Viewing Study NCT03754751


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Study NCT ID: NCT03754751
Status: COMPLETED
Last Update Posted: 2021-01-15
First Post: 2018-11-21
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Enhanced Recovery in Laparoscopic Cholecystectomy
Sponsor: Pirogov Russian National Research Medical University
Organization:

Study Overview

Official Title: Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial
Status: COMPLETED
Status Verified Date: 2019-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ERLAC
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 Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: