ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

Vitebsk State Medical University

Status: Unknown

Conditions: Cholangitis; Choledocholithiasis; Cholangiocarcinoma; Biliary Stricture

Treatments: Combination Product: Enhanced recovery after biliary tract surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04633382

Biliary interventional

Details and patient eligibility

About

The aim of the study is to improve the immediate results after reconstructive and restorative operations on the biliary tract by substantiating the management of the perioperative period on the principles of "enhanced recovery after surgery".

Full description

A prospective randomized study on the effect of fast-track surgery on the immediate postoperative results after various reconstructive and restorative operations on the bile ducts. In the Department of Surgical Hepatology and Transplantation, a prospective randomized study will include patients (about 50) with planned reconstructive and restorative operations on the bile ducts for malignant and benign diseases of the bile ducts.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with malignant diseases of the biliary tract (cholangiocarcinoma):

   1.1. tumor resectability 1.2. absence:

   • distant metastases
   • carcinomatosis
   • perforation of the tumor and peritonitis
   • sprouting into adjacent organs and tissues (locally advanced cancer)
   • total adhesion process in the abdominal cavity (after previous operations). 1.3. Planned reconstructive surgery on the biliary tract.

2. Patients with benign biliary tract pathology. 2.1. Planned reconstructive or restorative surgery on the biliary tract for the following diseases:

   • choledocholithiasis
   • Mirizzi syndrome
   • cysts of the common bile duct
   • strictures of the common bile duct
   • injuries to the bile ducts
   • adenoma and stricture of the OBD

Exclusion criteria

1. Scale ASA> III (severe concomitant cardiovascular pathology).
2. Palliative reconstructive surgery.
3. Previously performed operations on the bile ducts (up to 1 month).
4. Cachexia.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Conducting research of enhanced recovery after surgery

Experimental group

Description:

1. Informing the patient about the course of the operation and the postoperative period. Psychological preparation. 2. Refusal from complete starvation. Carbohydrate drink 2 hours before surgery. 3. Refusal of cleansing enemas. 4. Refusal of premedication. NSAIDs 30 minutes before surgery 5. Prevention of thromboembolic complications 6. Multimodal analgesia: epidural catheter, paracetamol. 7. Minimally invasive access. 8. Prevention of hypothermia 9. Targeted infusion therapy. 10. Failure or limited time use of drainages: gastric, intra-abdominal, bile duct drainage. 11. Early activation of the patient. 12. Early enteral nutrition. 13. Prevention of nausea and vomiting.

Treatment:

Combination Product: Enhanced recovery after biliary tract surgery

Conducting research of traditional recovery after surgery

Placebo Comparator group

Description:

1. Informing the patient about the course of the operation and the postoperative period. Psychological preparation. 2. Fasting for 2 days 3. Use of cleansing enemas. Bowel preparation 4. Premedication 5. Prevention of thromboembolic complications 6. Without multimodal analgesia 7. Traditional access. 8. Prevention of hypothermia 9. Targeted infusion therapy. 10. Use of drains: gastric, intra-abdominal, bile duct drainage. 11. Activation of patients within 2 days. 12. Enteral nutrition after 2 days after surgery. 13. Without the use of metoclopramide

Treatment:

Combination Product: Enhanced recovery after biliary tract surgery