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临床试验/NCT04078451
NCT04078451Unknown不适用

The Clinical Study of Laparoscopic Cholecystectomy With the Preservation of the Main Cystic Artery

Beijing Luhe Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年6月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
intraoperative blood loss

研究概览

简要总结

Prospectively selected 100 cases of patients who suffered from gallstones ro cholecystic polypus and treated with laparoscopic cholecystectomy in our hospital. Randomly divided into the experimental group and the control group. The experimental group preserve the main cystic artery, and the control group treated with conventional laparoscopic cholecystectomy. Collection of statistics: including general data(gender, age, BMI, etc.), time of surgery, intraoperative blood loss, incidence of surgical complications (delayed hemorrhage, biliary injury, etc.) and postoperative pain score, etc.

详细描述

  1. research object (1)patients who suffered from gallstones ro cholecystic polypus. (2)Informed and consented to participate in this clinical trial (3)Number of enrolled cases:100.(About 700 cases were treated in our hospital)
  2. Inclusion criteria

(1) consistent with the indications of cholecystectomy (2) no cholangitis or pancreatitis (3) no diabetes (4) the operation time is less than or equal to 1 hour 3.Exclusion criteria

  1. patients with acute cholecystitis
  2. cystic arterial variation causes related complications
  3. patients receiving analgesic drugs after surgery 4.research methods 4.1 Grouping method: random number table method was applied to randomly divide into 2 groups.

4.2 surgical method:Laparoscopic cholecystectomy with the preservation of the main cystic artery

  1. General anesthesia, use laryngeal mask
  2. making CO2 pneumoperitoneum through the superior border of umbilical pneumoperitoneum pressure 12 -- 14 mmHg(1 mmHg=0.(133 kPa), the puncture sleeve was placed under laparoscopy according to the three-hole method.
  3. To expose the gallbladder triangle, cut the serous membrane of the triangular region along the gallbladder tube, expose the neck and the left half of the gallbladder tube, push the rest tissue of the triangular region (including the main cystic artery, etc.) to the right, and separate the right half of the gallbladder tube, exposing the whole gallbladder tube.
  4. Cutting off after clipping the gallbladder tube;
  5. Turn up the gallbladder neck, cut off the superficial and deep branches of the gallbladder artery by electric hook along the gallbladder wall.
  6. Remove the gallbladder. through the umbilical hole and close the puncture hole. 4.3 main outcome measures

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • consistent with the indications of cholecystectomy
  • no cholangitis or pancreatitis
  • no diabetes
  • the operation time is less than or equal to 1 hour

排除标准

  • patients with acute cholecystitis
  • cystic arterial variation causes related complications
  • patients receiving analgesic drugs after surgery

结局指标

主要结局

intraoperative blood loss

时间窗: One hour to 24 hours after surgery

Compare the amount of blood loss during the two operations

Operation time

时间窗: One hour to 24 hours after surgery

Compare the operation time between the two operations

incidence of surgical complications

时间窗: One hour to 24 hours after surgery

delayed hemorrhage, biliary tract injury, etc.

次要结局

未报告次要终点

研究者

发起方
Beijing Luhe Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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