跳至主要内容
临床试验/NCT04373447
NCT04373447已完成不适用

Laparoscopic Cholecystectomy is no More Risky in Emergent Cases With in Cardiopulmonary Risk: Fundus-Callot Cholecystectomy With Low Pressure Pneumo-peritoneum VS Open 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1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

研究概览

简要总结

Introduction:

In the last decades and due to improvement of medical heath care, large number of elderly persons were prevalence. Old age usually had cardiopulmonary different diseases. Biliary problems are high in old age. advancement of laparoscopic that occurred in the last years made the use of laparoscopy is available in these cardiopulmonary risk patients. many studies faced the role of laparoscopy in acute cholecystitis in elderly but no studies stated a new and a safe laparoscopic approach to the patients.

Aim: compare between Fundus-Calot cholecystectomy with low pressure pneumo-peritoneum VS open cholecystectomy in Emergency cases with cardiopulmonary risk patients as regard intraoperative data and postoperative complications.

Patients and methods:

This study prospective randomized controlled study was conducted on 374 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-Calot approach (235cases) and Group B (235cases): classical open approach

详细描述

  1. INTRODUCTION Evolving the role of laparoscopy in the last decades in managing of different surgical diseases especially biliary diseases had made laparoscopic cholecystectomy of special interest in the field of surgery. The wide spread of use of laparoscopic cholecystectomy put this surgery in the front line of the commonest operation performed in digestive system surgery and really put open cholecystectomy a side.[ Gouma DJ, Rauws EA, Lameris JS. Bile duct injury after cholecystectomy: risk of mortality substantially higher. NedTijdscr Genseeskd 2004; 148: 1020-24.]

Laparoscopic cholecystectomy advantages are numerous to both the doctors and the patients. Advantages to the surgeons are safety and rapidity of the operation with experienced surgeons. To the patients as regard small sized operative wounds, less pain postoperative, less wound infection and hence rapid discharge from hospital and regain its usual daily activities . [Stanisic V, Bakic M, Maqgelinic M, Kolasinac H. Babic I. [Laparoscopic cholecystectomy of acute cholecystitis]. Med Preql 2010; 63: 404-8.]

Despite the fact that laparoscopic approach had many benefits over open approach, yet many hazards may occur from laparoscopic cholecystectomy starting with viscous injury during induction of pneumoperitoneum and conversion till fatal biliary and vascular injuries during blind and insisted dissection of disturbed anatomy and frozen Calot triangle. these complications may occur with best surgical hands and decreased with increasing learning curve.[ Russel JC, WalshSJ, Mattie AS, Lynch JT. Bile duct injuries.1989- 1993: A state wide experience: Connecticut laparoscopic cholecystectomy registry. Arch Surg 1996; 131:382-8.][ Atmaram DC, Lakshman K. Predictive factors for conversion of laparoscopic cholecystectomy. Indian J Surg 2011; 73: 42-3] a study put us on the way to avoid bile duct injuries [5].

The incidence of gall bladder disease increase with advancement of age so that 20-30% of patients undergo laparoscopic cholecystectomy is elderly patients > 60 years with cardiopulmonary risks. and increase to 80 % after 90 years .Elderly patients had cardiopulmonary risks and reduced physiological reserve [Festi D, Dormi A, Capodicasa S, Staniscia T, Attili AF, Loria P, et al: Incidence of gallstone disease in Italy: results from a multicenter, population-based Italian study (the MICOL project). World J Gastroenterol 2008; 14:5282-5289.] [Ratner J, Lisbona A, Rosenbloom M, Palayew M, Szabolcsi S, Tupaz T: The prevalence of gallstone disease in very old institutionalized persons. JAMA 1991; 265: 902-903.]. Other study stated lower incidence of acute cholecystitis in the elderly group of only 6%[ S. W. Lee, S. S. Yang, C. S. Chang, and H. J. Yeh, "Impact of the Tokyo guidelines on the management of patients with acute calculous cholecystitis," Journal of Gastroenterology and Hepatology, vol. 24, no. 12, pp. 1857-1861, 2009.]

Insufflation of CO2 induces both hemodynamic and mechanical effects. Compression of the vascular system decrease cardiac output due to increase peripheral resistance. Abdominal distension hinder movement of diaphragm. [ Enciso NJ (2013) Anestesia en la cirugía laparoscópica abdominal. An Fac med 74(1): 63-70.].

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 neurological, renal and Liver disease.
  • Previous percutaneous cholecystostomy
  • Cases not tolerated CO2 insufflation from the start.
  • Other associated problems as acute cholangitis, pancreatitis, gastro-intestinal cancer or bile duct diseases

结局指标

主要结局

duration of operation

时间窗: 2 hours

in minutes

次要结局

未报告次要终点

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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