DRKS00029682招募中不适用
Impact of a Digital Surgical Workflow and Digital Device Briefing Tool on Morbidity and Mortality in a Patient Population undergoing Primary Stapled Colorectal Anastomosis for Benign or Malignant Colorectal Disease: A Non-Interventional, Prospective Cohort Study - DDBT
Johnson & Johnson Medical GmbH0 个研究点目标入组 528 人开始时间: 2022年9月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 528
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patients satisfying the following criteria will be considered eligible for enrollment in this study:
- •- Undergoing left hemi-colectomy, sigmoidectomy, anterior rectal resection or Hartman Reversal operation for benign or malignant pathology in which the Ethicon circular stapler (CDH/B) is planned to be used for stapled colorectal anastomosis.
- •- All standard surgical techniques of the clinical sites (open, laparoscopic, robotic) can be used during the study execution.
- •- Willingness to give consent and comply with all study-related evaluations and visit schedule.
- •- At least 18 years of age.
排除标准
- •Patients meeting any of the following criteria will be considered ineligible for enrollment or analysis in this study:
- •a)Preoperative
- •- Physical or psychological condition which would impair study participation.
- •- The procedure is a revision/reoperation for the same indication or same anatomical location.
- •- The procedure is an urgent or emergency colorectal surgery.
- •b)Intraoperative
- •- Nonrestorative surgery (anastomosis not made)
- •- Study device (Ethicon circular stapler CDH/B) not attempted.
研究者
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