Enhanced Recovery in Laparoscopic Cholecystectomy (ERLAC)
Primary Purpose
Acute Cholecystitis, Gangrenous Cholecystitis
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Laparoscopic cholecystectomy with the implementation of modified ERAS program
Laparoscopic cholecystectomy with standard perioperative treatment
Sponsored by
About this trial
This is an interventional treatment trial for Acute Cholecystitis focused on measuring enhanced recovery, intraperitoneal anesthesia, low pressure pneumoperitoneum, cholecystitis, in-hospital stay, laparoscopic cholecystectomy
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.
Sites / Locations
- Taras Nechay
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Modified ERAS program group
Conventional care group
Arm Description
Laparoscopic cholecystectomy with the implementation of modified ERAS program
Laparoscopic cholecystectomy with standard perioperative treatment
Outcomes
Primary Outcome Measures
Postoperative length of stay (pLOS)
Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days
Secondary Outcome Measures
Complication rate
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
Readmission rate
Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage
Postoperative pain
Level of postoperative pain syndrome measured with a visual analog scale in centimeters
Shoulder pain incidence
Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage
Shoulder pain level
Level of shoulder pain syndrome measured with a visual analog scale in centimeters
Full Information
NCT ID
NCT03754751
First Posted
November 21, 2018
Last Updated
January 14, 2021
Sponsor
Pirogov Russian National Research Medical University
1. Study Identification
Unique Protocol Identification Number
NCT03754751
Brief Title
Enhanced Recovery in Laparoscopic Cholecystectomy
Acronym
ERLAC
Official Title
Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 31, 2017 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pirogov Russian National Research Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Cholecystitis, Gangrenous Cholecystitis
Keywords
enhanced recovery, intraperitoneal anesthesia, low pressure pneumoperitoneum, cholecystitis, in-hospital stay, laparoscopic cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Modified ERAS program group
Arm Type
Experimental
Arm Description
Laparoscopic cholecystectomy with the implementation of modified ERAS program
Arm Title
Conventional care group
Arm Type
Active Comparator
Arm Description
Laparoscopic cholecystectomy with standard perioperative treatment
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy with the implementation of modified ERAS program
Intervention Description
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
Low-pressure pneumoperitoneum (8-9 mmHg)
Trocar wound and intraabdominal anesthesia with 0.25% ropivacaine
PONV prophylaxis in patients of risk
Postoperative care
Early mobilization (2 h after surgery)
Early fluid intake (2 h after surgery)
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
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic cholecystectomy with standard perioperative treatment
Intervention Description
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
Standard CO2 pressure (12-14 mmHg)
No additional anesthesia
Postoperative care
Mobilization in 4-6 h after surgery
Fluid intake in 6 hours
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
Primary Outcome Measure Information:
Title
Postoperative length of stay (pLOS)
Description
Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Complication rate
Description
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
Time Frame
30 days
Title
Readmission rate
Description
Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage
Time Frame
30 days
Title
Postoperative pain
Description
Level of postoperative pain syndrome measured with a visual analog scale in centimeters
Time Frame
24 hours
Title
Shoulder pain incidence
Description
Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage
Time Frame
24 hours
Title
Shoulder pain level
Description
Level of shoulder pain syndrome measured with a visual analog scale in centimeters
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Sazhin, Prof.
Organizational Affiliation
Pirogov Russian National Research Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Taras Nechay
City
Moscow
ZIP/Postal Code
115569
Country
Russian Federation
12. IPD Sharing Statement
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Enhanced Recovery in Laparoscopic Cholecystectomy
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