Randomized Controlled Trial
Copyright ©The Author(s) 2022.
World J Clin Cases. Nov 6, 2022; 10(31): 11427-11441
Published online Nov 6, 2022. doi: 10.12998/wjcc.v10.i31.11427
Table 1 Procedures in the intervention group and control group
Components
Intervention group
Control group
Preoperative stage
Counseling and patient educationPatients were educated regarding knowledge of the disease and perioperative cautions, and key points to achieve better cooperation. Same as the intervention group
Preoperative optimizationThe use of tobacco and alcohol was restricted; patients were instructed to perform efficient cough and back percussion and were required to perform activities (e.g., blow balloons or climb stairs) to improve lung function.
Preoperative nutritional careUsing the Nutritional Risk Screening score (NRS 2002) to assess nutritional risk. Patients at risk received oral nutritional supplements for 5–7 d prior to surgery.
Preoperative fasting and carbohydrate loadingFasting from solid foods for 6 h before surgery; 2–3 h before surgery, patients without diabetes received 200–350 mL of electrolyte drinks under the guidance of dietitians (ingredients: glucose 100 mmol/L, sodium 50 mmol, potassium 20 mmol/L, chloride 50 mmol/L, magnesium 1 mmol/L, phosphorus 2 mmol/L); water was prohibited during the 2 h before surgery.
Intraoperative stage
Optimization of anesthesiaMedium- and short-acting anesthetics were recommended.Same as the intervention group
Tube placementNasogastric tube, abdominal drainage tube or urinary catheter were selectively placed when indicated.
Prevention of intraoperative hypothermiaIntraoperative normothermia was maintained at 36 °C or over, using the following methods. The operating room temperature was set at 26 ℃–27 ℃ before surgery and 30 min before the end of the operation; during the operation, the temperature was set at 22 ℃–23 ℃, and the exposed area of the patient’s body was wrapped with a quilt. The skin antiseptic agent was heated to 40 ℃, and the rinse solution and intravenous infusion fluid were heated to 37 ℃.
Postoperative stage
Postoperative analgesiaMultimodal analgesia: Intravenous patient-controlled analgesia and NSAIDs. Same as the intervention group
Prevention of nausea and vomitingAntiemetics were appropriately administered to patients based on their number of risk factors.
Tube managementAvoidance or early removal of nasogastric tube, abdominal drainage tube or urinary catheter.
Postoperative early oral intakePatients were encouraged to drink when they were awake after the operation. If there was no discomfort, a liquid diet was allowed after the first postoperative flatus passage, and the semi flow and general diet were gradually recovered.
Postoperative nutritional care According to the NRS-2002, oral nutritional supplementation (or additional parenteral nutrition when indicated) was provided for malnourished patients.
Early mobilizationSix hours after recovering from anesthesia, the patients were restricted to the lateral or semi-recumbent position; the patients were allowed to turn over in the bed on the first day, move out of bed on the second day, and stand and walk around on the third day after the operation.
INTDisinfecting the bilateral acupoints LI-4, PC-6, LR-3, SP-4, ST-36, ST-37, and ST-39 with 75% medical alcohol. Removing the sealing paper from the press needle, then attaching the adhesive tape with press needle to the acupoints. Pressure was applied to the acupoints until the patients experienced local soreness, numbness, and/or pain. The patient or caregiver was instructed to press each acupoint for 2 min at 4–6 h intervals. The press needles were changed every 24 h. INT was performed immediately upon the patient's return to the ward after surgery and continued for seven consecutive days.The patients in the control group did not receive INT. However, adhesive tapes were attached at their corresponding acupoints with the same appearance as the adhesive tapes with needles applied to the acupoints of the patients in the intervention group.
