ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

Sponsor

Vitebsk State Medical University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04633382

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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".

Condition or Disease	Intervention/Treatment	Phase
Biliary Stricture Cholangiocarcinoma Cholangitis; Choledocholithiasis	Combination Product: Enhanced recovery after biliary tract surgery	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

JUSTIFICATION OF THE PRINCIPLES OF ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 31, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Conducting research of enhanced recovery after surgery 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 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 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 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

Arm

Intervention/Treatment

Experimental: Conducting research of enhanced recovery after surgery

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

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

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

Outcome Measures

Primary Outcome Measures

Reduction of bed-days [1 week]
Improvement of basic health indicators, absence of complications, reduction of bed days

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Vitebsk State Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yury Arlouski, Associate professor, MD, PhD, Vitebsk State Medical University

ClinicalTrials.gov Identifier:

NCT04633382

Other Study ID Numbers:

Biliary interventional

First Posted:

Nov 18, 2020

Last Update Posted:

Nov 19, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Yury Arlouski, Associate professor, MD, PhD, Vitebsk State Medical University

Fast track, Enhanced recovery after surgery, biliary surgery

Additional relevant MeSH terms:

Cholangiocarcinoma

Cholangitis

Choledocholithiasis

Study Results

No Results Posted as of Nov 19, 2020