Enhanced Recovery in Laparoscopic Cholecystectomy

Acute Cholecystitis Clinical Trial

— ERLAC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03754751
• Other study ID #: ERLAC
• Status: Completed
• Phase: N/A
• Start date: January 31, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: November 2019
• Source: Pirogov Russian National Research Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 189
• Est. completion date: January 30, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Cholecystitis
• Cholecystitis
• Cholecystitis, Acute
• Gangrenous Cholecystitis

Intervention

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 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
• 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 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

Locations

Country	Name	City	State
Russian Federation	Taras Nechay	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days
Secondary	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	30 days
Secondary	Readmission rate	Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage	30 days
Secondary	Postoperative pain	Level of postoperative pain syndrome measured with a visual analog scale in centimeters	24 hours
Secondary	Shoulder pain incidence	Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage	24 hours
Secondary	Shoulder pain level	Level of shoulder pain syndrome measured with a visual analog scale in centimeters	24 hours