Peritoneal Closure Versus Non Closure During Open Appendectomy: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Visual analogue pain score
研究概览
简要总结
There has been no consensus over closure versus non closure of peritoneum during abdominal operations. The aim of this study is to compare the effect of peritoneal closure versus non closure over postoperative pain, early complications and life quality.
详细描述
There has been no consensus over closure versus non closure of peritoneum during abdominal operations. in literature, few reports suggested that peritoneal closure may prolong the operation time, may increase the costs and has a probable aggravating effect on postoperative pain. In addition, there have been some reports that suggest non closure of peritoneum may not increase the postoperative complications. The need of further studies to clarify the effect of peritoneal closure versus non closure on postoperative pain and life quality especially has been specified in some literature. The aim of this study is to compare the effect of peritoneal closure versus non closure over postoperative pain, early complications and life quality.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with acute appendicitis
- •age between 18-65 years
排除标准
- •preoperatively diagnosed intraabdominal abcess
- •intraoperatively diagnosed free purulent fluid in abdominal cavity
- •pregnancy
- •malignancy history
- •mental retardation
- •chronical renal failure
- •chronical liver disease
- •diabetes mellitus
- •patients' denial of participation to study
结局指标
主要结局
Visual analogue pain score
时间窗: postoperative day 1
visual analogue score for pain at postoperative day 1 via using 10 cm vas scale.
Surgical Site Infection
时间窗: postoperative 30 days
Postoperative Surgical Site Infection in 30 days following surgery includes incisional infections and intrabdominal abcess
Life Quality Score
时间窗: postoperative day 10
Euro-Qol 5D-5L for assesment of life quality at postoperative day 10th
次要结局
- operation time(intraoperatively)
- wound dehiscence(postoperative 30 days)
- postoperative mortality(postoperative 30 days)