Best Management of Sigmoid Volvulus: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Mortality
研究概览
简要总结
The purpose of this study is to obtain a better understanding of the best management of left-sided colonic emergencies.
详细描述
Participants: Patients 18 years or older presenting to Kamuzu Central Hospital in Lilongwe Malawi with sigmoid volvulus will be eligible for inclusion.
Procedures (methods): This is a prospective randomized trial. Subjects will be randomized during surgery to receive resection and anastomosis or mesosigmoidopexy (for non-gangrenous sigmoid volvulus), and resection and anastomosis or Hartmann's procedure (for gangrenous sigmoid volvulus).
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
- 否
入选标准
- •clinical suspicion of sigmoid volvulus as deemed by the surgeon on duty
排除标准
- •pregnancy,
- •age under 18 years,
- •prisoners
研究组 & 干预措施
NG-SV resection and anastomosis
Nongangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis
干预措施: Resection and anastomosis (Procedure)
G-SV Resection and colostomy
Gangrenous sigmoid volvulus patients randomized to undergo resection with colostomy and delayed anastomosis
干预措施: Resection and colostomy (Procedure)
G-SV Resection and anastomosis
Gangrenous sigmoid volvulus subjects randomized to undergo resection and anastomosis
干预措施: Resection and anastomosis (Procedure)
NG-SV mesosigmoidopexy
Nongangrenous sigmoid volvulus subjects randomized to undergo mesosigmoidopexy
干预措施: Mesosigmoidopexy (Procedure)
结局指标
主要结局
Mortality
时间窗: 30-Day
Mortality within 30 days of surgery, as determined by hospital inpatient records, outpatient clinical records and telephone contact (with next-of-kin)per study protocol.
次要结局
- Recurrence of Sigmoid Volvulus(3 Year)
- Surgical Site Infection(30-Day)