Laparoscopic Surgery of Rectal Cancer and Ileostomy. Technological Progress in Relation to New Minimally Invasive Treatment Methods and the Incidence of Complications.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- Number of participants with anastomotic leakage
研究概览
简要总结
Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of anastomotic leakage and the complications related to its presence and take down were analyzed.
详细描述
From a prospective collected database, data regarding patients who underwent to laparoscopic TME, with (Group 1) or without (Group 2) elective diverting ileostomy for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma, have been retrospectively analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 67 Years 至 86 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients (aged 18 years and over)
- •patients submitted to elective Anterior Rectal Resection
排除标准
- •chronic use of immunosuppressant agents
- •urgent surgery
结局指标
主要结局
Number of participants with anastomotic leakage
时间窗: 90 days
Leakage was defined on the basis of perianastomotic drain appearance and/or of radiological findings during postoperative X-Ray or abdominal CT scan enema
次要结局
- Number of participants with perforation(90 days)
- Number of participants with anastomotic stenosis(90 days)
- Number of participants with fever Surgical site infection Abdominal collections Anastomotic leakage Anastomotic bleeding Perforation Anastomotic stenosis Number of participants with fever(90 days)
- Number of participants with post-operative complications(90 days)
- Number of participants with surgical site infection(90 days)
- Number of participants with abdominal collections(90 days)
- Number of participants with anastomotic bleeding(90 days)
研究者
Vincenzo La Vaccara
Principal Investigator
Campus Bio-Medico University