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NCT Number: NCT03754751

Enhanced Recovery in Laparoscopic Cholecystectomy

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

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Key information

Conditions

Acute Cholecystitis Biliary Tract Diseases Cholecystitis Cholecystitis, Acute Digestive System Diseases Gallbladder Diseases Gangrenous Cholecystitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taras Nechay

Moscow, 115569, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laparoscopic cholecystectomy with the implementation of modified ERAS program

Procedure

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

  • 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

Procedure

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

  • 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 outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. Postoperative pain

    Time frame: 24 hours

    Level of postoperative pain syndrome measured with a visual analog scale in centimeters

  4. 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

  5. Shoulder pain level

    Time frame: 24 hours

    Level of shoulder pain syndrome measured with a visual analog scale in centimeters

Sponsors and collaborators

Lead sponsor

Pirogov Russian National Research Medical University

Other

Registry information

Official study title

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

Acronym: ERLAC

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2018
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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