Intra-Abdominal Instillation Of Fresh Frozen Plasma Versus Corticosteroids In Prevention Of Recurrent Attacks Of Adhesive Intestinal Obstruction: A 2 Years' Experience Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- intestinal obstruction
研究概览
简要总结
Adhesive Intestinal obstruction is an inevitable complication of abdominal surgery with significant morbidity associated with poor quality of life and predispose to repeated hospitalization. Most of them (73% - 90%) can be managed conservatively.Despite advances in surgery, 15to 30% require surgical intervention primarily or due to failure of conservative management. Because of the nature of the disease recurrence has been estimated to be 30%.Many attempts to prevent formation of postoperative adhesions have been tried. In this trial, we will study the effect of corticosteroids and FFP in prevention of adhesive small bowel obstruction recurrence for follow up of 2 years duration.
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
- Double (Participant, Care Provider)
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
- •Patients with attacks of adhesive intestinal obstruction
排除标准
- •Associated abdominal malignancy, patients with adhesive IO who respond to conservative treatment.
研究组 & 干预措施
group I: adhesive intestinal obstruction
干预措施: intra-abdominal instillation of corticosteroids (Procedure)
group II: adhesive intestinal obstruction
干预措施: intra-abdominal instillation of fresh frozen plasma (Procedure)
结局指标
主要结局
intestinal obstruction
时间窗: from 1 day to 2 years post operative
intestinal obstruction is detected if the patient had constipation and vomiting with ultrasound showing dilated bowel and to and fro movement and the plain erect shows multiple air fluid levels
bowel injury
时间窗: from 1 day to 2 years post operative
bowel injury will be detected if intestinal contents present in the drain or wound
wound infection
时间窗: from 1 day to 2 weeks post-operative
wound infection is detected if there is pus in the drain or wound
次要结局
- age(from 2 to 3 days before surgery)
- sex(from 2 to 3 days before surgery)
研究者
Reham Zakaria Mohamed Ahmed
lecturer of general surgery
Zagazig University
