Age (years)	58.3 ± 10.6	59.1 ± 11.2	t = 0.596	0.552
Gender			χ2 = 0.428	0.513
Male	78 (59.1)	94 (62.3)
Female	54 (40.9)	57 (37.7)
BMI (kg/m2)	23.4 ± 2.8	23.7 ± 3.1	t = 0.827	0.409
Tumor location			χ2 = 2.156	0.54
Upper rectum	35 (26.5)	38 (25.2)
Middle rectum	42 (31.8)	55 (36.4)
Lower rectum	38 (28.8)	38 (25.2)
Lower sigmoid colon	17 (12.9)	20 (13.2)
TNM stage			χ2 = 0.894	0.64
Stage I	28 (21.2)	35 (23.2)
Stage II	52 (39.4)	63 (41.7)
Stage III	52 (39.4)	53 (35.1)
ASA grade			χ2 = 1.267	0.531
Grade I	38 (28.8)	48 (31.8)
Grade II	72 (54.5)	79 (52.3)
Grade III	22 (16.7)	24 (15.9)
Comorbidities
Hypertension	42 (31.8)	51 (33.8)	χ2 = 0.122	0.727
Diabetes	23 (17.4)	28 (18.5)	χ2 = 0.057	0.811
Coronary heart disease	15 (11.4)	19 (12.6)	χ2 = 0.106	0.745
Stoma type			χ2 = 0.015	0.904
Ileostomy	95 (72.0)	108 (71.5)
Colostomy	37 (28.0)	43 (28.5)

TNM: Tumor-nodes-metastasis; BMI: Body mass index; ASA: American Society of Anesthesiologists.

Table 2 Univariate Cox regression analysis of factors affecting stoma reversal time

Variable	HR	95%CI	P value
Age (≥ 60 years vs < 60 years)	0.823	0.662-1.024	0.082
Gender (female vs male)	1.085	0.872-1.350	0.467
BMI (≥ 24 kg/m2 vs < 24 kg/m2)	0.946	0.761-1.176	0.618
TNM stage	-	-	0.042
Stage I vs stage III	1.428	1.045-1.951	0.025
Stage II vs stage III	1.186	0.914-1.539	0.198
ASA grade (III vs I-II)	0.758	0.562-1.023	0.068
Tumor location	-	-	0.526
Hypertension (yes vs no)	0.892	0.703-1.131	0.345
Diabetes (yes vs no)	0.856	0.634-1.156	0.312
Stoma type (colostomy vs ileostomy)	1.124	0.876-1.442	0.358
Modified Da-Cheng-Qi Decoction (yes vs no)	2.235	1.738-2.875	< 0.001

TNM: Tumor-nodes-metastasis; BMI: Body mass index; ASA: American Society of Anesthesiologists; CI: Confidence interval; HR: Hazard ratio.

Table 3 Multivariate Cox regression analysis of factors affecting stoma reversal time

Variable	HR	95%CI	P value
Modified Da-Cheng-Qi Decoction (yes vs no)	2.147	1.658-2.781	< 0.001
TNM stage I (vs stage III)	1.523	1.082-2.145	0.016
TNM stage II (vs stage III)	1.248	0.956-1.629	0.104
Age (≥ 60 years vs < 60 years)	0.865	0.693-1.079	0.196
ASA grade (III vs I-II)	0.812	0.599-1.100	0.178

TNM: Tumor-nodes-metastasis; ASA: American Society of Anesthesiologists; CI: Confidence interval; HR: Hazard ratio.

Table 4 Comparison of postoperative ileus-related indicators and recovery indicators between two groups, n (%)

Indicator	Observation group (n = 132)	Control group (n = 151)	Statistic	P value
Postoperative ileus	8 (6.1)	28 (18.5)	χ2 = 10.245	0.001
Time to first anal gas passage (hours)	52.3 ± 10.8	68.7 ± 14.2	t = 11.01	< 0.001
Time to first defecation (hours)	78.6 ± 15.3	96.4 ± 18.7	t = 8.454	< 0.001
Time to bowel sound recovery (hours)	38.2 ± 8.5	51.6 ± 11.3	t = 10.963	< 0.001
Gastric tube retention time (days)	2.5 ± 0.6	3.0 ± 0.8	t = 5.741	< 0.001
Time to first oral liquid intake (days)	3.4 ± 0.7	4.3 ± 0.9	t = 9.120	< 0.001
Postoperative complications	12 (9.1)	18 (11.9)	χ2 = 0.668	0.414

