Laparoscopic Management of Periappendicular Abscess - Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time of hospitalization within the first 60 days after randomization
研究概览
简要总结
According to retrospective studies the conservative management of periappendicular abscess is associated with decreased complication and re-operation rate compared with open appendectomy. Large abscesses require percutaneous drainage. Sometimes percutaneous drainage is not possible because of anatomical position of the abscess and surgical treatment is needed. The purpose of this study is evaluate whether laparoscopic appendectomy is suitable for the first-line treatment in patients with periappendicular abscess.
The hypothesis of the study is that laparoscopic management of periappendicular abscess is suitable for the first-line treatment and it does not increase time of hospitalization or complication rate compared with conservative management.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Periappendicular abscess at least 2 cm in size
排除标准
- •Missing written informed consent
- •Antimicrobial therapy lasted over 24 hours before randomization
- •Attempt of drainage before randomization
- •Age over 80 years or under 18 years old
- •Pregnancy
- •Allergy to either Cefuroxime or Metronidazole
- •Severe chronic disease, that substantially increases the risk for operative mortality
- •Previous major intra-abdominal surgery, that may have caused intra-abdominal adhesions
- •Carrier of a resistant bacterial strain
- •Being institutionalized or hospitalized for at least 2 weeks before randomization
结局指标
主要结局
Time of hospitalization within the first 60 days after randomization
时间窗: Day 60 after randomization
次要结局
- Need of additional interventions(Within the first 60 days after randomization)
- Residual abscess(On day 7 after randomization)
- Attempted procedure not successfully performed(During the first 24 hours after randomization)
- The number of complications(Within 60 days from randomization)
- Number recurrent abscesses(Within 60 days after randomization)
研究者
Panu Mentula
Surgeon
Helsinki University Central Hospital