ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

November 17, 2020 updated by: Yury Arlouski, Vitebsk State Medical University

JUSTIFICATION OF THE PRINCIPLES OF ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

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".

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conducting research of enhanced recovery after surgery
  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.
Combination product: Enhanced recovery after biliary tract surgery
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
Placebo Comparator: Conducting research of traditional recovery after surgery
  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
Combination product: Enhanced recovery after biliary tract surgery
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitebsk State Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2021

Primary Completion (Anticipated)

January 31, 2021

Study Completion (Anticipated)

January 1, 2022

Study Registration Dates

First Submitted

November 12, 2020

First Submitted That Met QC Criteria

November 12, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 19, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Biliary interventional

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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