The study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis.
Laparoscopic cholecystectomy (LC) is the most common surgical procedures in the world. Elective LC is commonly performed as one-day surgery, while in an emergency setting of acute cholecystitis the in-hospital stay averages 4.5 days. Causes of prolonged rehabilitation period are often associated with severe pain syndrome, dyspepsia and postoperative complications. The complications rate after LC is about 6% and has no tendency to decrease. The implementation of enhanced recovery after surgery (ERAS) programs may potentially reduce stress-associated complications and improve the quality of rehabilitation. A few retrospective studies examined their advantages and setbacks in the treatment of acute cholecystitis with encouraging results. The aim of this randomized control study is to evaluate the modified ERAS program for patients with acute cholecystitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
189
Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery. 1\) Patient informing and brochure Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia 1. Low-pressure pneumoperitoneum (8-9 mmHg) 2. Trocar wound and intraabdominal anesthesia with 0.25% ropivacaine 3. PONV prophylaxis in patients of risk Postoperative care 1. Early mobilization (2 h after surgery) 2. Early fluid intake (2 h after surgery) 3. Early liquid food (6 h after surgery) Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery
Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery. 1\) Patient oral informing. No brochure Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia 1. Standard CO2 pressure (12-14 mmHg) 2. No additional anesthesia Postoperative care 1. Mobilization in 4-6 h after surgery 2. Fluid intake in 6 hours 3. Liquid food intake in 12 hours Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery
Taras Nechay
Moscow, Russia
Postoperative length of stay (pLOS)
Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days
Time frame: 30 days
Complication rate
Number of patients who develop postoperative complications (surgical site infections, intraabdominal organ-specific infection, postoperative ileus) in relation to the total number of patients, measured in percentage
Time frame: 30 days
Readmission rate
Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage
Time frame: 30 days
Postoperative pain
Level of postoperative pain syndrome measured with a visual analog scale in centimeters
Time frame: 24 hours
Shoulder pain incidence
Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage
Time frame: 24 hours
Shoulder pain level
Level of shoulder pain syndrome measured with a visual analog scale in centimeters
Time frame: 24 hours
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