Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Cholecystitis
- Sponsor
- Pirogov Russian National Research Medical University
- Enrollment
- 189
- Locations
- 1
- Primary Endpoint
- Postoperative length of stay (pLOS)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Grade I and II acute cholecystitis according to Tokyo Guidelines 2013 classification (TG13)
- •ASA I and II.
Exclusion Criteria
- •Severe acute cholecystitis (Grade III on TG13);
- •Patient's refusal to participate;
- •The language barrier;
- •Transfer to the intensive care unit after surgery;
- •ASA class ≥ III;
- •Conversion to open procedure;
- •Biliary hypertension detected during preoperative examination or intraoperatively.
Outcomes
Primary Outcomes
Postoperative length of stay (pLOS)
Time Frame: 30 days
Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days
Secondary Outcomes
- Readmission rate(30 days)
- Shoulder pain incidence(24 hours)
- Complication rate(30 days)
- Postoperative pain(24 hours)
- Shoulder pain level(24 hours)