Enhanced Recovery in Laparoscopic Cholecystectomy (ERLAC)

Pirogov Russian National Research Medical University

Status

Completed

Conditions

Gangrenous Cholecystitis

Acute Cholecystitis

Treatments

Procedure: Laparoscopic cholecystectomy with standard perioperative treatment

Procedure: Laparoscopic cholecystectomy with the implementation of modified ERAS program

Study type

Interventional

Funder types

Other

Identifiers

NCT03754751

ERLAC

Details and patient eligibility

About

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

Full 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.

Enrollment

189 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.