Enhanced Recovery in Laparoscopic Cholecystectomy

NACompletedINTERVENTIONAL
Enrollment

189

Participants

Timeline

Start Date

January 31, 2017

Primary Completion Date

January 1, 2019

Study Completion Date

January 30, 2019

Conditions
Acute CholecystitisGangrenous 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"

Trial Locations (1)

115569

Taras Nechay, Moscow

All Listed Sponsors
lead

Pirogov Russian National Research Medical University

OTHER

NCT03754751 - Enhanced Recovery in Laparoscopic Cholecystectomy | Biotech Hunter | Biotech Hunter