Prospective Evaluation of NOTES (Natural Orifice Translumenal Endoscopic Surgery) PEG "Rescue" (PEGRescue)
2014年12月12日 更新者：Jeffrey Marks, MD、University Hospitals Cleveland Medical Center
Prospective Evaluation of NOTES PEG "Rescue"
The purpose of this study is to determine:
- Utility of urgent upper endoscopy in setting of dislodges (percutaneous endoscopic gastrostomy) PEG tube.
- Feasibility of replacing naive PEG tubes with Natural Orifice Translumenal Endoscopic Surgery (NOTES) in lieu of traditional surgical methods.
- Efficacy of replacing naive PEG tubes with NOTES in lieu of traditional surgical methods.
研究概览
详细说明
Utility of Urgent Upper Endoscopy in Setting of Naïve Dislodged PEG Tubes as defined by:
- Percentage of Open vs. Closed Gastrotomy upon urgent endoscopy
- Presence of Incidental Pathology noted on Endoscopy
- Complications of Urgent Endoscopy
- Time of Procedure
Technical Feasibility of the NOTES procedure determined by:
- Number of Successful/Failed PEG Placements
- Number of Patients Requiring intra-operative conversion to laparotomy or laparoscopic procedure
- Time to Complete Procedure
- Presence or absence of post-procedural contrast extravasation on completion contrast radiographic study
Efficacy of NOTES PEG Rescue compared to historical controls as characterized by the following post-operative criteria:
- Number of Patients Requiring Subsequent Medical or Surgical Treatment for Intra-Abdominal Abscess
- Number of Patients Requiring Subsequent Medical or Surgical Wound Infection within 30 post-op days
- Post-Operative CT or Operative Findings consistent with abscess confirmed by culture positive drainage, aspiration
- Intra-Operative or Post-Operative Red Blood Cell Transfusion
- Length of Stay
- Antibiotics > 24h Post-Op
- 30 day Re-Admission
- Mortality
研究类型
介入性
注册 (实际的)
1
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
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Ohio
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Cleveland、Ohio、美国、44106
- University Hospitals Case Medical Center
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 85年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria: Patients must meet ALL of the following criteria
- For prospective candidates, an initial attempt to pass a balloon tipped foley catheter through the external cutaneous tract into the stomach will be performed. It will then be followed by radiographic contrast study to evaluate for extravasation of contrast into the peritoneal cavity. If contrast is extravasated, this will be potential candidate for inclusion. If the foley catheter is unable to be passed through the cutaneous tract, that will also be considered someone for inclusion as this patient will still require an operative confirmation of the patency of the gastrotomy.
- For retrospective candidates, intra-operative confirmation of dislodged tube as reported in the medical record.
- The patient must demonstrate pre-operative hemodynamic and respiratory stability
- No overwhelming medical co-morbidities prohibitive of surgery
- Subject is 18 years of age or older
- Subject or subject's legal decision-making proxy agrees to participate, fully understands and signs the informed consent form
Exclusion Criteria: Patients must not meet ANY of the following criteria:
- Esophageal stricture prohibiting passage of an endoscope
- Any contraindication to surgery
- Pregnancy or actively breastfeeding women
- Evidence of active bowel obstruction
- Synchronous acute abdominal pathology warranting incision-based surgery
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：NOTES PEG Rescue
A new way of performing surgery is called Natural Orifice Translumenal Endoscopic Surgery, or NOTES, for short.
NOTES may allow surgeons to perform abdominal surgery without any skin incisions.
By using natural openings in the body, like the mouth, surgeons can enter the stomach with a tube instead of the traditional method of making an incision in the skin of the abdomen.
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Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions.
No clear indication due to a number of physiologic, microbiologic, immunologic, and technical limitations.
The concept of NOTES PEG "Rescue" in the setting of a dislodged naïve PEG tube may spare individual patients the physiologic stress of traditional surgery while concomitantly providing a natural segue to further study the NOTES platform in the human setting.
PEG "Rescue" may represent a unique, practical, and empowering application of the burgeoning experience of natural orifice translumenal endoscopic surgery.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.
大体时间：30 day follow-up
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Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.
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30 day follow-up
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jeffrey Marks, MD、University Hospitals Cleveland Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2007年11月1日
初级完成 (实际的)
2010年7月1日
研究完成 (实际的)
2010年7月1日
研究注册日期
首次提交
2010年5月6日
首先提交符合 QC 标准的
2010年5月6日
首次发布 (估计)
2010年5月7日
研究记录更新
最后更新发布 (估计)
2015年1月5日
上次提交的符合 QC 标准的更新
2014年12月12日
最后验证
2014年12月1日
更多信息
与本研究相关的术语
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