NCT03754751

Enhanced Recovery in Laparoscopic Cholecystectomy

Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Pirogov Russian National Research Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis.

Detailed description

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.

Conditions

• Acute Cholecystitis
• Gangrenous Cholecystitis

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic cholecystectomy with the implementation of modified ERAS program	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
PROCEDURE	Laparoscopic cholecystectomy with standard perioperative treatment	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

Timeline

• Start date: 2017-01-31
• Primary completion: 2019-01-01
• Completion: 2019-01-30
• First posted: 2018-11-27
• Last updated: 2021-01-15

Locations

1 site across 1 country: Russia