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临床试验/NCT04368611
NCT04368611已完成不适用

Emergency Laparoscopic Cholecystectomy With Low Pressure Pneumo-peritoneum in Cardiopulmonary Risk Patients: Fundus First Cholecystectomy VS Calot First Cholecystectomy .Randomized Controlled Trials.

Zagazig University3 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
2
试验地点
3
主要终点
duration of operation in minutes

研究概览

简要总结

Introduction:

Laparoscopic cholecystectomy is the usual approach in dealing with cholithiasis that greatly replace open approach even in acute emergency gall bladder diseases. Laparoscopic approach has great advantages than open approach but the biliary injuries are higher in laparoscopic approach than open approach. Laparoscopic approach is condemned for many years in cardiopulmonary risk patients because of its adverse impacts on cardiopulmonary systems. Performing laparoscopic cholecystectomy with low pressure pneumoperitoneum may be effective in treatment of acute gall bladder disease but with fundus first approach than classical Calot first approach.

Aim: compare between initial Fundus first cholecystectomy followed by Calot dissection VS Calot only cholecystectomy in Emergency laparoscopic cholecystectomy with low pressure pneumo-peritoneum in cardiopulmonary risk patients as regard intraoperative data and postoperative complications.

Patients and methods:

This study prospective randomized controlled study was conducted on 470 cases with acute cholecystitis, biliary colic, mucocele and pyocele of gall bladder in emergency general surgery department. Patients were divided into 2 groups, Group A: fundus first group (235cases) and Group B (235cases): classical Calot first approach.

详细描述

  1. INTRODUCTION Introduction of laparoscopy in management of cholithiasis gave a great push to dealing with this disease. The advancement of laparoscopic cholecystectomy had greatly evolved in the last years making laparoscopic cholecystectomy is the commonest operation performed within field of gastrointestinal tract surgery and almost replaced open cholecystectomy.[1] [2]

After introduction of laparoscopic cholecystectomy, many advantages the patients gained over open cholecystectomy as small operative wounds with minimal postoperative pain and infection and hence rapid discharge from hospital. Other advantages are better cosmosis, earlier resumption of oral feeding and rapid restoration of daily activity and work. [3]

Although laparoscopic cholecystectomy had many advantages over open approach yet, many disadvantages emerged after the wide spread use of laparoscopic cholecystectomy as higher incidence of bile duct injuries that may reach 0.3-0.8% that may increase in acute emergent cases. This is a grave problem that may cause mortality to the patients. [4]Strasberg gave us the best solution up till now and the way to avoid injury to biliary tract. [5].Other complications the patients may face after laparoscopic cholecystectomy are organ injury; vascular injury and obstructive jaundice from missed stone in common bile duct during the operation. [6]

About 30% of patients undergo laparoscopic cholecystectomy are elderly patients with cardiopulmonary risks [7]

Co2 insufflation into the peritoneal cavity exerts bad effects on cardiac and respiratory systems and may worsen the condition of cardio-pulmonary risk patients. Pneumo-peritoneum with CO2 causes splintage of the diaphragm, hypercarbia with arrhythmias, compression of main abdominal vasculature (Inferior Vena Cava and abdominal aorta) and stretch of the peritoneal cavity with consequent parasympathetic irritation causing baradycardia.[8][9][10][11][12].

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
None

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: any age.
  • Sex: Male and Non pregnant female.
  • Patients with cardiopulmonary diseases.
  • Patients who diagnose acute cholecystitis not improving on medical treatment for 48 hours.
  • Patients with biliary colic, mucocele of gall bladder and pyocele of gall bladder.
  • American Society of Anesthesiologist's (ASA) score: grade I, II, III.

排除标准

  • ASA grade IV
  • Patients refuse surgery.
  • Documented Liver disease.
  • Previous percutaneous cholecystostomy
  • Cases not tolerated CO2 insufflation from the start.

结局指标

主要结局

duration of operation in minutes

时间窗: 2 hours

time taken to complete the surgery in minutes

次要结局

  • stricture of the biliary tract(2 years)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Tamer Alsaied Alnaimy

assistant professour

Zagazig University

研究点 (3)

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