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临床试验/NCT06084741
NCT06084741已完成不适用

Omitting of Usage of Intraabdominal Drains After Repair of Peptic Ulcer Perforations Compared to Traditional Use of Drains; Comparative Study

Cairo University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年3月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia

研究概览

简要总结

. This study aimed to evaluate ERAS application outcomes via omitting the intraabdominal drains compared to regular using of the drains in patients undergoing perforated duodenal ulcer repairs in emergency abdominal surgeries.

详细描述

Patients will be randomly assigned into two groups. In Group A : the investigators will put intraabdominal drains, and in Group ,thd investigators will not put any intraabdominal drains. Our primary outcomes will be hospital stayl engthand pain score;Data analysis packages will be SPSS version 21 Qualitative data will be presented by number and percentage, quantitative data by mean, standard deviation, median and interquartile range.

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

入选标准

  • - Patients older than 18 years with perforated peptic ulcer who underwent exploratory laparotomy or laparoscopy and repair with omental pedicle techniques will included in the study.

排除标准

  • preoperative shock on admission.
  • Delayed presentation more than 24 hours.
  • known malignant gastric ulcers confirmed by histopathology.
  • the presence of neuropsychiatric disease, pregnant and lactating women.
  • predisposing factors for impaired wound healing (e.g., currently using immunosuppressive agents, or chronic use of steroids), the presence of HIV/AIDS.
  • Intraoperative findings consistent with malignant ulcers. • American Society of Anesthesiologists grade III/IV, or had an alternative perioperative diagnosis. • Ulcer size more than 2 cm in diameter.

结局指标

主要结局

number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia

时间窗: 30 days

number of patients with infection-related postoperative complications such as superficial, deep or organ space SSI, hospital acquired pneumonia

incidence of Post operative repair leak

时间窗: 30 days

incidence of Post operative repair leak

number of days of hospital stay

时间窗: Up to 30 days

hospital stay length

次要结局

  • number of days before frist bowel motion(7 days)
  • severity of operative pain measured by Visual Analogue Scale (VAS(7 days)
  • INCIDENCE OF postoperative nausea and vomiting (PONAV(7 days)

研究者

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

Mohammed Elshwadfy Nageeb

Lecturer of general surgery

Cairo University

研究点 (2)

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