NCT01119040终止不适用
Prospective Evaluation of NOTES PEG "Rescue"
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.
研究概览
简要总结
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.
详细描述
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
NOTES PEG Rescue
Experimental
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.
干预措施: Natural Orifice Translumenal Endoscopic Surgery (Procedure)
结局指标
主要结局
Number of Participants With Successful Replacements of Dislodged PEG Tubes With NOTES Procedures in Lieu of Traditional Surgical Methods.
时间窗: 30 day follow-up
Successful replacement will be determined via the number of patients requiring conversion from NOTES PEG rescue to conventional incision-based surgery.
次要结局
未报告次要终点
研究者
Jeffrey Marks, MD
Principal Investigator
University Hospitals Cleveland Medical Center
研究点 (1)
Loading locations...
相似试验
撤回
不适用
EUS vs EGD in Emergency Room Patients Referred for EGDAbdominal PainNCT04408872Centre hospitalier de l'Université de Montréal (CHUM)
终止
不适用
A Pilot Study to Assess the Value of EUS vs EGD in Emergency Room Patients Referred for EGDAbdominal PainNCT03432208Centre hospitalier de l'Université de Montréal (CHUM)2
招募中
不适用
Endoscopic Submucosal Dissection (ESD)Esophageal LesionBarrett EsophagusGastrointestinal LesionsNCT05468008AdventHealth1,000
招募中
不适用
Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant CandidatesEnd Stage Renal DiseaseKidney TransplantationEndoscopic Sleeve GastroplastyObesity, MorbidNCT05917795Fondazione Policlinico Universitario Agostino Gemelli IRCCS24
Unknown
不适用
Diagnostic Laparoscopy in the Preoperative Staging of Pancreatobiliary CancerPancreatic CancerNCT02479984National Cancer Center, Korea193