跳至主要内容
临床试验/NCT02688244
NCT02688244Unknown不适用

Randomized Trial Comparing Irrigation Versus Suction in Laparoscopic Appendectomy for Complicated Acute Appendicitis in Adults

Hospital Universitario Virgen de la Arrixaca2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
210
试验地点
2
主要终点
Incidence of post-operative abscess

研究概览

简要总结

This study evaluates the intraabdominal abscess rate after laparoscopic appendectomy in complicated acute appendicitis performing irrigation of the abdominal cavity or only suction without lavage.

详细描述

Despite the available literature for and against the irrigation of the abdominal cavity in complicated acute appendicitis, in the current practice of this and other centres, the irrigation and no irrigation is made equally depending on the surgeon who performs the intervention.

Those who systematically irrigate the abdominal cavity in laparoscopic appendectomies do it as an inherited act from open surgery and those who systematically do not irrigate the abdominal cavity base their choice in theories such as abscess migration due to the irrigation and difficulty of the suction of all the irrigated fluid, spreading, therefore, the infection.

The intention of the investigators is to provide evidence about this technique in order to either systematize peritoneal irrigation in laparoscopic appendectomy for complicated appendicitis or avoid an unnecessary gesture, if it were established so.

This will be a prospective, randomized clinical trial involving patients who present to the hospital with complicated acute appendicitis. Power calculation was based on abscess rate in the investigators' hospital calculated retrospectively (15%) Subjects will be those patients above 18 y.o. who are found to have complicated acute appendicitis (defined as perforated appendicitis before or during surgery, gangrenous appendicitis and/or purulent peritonitis).

The final decision to include a patient in the study will made after complication has been visually confirmed during surgery. The randomization assignment will be made known at the initiation of the operation, and confirmation of complication will confirm the patient will utilize the next randomization slot.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with complicated acute appendiccitis
  • Laparoscopic approach

排除标准

  • Open approach
  • Medical or psychiatric condition of the patient that compromises the informed consent authorisation
  • Non complicated acute appendicitis
  • Underage patients (<18)
  • Refusal to participate in the study.

结局指标

主要结局

Incidence of post-operative abscess

时间窗: 1 month

Number of post-operative abscesses in each arm

Location of post-operative abscess

时间窗: One month

Number of abscesses in every quadrant of the abdomen

Treatment of post-operative abscess

时间窗: One month

Number of post-operative abscesses treated with a radiological drain

次要结局

  • Hospital stay (Time until discharge)(2 weeks)
  • Operating time(1 day)
  • Postoperatory fever(6 days)
  • Postoperative pain (Visual analogic scale)(6 days)

研究者

发起方
Hospital Universitario Virgen de la Arrixaca
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jesus Abrisqueta Carrion

PhD

Hospital Universitario Virgen de la Arrixaca

研究点 (2)

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