Table 2 Demographic and clinical characteristics at baseline (n = 64)
Variable
mean ± SD or n (%)
t /x2
P value
Intervention group (n = 32)
Control group (n = 32)
Age (years)65 ± 9.361 ± 10.61.6960.10
Gender
Male18 (56.3)19 (59.4)0.0640.80
Female14 (43.8)13 (40.6)
Education level0.3090.86
Middle school or below12 (37.5)11 (34.4)
High school or junior college12 (37.5)11 (34)
Baccalaureate or above8 (25.0)10 (31.3)
Occupations13.4420.50
Farmer12 (37.5)12 (37.5)
Worker4 (12.5)2 (6.3)
Government official1 (3.1)5 (15.6)
Retiree12 (37.5)10 (31.3)
Other3 (9.4)3 (9.4)
Residence0.0001.00
Rural areas12 (37.5)12 (37.5)
Urban areas20 (62.5)20 (62.5)
Marital status10.4081.00
Married28 (87.5)27 (84.4)
Widowed2 (6.3)2 (6.3)
Divorced2 (6.3)3 (9.4)
Smoking0.0800.78
Yes8 (25.0)9 (28.1)
No24 (75.0)23 (71.9)
Drinking10.5540.83
Often8 (25.0)8 (25.0)
Occasionally18 (56.2)20 (62.5)
Never6 (18.8)4 (12.5)
Cancer types11.0590.64
Gastric cancer12 (37.5)16 (50.0)
Colon cancer14 (43.7)11 (34.4)
Rectal cancer6 (18.8)5 (15.6)
Pathological type10.750.71
Adenocarcinoma27 (84.4)29 (90.6)
Squamous cell carcinoma5 (15.6)3 (9.4)
Stages of disease10.8770.67
2 (6.3)1 (3.1)
21 (65.6)24 (75.0)
9 (28.1)7 (21.9)
Surgical approach0.5770.45
Traditional radical resection20 (62.5)17 (53.1)
Laparoscopy12 (37.5)15 (46.9)
Table 3 Intradermal needle therapy effect on postoperative functions
OutcomesGroupMerged
Subgroup
Gastric cancer
Colon cancer
n
mean ± SD
P value
n
mean ± SD
P value
n
mean ± SD
P value
Time to first flatus passage (h)Intervention group3266 ± 27< 0.0011283 ± 320.062056 ± 170.002
Control group32103 ± 4116110 ± 371697 ± 44
Time to first defecation (h)Intervention group32106 ± 44< 0.00112125 ± 360.092094 ± 440.001
Control group32153 ± 5016155 ± 4816150 ± 53
Time to first oral feeding (h)Intervention group3273 ± 30< 0.0011294 ± 300.02 2061 ± 22< 0.001
Control group32115 ± 3816126 ± 3516105 ± 40
Table 4 Comparison within and between groups for gastrointestinal symptoms
Measure
Intervention group (n = 32)
Control group (n = 32)
Between-group difference
Mean difference (95%CI)
P value
Mean difference (95%CI)
P value
Mean difference (95%CI)
P value
Abdominal distension
T1ReferenceN/AReferenceN/A-0.2 (-0.5, 0.1)0.26
T2-0.2 (-0.5, -0.2)0.720.5 (0.2, 0.7)<0.001-0.8 (-1.1, -0.5)< 0.001
T3-0.7 (-1.0, -0.4)< 0.0010.2 (-0.3, 0.6)0.97-1.0 (-1.3, -0.7)< 0.001
Nausea
T1ReferenceN/AReferenceN/A0.1 (-0.2, 0.5)0.46
T2-0.6 (-0.9, -0.6)< 0.001-0.1 (-0.4, 0.2)1.00-0.5 (-0.8, -0.3)< 0.001
T3-1.0 (-1.3, -0.8)< 0.001-0.6 (-1.0, -0.2)0.002-0.3 (-0.5, -0.2)< 0.001
Vomiting
T1ReferenceN/AReferenceN/A0 (-0.3, 0.3)0.83
T2-0.2 (-0.4, 0)0.02-0.1 (-0.2, 0.1)1.00-0.2 (-0.4, 0.1)0.19
