Brief Title
Enhanced Recovery in Laparoscopic Cholecystectomy
Official Title
Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial
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.
Study Type
Interventional
Primary Outcome
Postoperative length of stay (pLOS)
Secondary Outcome
Complication rate
Condition
Acute Cholecystitis
Intervention
Laparoscopic cholecystectomy with the implementation of modified ERAS program
Study Arms / Comparison Groups
Modified ERAS program group
Description: Laparoscopic cholecystectomy with the implementation of modified ERAS program
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
189
Start Date
January 31, 2017
Completion Date
January 30, 2019
Primary Completion Date
January 1, 2019
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Alexander Sazhin, Prof., ,
Location Countries
Russian Federation
Location Countries
Russian Federation
Administrative Informations
NCT ID
NCT03754751
Organization ID
ERLAC
Responsible Party
Sponsor
Study Sponsor
Pirogov Russian National Research Medical University
Study Sponsor
Alexander Sazhin, Prof., Study Chair, Pirogov Russian National Research Medical University
Verification Date
November 2019