Enhanced Recovery in Laparoscopic Cholecystectomy (ERLAC)

January 14, 2021 updated by: Pirogov Russian National Research Medical University

Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

189

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified ERAS program group
Laparoscopic cholecystectomy with the implementation of modified ERAS program
Procedure: Laparoscopic cholecystectomy with the implementation of modified ERAS program

Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.

1) Patient informing and brochure

Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia

  1. Low-pressure pneumoperitoneum (8-9 mmHg)
  2. Trocar wound and intraabdominal anesthesia with 0.25% ropivacaine
  3. PONV prophylaxis in patients of risk

Postoperative care

  1. Early mobilization (2 h after surgery)
  2. Early fluid intake (2 h after surgery)
  3. Early liquid food (6 h after surgery) Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery
Active Comparator: Conventional care group
Laparoscopic cholecystectomy with standard perioperative treatment
Procedure: Laparoscopic cholecystectomy with standard perioperative treatment

Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.

1) Patient oral informing. No brochure

Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia

  1. Standard CO2 pressure (12-14 mmHg)
  2. No additional anesthesia

Postoperative care

  1. Mobilization in 4-6 h after surgery
  2. Fluid intake in 6 hours
  3. Liquid food intake in 12 hours Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality "on demand": Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 30 days
Number of patients who develop postoperative complications (surgical site infections, intraabdominal organ-specific infection, postoperative ileus) in relation to the total number of patients, measured in percentage
30 days
Readmission rate
Time Frame: 30 days
Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage
30 days
Postoperative pain
Time Frame: 24 hours
Level of postoperative pain syndrome measured with a visual analog scale in centimeters
24 hours
Shoulder pain incidence
Time Frame: 24 hours
Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage
24 hours
Shoulder pain level
Time Frame: 24 hours
Level of shoulder pain syndrome measured with a visual analog scale in centimeters
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pirogov Russian National Research Medical University

Investigators

  • Study Chair: Alexander Sazhin, Prof., Pirogov Russian National Research Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2017

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 30, 2019

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERLAC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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