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临床试验/NCT05736003
NCT05736003已完成不适用

Prolonged Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis: Time to Change the Concept - A Multicenter Randomized Controlled Trial

South Valley University2 个研究点 分布在 1 个国家目标入组 437 人开始时间: 2019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
437
试验地点
2
主要终点
Overall morbidity

研究概览

简要总结

Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial.

Early laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone for the DLC.

详细描述

Gallbladder stone affects 10-15% of the adult population, and about 15-25% of these patients presented with acute cholecystitis (AC). Laparoscopic cholecystectomy (LC) is considered the treatment of choice for patients with AC, and recent studies suggest that early laparoscopic cholecystectomy (ELC) is preferable. However, the optimal time for ELC in AC is still controversial.

Early laparoscopic cholecystectomy (ELC) was advised for patients presented within 72 hours, while conservative treatment and planned delayed laparoscopic cholecystectomy (DLC) after six weeks was recommended for patients presented after 72 hours. ELC might be associated with a significant reduction in morbidity and mortality rates, comparable conversion rates, shorter hospital stays, lower costs, and higher patient satisfaction.

Surgeons almost always encounter patients with AC lasting more than 72 hours and these patients consistently refuse conservative treatment and postpone the DLC. Additionally, 15% of patients do not respond to the conservative treatment and still need an emergency cholecystectomy and another 25% of patients require re-hospitalization for recurrent attacks of AC and biliary colic, biliary pancreatitis, cholangitis, and calcular obstructive jaundice during the interval waiting for the DLC. Furthermore, DLC has a higher cost and is time-consuming.

Prolonged LC (PLC) for AC after 3 days from onset of symptoms was thought to be more technically difficult and dangerous because of altered anatomo-pathology where suppurative and subsequently necrotizing cholecystitis develops after edematous cholecystitis during the first 2 to 4 days of symptoms, and this may be associated with increased perioperative complications and conversion rate. On the contrary, others believed that hyperemia and edema may help the dissection. All the studies in the literature focus on the ELC and DLC with little data regarding the safety and feasibility of LC for acute cholecystitis beyond 72 hours of symptoms.

More clinical trials are needed for the optimal management of acute cholecystitis after 72 hours of symptoms. The aim of this study was to compare the clinical outcomes of prolonged and delayed LC in patients with acute cholecystitis more than 72 hours of symptoms.

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
Double (Participant, Investigator)

入排标准

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

入选标准

  • Patients diagnosed with acute cholecystitis beyond 72 hours of symptoms onset,
  • American Society of Anesthesiologists (ASA) scores I - III,
  • Aged 20-70 years,
  • Agreement to complete the study

排除标准

  • Gallbladder polyp,
  • common bile duct stones,
  • acute biliary pancreatitis,
  • cholangitis,
  • perforated cholecystitis,
  • biliary peritonitis,

结局指标

主要结局

Overall morbidity

时间窗: 30 days

The overall morbidity included failure of initial conservative treatment, emergency consultation, unplanned hospital readmission for recurrent attacks of AC or gallstone-related complications, subtotal cholecystectomy, and intra- and postoperative complications

次要结局

  • conversion rate(3 years)
  • Operative time(3 hours)
  • Total Cost(3 years)
  • Mortality(30 days)
  • Total antibiotic duration(3 years)
  • Morbidity(30 days)
  • Total length of hospital saty(3 years)
  • Lost days of work(3 years)

研究者

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

Mohammed Ahmed Omar, MD

Associate professor of surgery

South Valley University

研究点 (2)

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