Enhanced Recovery in Laparoscopic Cholecystectomy

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 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

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