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The study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified ERAS program group | Experimental | Laparoscopic cholecystectomy with the implementation of modified ERAS program |
|
| Conventional care group | Active Comparator | Laparoscopic cholecystectomy with standard perioperative treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic cholecystectomy with the implementation of modified ERAS program | Procedure | 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
Postoperative care
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Readmission rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Sazhin, Prof. | Pirogov Russian National Research Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taras Nechay | Moscow | 115569 | Russia |
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| ID | Term |
|---|---|
| D041881 | Cholecystitis, Acute |
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D005705 | Gallbladder Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D017081 | Cholecystectomy, Laparoscopic |
| ID | Term |
|---|---|
| D002763 | Cholecystectomy |
| D001662 | Biliary Tract Surgical Procedures |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| Laparoscopic cholecystectomy with standard perioperative treatment | Procedure | 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
Postoperative care
|
|
Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage |
| 30 days |
| Postoperative pain | Level of postoperative pain syndrome measured with a visual analog scale in centimeters | 24 hours |
| 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 |
| Shoulder pain level | Level of shoulder pain syndrome measured with a visual analog scale in centimeters | 24 hours |
| D010535 | Laparoscopy |
| D004724 | Endoscopy |
| D019060 | Minimally Invasive Surgical Procedures |