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Enhanced Recovery in Laparoscopic Cholecystectomy

NCT03754751 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 189

Last updated 2021-01-15

No results posted yet for this study

Summary

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

Conditions

  • Acute Cholecystitis
  • Gangrenous Cholecystitis

Interventions

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

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

Sponsors & Collaborators

  • Pirogov Russian National Research Medical University

    lead OTHER

Principal Investigators

  • Alexander Sazhin, Prof. · Pirogov Russian National Research Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2019-01-01
Completion
2019-01-30

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03754751 on ClinicalTrials.gov