ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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JUSTIFICATION OF THE PRINCIPLES OF ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

Conditions
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Biliary Stricture, Cholangiocarcinoma, Cholangitis; Choledocholithiasis

Intervention / Treatment
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* Combination Product: Enhanced recovery after biliary tract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. 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: Scale ASA> III (severe concomitant cardiovascular pathology). Palliative reconstructive surgery. Previously performed operations on the bile ducts (up to 1 month). Cachexia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conducting research of enhanced recovery after surgery<br>Informing the patient about the course of the operation and the postoperative period. Psychological preparation. Refusal from complete starvation. Carbohydrate drink 2 hours before surgery. Refusal of cleansing enemas. Refusal of premedication. NSAIDs 30 minutes before surgery Prevention of thromboembolic complications Multimodal analgesia: epidural catheter, paracetamol. Minimally invasive access. Prevention of hypothermia Targeted infusion therapy. Failure or limited time use of drainages: gastric, intra-abdominal, bile duct drainage. Early activation of the patient. Early enteral nutrition. Prevention of nausea and vomiting. | Combination Product: Enhanced recovery after biliary tract surgery<br>* Patients with malignant and benign diseases of the bile ducts, who have formed various types of anastomosis in two options for managing the postoperative period: traditional and based on the principles of enhanced recovery after surgery<br>|
| Placebo Comparator: Conducting research of traditional recovery after surgery<br>Informing the patient about the course of the operation and the postoperative period. Psychological preparation. Fasting for 2 days Use of cleansing enemas. Bowel preparation Premedication Prevention of thromboembolic complications Without multimodal analgesia Traditional access. Prevention of hypothermia Targeted infusion therapy. Use of drains: gastric, intra-abdominal, bile duct drainage. Activation of patients within 2 days. Enteral nutrition after 2 days after surgery. Without the use of metoclopramide | Combination Product: Enhanced recovery after biliary tract surgery<br>* Patients with malignant and benign diseases of the bile ducts, who have formed various types of anastomosis in two options for managing the postoperative period: traditional and based on the principles of enhanced recovery after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of bed-days | Improvement of basic health indicators, absence of complications, reduction of bed days | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fast track, Enhanced recovery after surgery, biliary surgery