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临床试验/NCT00529412
NCT00529412已完成3 期

Bioresorbable Membrane to Reduce Postoperative Small Bowel Obstruction in Patients With Gastric Cancer. A Randomized Clinical Trial

Nihon University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2003年8月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
150
试验地点
2
主要终点
incidence of small bowel obstruction

研究概览

简要总结

To assess whether the use of Seprafilm reduces the rate of small bowel obstruction in patients who underwent surgery for gastric cancer.

详细描述

Patients with gastric cancer who were scheduled to undergo gastrectomy were randomly assigned to a sodium hyaluronate-based bioresorbable membrane (Seprafilm) group or to a control group. Before closing the abdominal incision, two sheets of Seprafilm membrane were applied to the surface of the small intestine under the middle abdominal wound in the Seprafilm group. The primary end point was the incidence of bowel obstruction. Secondary end points were intraoperative and postoperative morbidity and mortality.

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, Investigator)

入排标准

年龄范围
— 至 79 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of gastric cancer

排除标准

  • Withdrew consent
  • Distant metastasis
  • Liver dysfunction (serum total bilirubin >2.0 mg/dL)
  • Renal failure (serum creatinine >1.5 mg/dL)
  • A past history of small bowel obstruction.

结局指标

主要结局

incidence of small bowel obstruction

时间窗: 3 years, more than 6 months after gastrectomy

次要结局

  • intraoperative and postoperative morbidity and mortality.(3 years)

研究者

申办方类型
Other

研究点 (2)

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