跳至主要内容
临床试验/CTRI/2023/11/059957
CTRI/2023/11/059957尚未招募3 期

EARLY VERSUS DELAYED LAPAROSCOPIC CHOLECYSTECTOMY IN ACUTE CHOLECYSTITIS

NITU SINGH1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
EARLY LAPAROSCOPIC CHOLECYSTECTOMY HAS SHORTER DURATION OF SURGERY AND THE HOSPITAL STAY

研究概览

简要总结

Acute cholecystitis isthe most common acute disease in hepatobiliary surgery and one of the mostcommon diseases in digestive tract surgery in general (1). With aging, theincidence increases from 4% in the third decade to 27% in the seventh decade oflife (2). Biliary calculosis is undoubtedly a disease of modern man. At least20% of the human population is thought to have cholelithiasis but inthe most developed countries of the world this percentage is higher. The factis that this disease is much more common in areas where the diet is irrational(fat-rich and high- calorie diet).

The incidence of thedisease increases with age.

Women of childbearing age are more likely to suffer than men(1.5-3.0:1). There is a 4F formula that is attractive but does not explain themechanism and occurrence of biliary calculosis (female, forty, fat andfertile). It should also be known that almost 50% of biliary lithiasis isasymptomatic and is detected accidentally during some clinical trials. Cholecystectomy is method of choicefor treatment of gallbladder calculosis.Open cholecystectomy has been the “gold standard†for symptomatic cholelithiasisfor a century. However, in the last two decades the introduction oflaparoscopic cholecystectomy has revolutionized the treatment of gallbladdercalculosis (4).

Laparoscopic cholecystectomy is nowconsidered to be the procedure of choice that achieves a shorter recoveryperiod and reduced treatment costs. In earlier years acute cholecystitis wasregarded as a relative contraindication for laparoscopic cholecystectomybecause of inflammatory changes that impair tissue quality and make it difï¬cultto accurately visualize anatomical structures.

As technological advances have beenaccompanied by improvements in surgical performance laparoscopy has become the“gold standard†in the treatment of chronic cholecystitis with cholelithiasis,and over time the indications widen and acute gallbladder inflammation is alsoresolved by laparoscopy.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
16.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • •Patients who have been clinically and radiologically diagnosed as acute cholecystitis along with patients who have been previously diagnosed as a case of cholecystitis brought to the hospital with acute attack and planned for laparoscopic cholecystectomy.

排除标准

  • •All patients who are medically unfit for laparoscopic cholecystectomy 2)Persisting symptoms or failure of medication 3)Acute Calculus Cholecystitis with CBD stones 4)Perforation/peritonitis 5)Chronic Cholecystitis 6)Common bile duct stones 7)Carcinoma of Gall Bladder 8)Empyema Gall Bladder 9)Emphysematous Cholecystitis.

结局指标

主要结局

EARLY LAPAROSCOPIC CHOLECYSTECTOMY HAS SHORTER DURATION OF SURGERY AND THE HOSPITAL STAY

时间窗: 3 DAYS

次要结局

  • Early laparoscopic cholecystectomy morbidity & mortality are similar to those of elective delayed cholecystectomy(12 months)
  • EARLY LAPAROSCOPIC CHOLECYSTECTOMY HAS SHORTER DURATION OF SURGERY AND THE HOSPITAL STAY(6 WEEKS)

研究者

发起方
NITU SINGH
申办方类型
Other [self]

研究点 (1)

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