T3-0.3 (-0.5, 0)0.02-0.3 (-0.5, 0)0.06-0.1 (-0.2, 0)0.14
Fatigue
T1ReferenceN/AReferenceN/A-0.3 (-0.7, 0)0.04
T2-0.8 (-1.0, -0.5)< 0.001-0.2 (-0.4, 0)0.13-0.9 (-1.2, -0.6)< 0.001
T3-1.1 (-1.4, -0.9)< 0.001-0.7 (-0.9, -0.5)< 0.001-0.8 (-1.1, -0.5)< 0.001
Table 5 Subgroup analysis for gastrointestinal symptoms
Subgroup/measureIntervention group
Control group
Between-group difference
Mean difference (95%CI)
P value
Mean difference (95%CI)
P value
Mean difference (95%CI)
P value
Abdominal distension
Gastric cancer (n = 28)T1ReferenceN/AReferenceN/A0 (-0.5, 0.5)1.00
T2-0.1 (-0.7, 0.5)1.000.4 (0.1, 0.8)0.01-0.5 (-1.0, 0)0.04
T3-0.7 (-1.3, -0.1)0.020.2 (-0.4, 0.8)1.00-0.9 (-1.3, -0.4)< 0.001
Colon cancer (n = 36)T1ReferenceN/AReferenceN/A-0.3 (-0.7, 0.1)0.17
T2-0.2 (-0.6, 0.2)0.560.5 (0.1, 0.9)0.003-1.0 (-1.4, -0.6)< 0.001
T3-0.7 (-1.0, -0.3)< 0.0010.2 (-0.5, 0.9)1.00-1.1 (-1.5, -0.7)< 0.001
Nausea
Gastric cancer (n = 28)T1ReferenceN/AReferenceN/A0.6 (0.1, 1.0)0.01
T2-0.9 (-1.1, -0.7)< 0.0010.2 (-0.2, 0.6)0.71-0.5 (-0.9, -0.1)0.009
T3-1.3 (-1.8, -0.9)< 0.001-0.4 (-0.9, 0.2)0.32-0.4 (-0.7, -0.1)0.01
Colon cancer (n = 36)T1ReferenceN/AReferenceN/A-0.2 (-0.7, 0.3)0.38
T2-0.9 (-1.2, -0.5)< 0.001-0.4 (-0.7, 0)0.04-0.5 (-0.8, -0.2)0.004
T3-0.7 (-0.9, -0.4)< 0.001-0.8 (-1.3, -0.2)0.003-0.3 (-0.5, -0.1)0.007
Vomiting
Gastric cancer (n = 28)T1ReferenceN/AReferenceN/A0.2 (-0.3, 0.7)0.43
T2-0.3 (-0.7, 0)0.040.1 (-0.2, 0.3)1.00-0.2 (-0.7, 0.2)0.35
T3-0.5 (-1.0, -0.1)0.02-0.2 (-0.6, 0.2)0.71-0.1 (-0.3, 0)0.13
Colon cancer (n = 36)T1ReferenceN/AReferenceN/A-0.2 (-0.5, 0.2)0.37
T2-0.1 (-0.3, 0.1)0.067-0.2 (-0.4, 0.1)0.10-0.1 (-0.3, 0.1)0.44
T3-0.2 (-0.4, 0.1)0.11-0.3 (-0.7, 0.1)0.150 (0, 0)1.00
Fatigue
Gastric cancer (n = 28)T1ReferenceN/AReferenceN/A-0.5 (-1.1, 0)0.06
T2-0.5 (-1.0, 0.1)0.07-0.1 (-0.5, 0.2)1.00-0.9 (-1.3, -0.5)< 0.001
T3-0.8 (-1.2, -0.5)< 0.001-0.8 (-1.1, -0.5)< 0.001-0.5 (-0.9, -0.2)0.003
Colon cancer (n = 36)T1ReferenceN/AReferenceN/A-0.3 (-0.7, 0.2)0.28
T2-0.9 (-1.2, -0.6)< 0.001-0.3 (-0.5, 0)0.06-0.9 (0.4, 1.4)< 0.001
T3-1.3 (-1.6, -1.0)< 0.001-0.6 (-0.9, -0.3)< 0.001-1.0 (-1.4, -0.6)< 0.001
Table 6 Parameter estimates of needle therapy effect on gastrointestinal symptoms
Measure
Parameters
B
95%CI lower
95%CI upper
P value
Abdominal distension(group = 1) × (time = 3)-0.8-1.3-0.4< 0.001
(group = 1) × (time = 2)-0.6-1.0-0.3< 0.001
Nausea(group = 1) × (time = 3)-0.5-0.9-0.10.02
(group = 1) × (time = 2)-0.7-0.9-0.40.001
Vomiting(group = 1) × (time = 3)0.1-0.30.30.83
(group = 1) × (time = 2)-0.1-0.30.10.22
Fatigue(group = 1) × (time = 3)-0.4-0.7-0.20.003
(group = 1) × (time = 2)-0.6-0.9-0.3< 0.001