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临床试验/NCT01458353
NCT01458353Unknown3 期

Microbiological Spectrum of the Intraperitoneal Surface After Elective Right-sided Colon Cancer: Are There Differences in the Peritoneal Contamination After Performing a Stapled or a Handsewn Anastomosis?

Hospital General Universitario Elche2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
80
试验地点
2
主要终点
Peritoneal contamination after finishing the ileocolonic anastomosis

研究概览

简要总结

Despite performing colonic surgery with strict asepsia measures, minimizing the contact of the colon lumen with the peritoneum, some contamination is nearly impossible to avoid. In stapled anastomosis, the hole opened in the colon is minimum, just the necessary for introducing the parts of the mechanical devices. In handsewn anastomosis, the colonic lumen is more exposed to the peritoneum, despite the colonic occlusion with clamps meanwhile the suture is performed.

Hypothesis: After stapled anastomoses, the peritoneal contamination should be lower than after handsewn ones.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • diagnosis of right-sided colon cancer and plans to undergo an elective surgery with curative aims.

排除标准

  • 未提供

结局指标

主要结局

Peritoneal contamination after finishing the ileocolonic anastomosis

时间窗: 1 year

Swabs will be obtained from the peritoneal surface for microbiological culture

次要结局

未报告次要终点

研究者

发起方
Hospital General Universitario Elche
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jaime Ruiz-Tovar, MD, PhD

Doctor in Surgery by Universidad Autonoma de Madrid (Spain)

Hospital General Universitario Elche

研究点 (2)

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