Table 5 Comparison of postoperative complications between two groups, n (%)

Complication type	Observation group (n = 132)	Control group (n = 151)	χ2	P value
Wound infection	4 (3.0)	6 (4.0)	0.214	0.644
Pulmonary infection	3 (2.3)	5 (3.3)	0.285	0.594
Urinary tract infection	2 (1.5)	3 (2.0)	-	1.0001
Anastomotic bleeding	2 (1.5)	2 (1.3)	-	1.0001
Intestinal obstruction	1 (0.8)	2 (1.3)	-	1.0001
Total	12 (9.1)	18 (11.9)	0.668	0.414

¹Fisher’s exact test was used.

Table 6 Comparison of traditional Chinese medicine symptom scores between two groups (points)

Time point	Group	Abdominal distension	Abdominal pain	Nausea/vomiting	Poor appetite	Total score
Postoperative day 3	Observation	2.1 ± 0.6	1.8 ± 0.5	1.6 ± 0.5	1.9 ± 0.5	7.4 ± 1.5
	Control	2.2 ± 0.6	1.9 ± 0.6	1.7 ± 0.6	2.0 ± 0.6	7.8 ± 1.7
	t value	1.386	1.491	1.496	1.5	2.033
	P value	0.167	0.137	0.136	0.135	0.043
	Corrected P value	> 0.017	> 0.017	> 0.017	> 0.017	> 0.017
Postoperative day 5	Observation	1.2 ± 0.4	0.9 ± 0.4	0.7 ± 0.3	1.1 ± 0.4	3.9 ± 1.0
	Control	1.8 ± 0.5	1.4 ± 0.5	1.3 ± 0.5	1.6 ± 0.5	6.1 ± 1.4
	t value	10.713	9.109	11.572	9.086	14.679
	P value	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001
	Corrected P value	< 0.017	< 0.017	< 0.017	< 0.017	< 0.017
Postoperative day 7	Observation	0.6 ± 0.3	0.4 ± 0.3	0.3 ± 0.2	0.5 ± 0.3	1.8 ± 0.7
	Control	1.3 ± 0.5	0.9 ± 0.4	0.8 ± 0.4	1.0 ± 0.4	4.0 ± 1.1
	t value	13.929	11.729	12.818	11.729	19.39
	P value	< 0.001	< 0.001	< 0.001	< 0.001	< 0.001
	Corrected P value	< 0.017	< 0.017	< 0.017	< 0.017	< 0.017

Table 7 Comparison of global health status in quality of life at 3 months after stoma surgery between two groups (points)

Group	n	Global health status	t	P value
Observation group	132	68.5 ± 11.7	4.19	< 0.001
Control group	151	62.3 ± 13.2

Table 8 Comparison of stoma-related indicators between two groups, n (%)

Indicator	Observation group (n = 132)	Control group (n = 151)	Statistic	P value
Stoma complications	15 (11.4)	20 (13.2)	χ2 = 0.165	0.685
Parastomal hernia	5 (3.8)	7 (4.6)	-	-
Stoma prolapse	4 (3.0)	6 (4.0)	-	-
Stoma retraction	3 (2.3)	4 (2.6)	-	-
Peristomal dermatitis	3 (2.3)	3 (2.0)	-	-
Stoma reversal operation time (minute)	125.3 ± 28.6	136.8 ± 32.4	t = 3.134	0.002
Postoperative complications after stoma reversal	6 (4.5)	10 (6.6)	χ2 = 0.596	0.44
Wound infection	3 (2.3)	5 (3.3)	-	-
Intestinal obstruction	2 (1.5)	3 (2.0)	-	-
Anastomotic leakage	1 (0.8)	2 (1.3)	-	-

