ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY

NCT ID: NCT04633382

Last Updated: 2020-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-01-01

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.

Conditions

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Biliary Stricture Cholangiocarcinoma Cholangitis; Choledocholithiasis

Keywords

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Fast track, Enhanced recovery after surgery, biliary surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Enhanced recovery after biliary tract surgery

Intervention Type COMBINATION_PRODUCT

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

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

Group Type PLACEBO_COMPARATOR

Enhanced recovery after biliary tract surgery

Intervention Type COMBINATION_PRODUCT

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

Interventions

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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

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vitebsk State Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yury Arlouski

Associate professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Yury N Arlouski, MD

Role: CONTACT

Phone: +375296374668

Email: [email protected]

Other Identifiers

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Biliary interventional

Identifier Type: -

Identifier Source: org_study_id