A Comparative Study Between Early and Conventional Intestinal Stoma Closure at SMS Hospital, Jaipur
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- post operative anastomotic leak
研究概览
简要总结
A temporary intestinal stoma usually formed to protect distal anastomosis or as a exteriorisation of intestinal perforation where primary repair can’t be done. so timing of stoma closure is always a topic of debate. Stoma closure is usually performed after 8 -12 weeks. However quality of life is affected due to stoma-related complications during this time period.Early closure of temporary stomas may lessen patient discomfort and stoma-related morbidity. In general, intestinal continuity restoration is linked to low mortality. we believe early closure of intestinal stoma is safe and improves post operative quality of life of the patient and subsequently reduces stoma related morbidity. overall, we expect early stoma closure is superior to conventional one and this may help us to decide the timing of intestinal stoma closure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with intestinal stoma following bowel surgery 2)Patient who will give informed consent to participate in the study.
排除标准
- •Patients with coexisting malignancy 2)Severe malnourished patients 3)patients with Koch’s abdomen 4)patients with end stoma 5)patients with Diabetes/HIV 6)patients being treated with steroids 7)patients with linguistic difficulties and patients with expected low compliance.
结局指标
主要结局
post operative anastomotic leak
时间窗: at post op day 4 & 7
次要结局
- Quality of life(after 6 weeks of stoma reversal)
研究者
Dr Hanuman Ram
Sawai Mansingh Medical College and Hospital