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ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

Primary Purpose

Biliary Stricture, Cholangiocarcinoma, Cholangitis; Choledocholithiasis

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Enhanced recovery after biliary tract surgery
Sponsored by
Vitebsk State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Stricture focused on measuring Fast track, Enhanced recovery after surgery, biliary surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Conducting research of enhanced recovery after surgery

    Conducting research of traditional recovery after surgery

    Arm Description

    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.

    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

    Outcomes

    Primary Outcome Measures

    Reduction of bed-days
    Improvement of basic health indicators, absence of complications, reduction of bed days

    Secondary Outcome Measures

    Full Information

    First Posted
    November 12, 2020
    Last Updated
    November 17, 2020
    Sponsor
    Vitebsk State Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04633382
    Brief Title
    ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY
    Official Title
    JUSTIFICATION OF THE PRINCIPLES OF ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 1, 2021 (Anticipated)
    Primary Completion Date
    January 31, 2021 (Anticipated)
    Study Completion Date
    January 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Vitebsk State Medical University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Biliary Stricture, Cholangiocarcinoma, Cholangitis; Choledocholithiasis
    Keywords
    Fast track, Enhanced recovery after surgery, biliary surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Conducting research of enhanced recovery after surgery
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Conducting research of traditional recovery after surgery
    Arm Type
    Placebo Comparator
    Arm Description
    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
    Intervention Type
    Combination Product
    Intervention Name(s)
    Enhanced recovery after biliary tract surgery
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Reduction of bed-days
    Description
    Improvement of basic health indicators, absence of complications, reduction of bed days
    Time Frame
    1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yury N Arlouski, MD
    Phone
    +375296374668
    Email
    orl_doc@hotmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

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