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临床试验/NCT05267860
NCT05267860已完成不适用

The Efficacy and Safety of Using Prophylactic Abdominal Drainage After Cholecystectomy: A Randomized Control Trial.

University of Aleppo2 个研究点 分布在 2 个国家目标入组 232 人开始时间: 2022年2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
232
试验地点
2
主要终点
Morbidity /Complications

研究概览

简要总结

Investigators want to assess the safety and efficacy of using abdominal drainage with not using any drainage, by estimating different outcomes after laparoscopic cholecystectomy for different reasons. Patients are seen at the Accident and Emergency Department or in the surgical wards at Aleppo University Hospital (AUH) over 12 months period.

详细描述

The routine use of prophylactic drainage has become common in many hospitals around the world after cholecystectomy for different reasons. In elective surgeries, the evidence does not support the use of drainage. But in emergency laparoscopic cholecystectomy surgeries, using drainage remains controversial. Surgeons who support the use of drainage find it useful to identify the early complications of surgery and removing intra-abdominal collections, while opponents of drainage use believe that it increases the risk of wound infection. But, a systematic review and meta-analysis discussed the ineffectiveness of the routine use of the prophylactic drainage after laparoscopic cholecystectomy for acute cholecystitis and requested more randomized clinical trial studies on the subject. However, this study and others in the medical literature contain very few high-quality randomized controlled trials, hence our randomized controlled trial compares the use and non-use of drainage in patients undergoing laparoscopic cholecystectomy for different reasons.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
16 Years 至 90 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are seen at the Accident and Emergency Department or in the surgical wards at Aleppo University Hospital (AUH) over 12 months period.
  • Patients who undergo cholecystectomy for any reason.

排除标准

  • Non-cooperative patients for regular follow up.
  • Draining for therapeutic indications.

结局指标

主要结局

Morbidity /Complications

时间窗: 30 days after the operation

overall complication rate; graded by the Clavien- Dindo complications classification system.

次要结局

  • Intraperitoneal abscess(up to 30 days)
  • Wound infection/ Surgical site infection(up to 30 days)

研究者

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

Ahmad Yamen Arnaout

Principal Investigator

University of Aleppo

研究点 (2)

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