JUSTIFICATION OF THE PRINCIPLES OF ENHANCED RECOVERY AFTER BILIARY TRACT SURGERY
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 主要终点
- Reduction of bed-days
研究概览
简要总结
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".
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malignant diseases of the biliary tract (cholangiocarcinoma):
- •tumor resectability 1.
- •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.
- •Planned reconstructive surgery on the biliary tract.
- •Patients with benign biliary tract pathology. 2.
- •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
排除标准
- •Scale ASA> III (severe concomitant cardiovascular pathology).
- •Palliative reconstructive surgery.
- •Previously performed operations on the bile ducts (up to 1 month).
研究组 & 干预措施
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.
干预措施: Enhanced recovery after biliary tract surgery (Combination Product)
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
干预措施: Enhanced recovery after biliary tract surgery (Combination Product)
结局指标
主要结局
Reduction of bed-days
时间窗: 1 week
Improvement of basic health indicators, absence of complications, reduction of bed days
次要结局
未报告次要终点
研究者
Yury Arlouski
Associate professor, MD, PhD
Vitebsk State Medical University