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Enhanced Recovery in Laparoscopic Cholecystectomy (ERLAC)

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ClinicalTrials.gov Identifier: NCT03754751
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : March 28, 2019
Sponsor:
Information provided by (Responsible Party):
Pirogov Russian National Research Medical University

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

Condition or disease Intervention/treatment Phase
Acute Cholecystitis Gangrenous Cholecystitis Procedure: Laparoscopic cholecystectomy with the implementation of modified ERAS program Procedure: Laparoscopic cholecystectomy with standard perioperative treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modified Enhanced Recovery Program in Patients With Acute Cholecystitis Undergoing Laparoscopic Cholecystectomy: Prospective Randomized Trial
Actual Study Start Date : January 31, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03754751


Contacts
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Contact: Taras Nechay, PhD +79268146829 tnechay@mail.ru

Locations
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Russian Federation
Taras Nechay Recruiting
Moscow, Russian Federation, 115569
Contact: Taras V Nechay, PhD    +79268146829    tnechay@mail.ru   
Contact: Yuri Balakirev    +79265711133    vertudo07@gmail.com   
Sponsors and Collaborators
Pirogov Russian National Research Medical University
Investigators
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Study Chair: Alexander Sazhin, Prof. Pirogov Russian National Research Medical University

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Responsible Party: Pirogov Russian National Research Medical University
ClinicalTrials.gov Identifier: NCT03754751     History of Changes
Other Study ID Numbers: ERLAC
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pirogov Russian National Research Medical University:
enhanced recovery
intraperitoneal anesthesia
low pressure pneumoperitoneum
cholecystitis
in-hospital stay
laparoscopic cholecystectomy

Additional relevant MeSH terms:
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Cholecystitis
Acalculous Cholecystitis
Cholecystitis, Acute
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases