Participants and recruitment
Randomly classified clinical data on 70 patients (ERAS group) treated under the ERAS concept following LC at The People's Hospital of Fengqing from July 2020 to March 2021, and 70 patients (traditional group) who were treated under the traditional care concept at the hospital during the same period (Fig 1).
Inclusion criteria
(1) Patients diagnosed with chronic cholecystitis and proposed to undergo laparoscopic cholecystectomy; (2) age 18-75 years old, regardless of sex; (3) ASA score 1-2 points; (4) no history of abdominal surgery (5) no chronic liver and kidney diseases; (6) informed consent of patients was obtained.
Case exclusion criteria
(1) Age <18 years old or >75 years old; (2) a previous history of upper abdominal surgery that affects recovery; (3) the need for joint organ removal; (4) severe mental illness; diabetes, poor blood sugar control; severe emphysema, interstitial pneumonia or ischemic heart disease; (5) pregnancy or lactation; (6) patients or family members that cannot comprehend the condition and the purpose of this study
Exit criteria
(1) intraoperative and postoperative confirmation as a gallbladder malignancy; (2) Intraoperative joint organ removal or intraoperative conversion to open surgery conducted after selection for the study due to a combination of acute inflammation and emergency surgery; (3) withdrawal from the research study due to various reasons; (4) inability to complete the study plan due to various reasons.
Clinical pathways
Three-hole LC was performed on both groups of patients, but the perioperative procedures of treatment followed were different. The ERAS team made a series of optimizations and adjustments in preoperative, intraoperative and postoperative treatment measures based on the latest China Expert Consensus and Guidelines for Accelerated Rehabilitation Surgery (Table 1). The development and implementation of the program required multidisciplinary collaboration between surgeons, caregivers, anesthesiologists, pharmacists, operating room staff, clinics and pre-hospital service personnel.
Preoperative care
The preoperative care of the traditional care group included routine mission, routine preoperative non-smoking alcohol prohibition, the prohibition of eating for 12 hours, and the prohibition of drinking for 6 hours. Alternatively, the ERAS group was provided with ERAS concept education, preoperative nutrition assessment and nutritional support, prohibition of eating 6 hours prior to the operation, prohibition of drinking 2 hours prior to the operation, and 250 ml of oral 5% GS (Glucose)was administered 2 h before the surgery. Both groups were given prophylactic antibiotics, without urethra retention and without intestinal preparation.
Intraoperative care
Both groups of patients were administered general anesthesia through tracheal intubation and the same surgical method, three-hole LC was performed. Patients in the ERAS group were treated with Near- zero fluid balance(target-oriented fluid therapy), insurgence during surgery, without placing a drainage tube, and the wound was treated with 10 ml of 0.5% Bupivacaine, a local immersion anesthetic. Rehydration was not strictly controlled and there was no insulation during surgery for patients in the traditional treatment group.
Table 1 Two groups of perioperative period treatment
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ERAS group
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Traditional control group
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Preoperative
|
|
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Preoperative mission
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Conduct ERAS concept mission
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General mission
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Quit smoking and alcohol before surgery
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Yes
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Preoperative Nutrition Assessment and Nutritional Support
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NSR2002 Nutritional Risk > 3 lines of nutritional support
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Not
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Fasting Time
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Fast for 6 hours, drink 2h, take 2h orally 5% GS 250ml before surgery
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Regular fasting 12h, fasting 6h
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Leave the urethra
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Not
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Intestinal preparation
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Not
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Preventive antibiotics
|
Yes
|
in surgery
|
|
|
Anaesthetic
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Tracheal intubation general anaesthetic
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Liquid management
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Near- zero fluid balance(target-oriented fluid therapy).
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No, rehydration is not strictly controlled
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The way of surgery
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Three-hole method LC
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Keep warm during surgery
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Keep warm during surgery
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No, keep warm during non-operation
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Drainage tube
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Do not place the drainage tube
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Place the drainage as appropriate
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Wound treatment
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0.5% Bupivacaine 10ml partial immersion anaesthetic
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No special treatment
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After surgery
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|
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Stop gagging
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Preventive intravenous drop 5-HT3 receptor antagonists on the day after surgery
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No special treatment
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relieve pain
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Regular use of oral/intravenous NSAID painkillers
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If, VAS >3, give pain relief to the disease
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Eat early
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Encourage early eating, oral fluids as soon as the patient is lucid after surgery and solids after 4 h.
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No, give a fluid diet after exhaust
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Early activities
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Encourage early bed-out activities, 30 min on the day of surgery and 6 h/day thereafter
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No, as the patient wishes
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Postoperative
Patients in the ERAS group were provided with postoperative vomiting and nausea (POVN) prevention care. Patients were provided preventive intravenous dropped 5-HT3 receptor antagonists anti-spitting drugs and routinely used oral/intravenous NSAID painkillers on the day after surgery. Patients were encouraged to eat early, start on a fluid diet 6 h after surgery and a half-stream diet 1-2 days after surgery. Patients in the traditional care group didn’t receive any special POVN treatment. If the patient had a VAS >3, pain relief was provided. The patients were given a fluid diet if they were exhausted.
Observe the indicator
(1) Preoperative observation indicators: BMI for patients, anaesthetic risk ASA score, diagnosis of the disease, liver function (albumin, glutamate transaminase AST, glutamate transaminase ALT total bilirubin, direct bilirubin, indirect bilirubin).
(2) Postoperative observation index: postoperative hospital stay (days), total hospital stay time (days), surgery time (minutes), vas-score on the first day after surgery, first exhaust time (hours), first half-stream time (days), complications, mortality, hospitalization costs.
Discharge criteria
(1) Stable vital signs;
(2) Oral half-stream diet, no nausea, vomiting and other symptoms;
(3) Oral painkillers, VAS score < 2 points
(4) Ability to get out of bed
Follow-up
Both groups were followed up for 7 - 30 days after surgery. Postoperative complications, readmission rate and the re-surgery rate were recorded.
Outcome measure
The main outcome measured in this study was the length of hospital stay after surgery, which was measured from the beginning of surgery until the patient was discharged. The secondary outcomes measured the cost of hospitalization and VAS scores for postoperative pain, first exhaust time, and first half-flow time after surgery.
Statistical analysis
Based on a previous study[23], SPSS 19.0 software was used to determine the mean (group A, 4.5; group B, 5.5; SD=2; sampling ratio, 1; α, 0.05; β, 0.2) The total number of cases required was 128, and the study included a total of 140 patients, including 70 patients in the ERAS group and 70 in the regular control group, based on a 5-10% rate of missed visits.
Measurements are presented as ( ± s ). t-tests and count data usage rates were determined. Comparisons between the two groups were made using χ2 tests. P<0.05 was considered to indicate statistical significance.