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临床试验/NCT06859307
NCT06859307进行中(未招募)不适用

Intra-Abdominal Instillation Of Fresh Frozen Plasma Versus Corticosteroids In Prevention Of Recurrent Attacks Of Adhesive Intestinal Obstruction: A 2 Years' Experience Clinical Study

Zagazig University2 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

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

Active Comparator

干预措施: intra-abdominal instillation of corticosteroids (Procedure)

group II: adhesive intestinal obstruction

Active Comparator

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Reham Zakaria Mohamed Ahmed

lecturer of general surgery

Zagazig University

研究点 (2)

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