Table 9 Comparison of inflammatory and nutritional indicators between two groups

Indicator	Time point	Observation group (n = 132)	Control group (n = 151)	t value	P value	Corrected P value
WBC (× 109/L)	Preoperative day 1	6.8 ± 1.5	6.9 ± 1.6	0.529	0.597	-
	Postoperative day 3	10.2 ± 2.3	10.6 ± 2.5	1.385	0.167	> 0.017
	Postoperative day 5	8.5 ± 1.8	8.9 ± 2.0	1.737	0.084	> 0.017
	Postoperative day 7	7.3 ± 1.6	7.6 ± 1.7	1.519	0.13	> 0.017
CRP (mg/L)	Preoperative day 1	5.2 ± 2.1	5.4 ± 2.3	0.759	0.449	-
	Postoperative day 3	78.6 ± 18.4	82.3 ± 19.7	1.609	0.109	> 0.017
	Postoperative day 5	42.3 ± 12.5	48.7 ± 14.3	3.916	< 0.001	< 0.017
	Postoperative day 7	18.5 ± 6.8	22.4 ± 8.2	4.282	< 0.001	< 0.017
PCT (ng/mL)	Preoperative day 1	0.08 ± 0.03	0.08 ± 0.03	0	1	-
	Postoperative day 3	0.35 ± 0.12	0.37 ± 0.13	1.326	0.186	> 0.017
	Postoperative day 5	0.18 ± 0.08	0.21 ± 0.09	2.914	0.004	< 0.017
	Postoperative day 7	0.11 ± 0.05	0.13 ± 0.06	3.007	0.003	< 0.017
ALB (g/L)	Preoperative day 1	41.2 ± 3.8	40.8 ± 4.1	0.847	0.398	-
	Postoperative day 3	35.6 ± 3.2	35.2 ± 3.5	0.992	0.322	> 0.017
	Postoperative day 5	37.8 ± 3.1	36.5 ± 3.4	3.343	0.001	< 0.017
	Postoperative day 7	39.5 ± 3.0	38.2 ± 3.3	3.447	0.001	< 0.017
PA (mg/L)	Preoperative day 1	268.5 ± 42.3	265.2 ± 45.7	0.63	0.529	-
	Postoperative day 3	185.3 ± 35.6	182.7 ± 38.2	0.595	0.552	> 0.017
	Postoperative day 5	218.6 ± 32.4	205.3 ± 36.8	3.179	0.002	< 0.017
	Postoperative day 7	245.8 ± 31.5	228.4 ± 38.6	4.089	< 0.001	< 0.017
Hb (g/L)	Preoperative day 1	128.5 ± 15.6	127.3 ± 16.8	0.617	0.538	-
	Postoperative day 3	112.3 ± 12.4	111.5 ± 13.2	0.52	0.603	> 0.017
	Postoperative day 5	115.7 ± 11.8	113.8 ± 12.5	1.309	0.192	> 0.017
	Postoperative day 7	120.4 ± 11.3	118.6 ± 12.1	1.286	0.2	> 0.017

CRP: C-Reactive Protein; PCT: Procalcitonin; ALB: Albumin; PA: Prealbumin; Hb: Hemoglobin.

Table 10 Comparison of gastrointestinal hormone levels between two groups (pg/mL)

Indicator	Time point	Observation group (n = 132)	Control group (n = 151)	t value	P value	Corrected P value
MTL	Preoperative day 1	285.6 ± 42.3	282.4 ± 45.8	0.608	0.544	-
	Postoperative day 3	198.5 ± 35.7	195.2 ± 38.4	0.746	0.456	> 0.017
	Postoperative day 5	245.8 ± 38.6	218.3 ± 42.5	5.641	< 0.001	< 0.017
	Postoperative day 7	265.4 ± 39.8	238.7 ± 44.2	5.328	< 0.001	< 0.017
GAS	Preoperative day 1	92.5 ± 18.6	90.8 ± 19.7	0.743	0.458	-
	Postoperative day 3	68.3 ± 15.2	64.5 ± 16.8	1.985	0.048	> 0.017
	Postoperative day 5	82.6 ± 16.4	72.8 ± 17.9	4.799	< 0.001	< 0.017
	Postoperative day 7	87.5 ± 16.9	76.2 ± 18.3	5.421	< 0.001	< 0.017
VIP	Preoperative day 1	48.3 ± 10.5	49.1 ± 11.2	0.622	0.534	-
	Postoperative day 3	72.5 ± 14.8	74.2 ± 15.6	0.94	0.348	> 0.017
	Postoperative day 5	58.6 ± 12.3	66.8 ± 14.5	5.022	< 0.001	< 0.017
	Postoperative day 7	52.8 ± 11.4	60.5 ± 13.8	5.035	< 0.001	< 0.017

Normal reference ranges: Motilin 200-400 pg/mL, gastrin 40-150 pg/mL, vasoactive intestinal peptide 20-80 pg/mL. MTL: Motilin; GAS: Gastrin; VIP: Vasoactive intestinal peptide.