Prospective Evaluation of the Intraoperative Use of Translumenal Flexible Endoscopes During Combined Flexible and Laparoscopic Foregut and Urologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- 30 day Post-op NOTES feasibility outcomes:
研究概览
简要总结
NOTES access is safe and feasible in the controlled human setting and comparable to standard-of-care surgical techniques. NOTES exploration of the abdomen provides adequate visualization comparable to laparoscopy.
详细描述
This is a prospective clinical trial to evaluate the feasibility of obtaining peritoneal cavity access from natural orifice translumenal endoscopic surgery (NOTES) during combined laparoscopic-endoscopic foregut surgery. Post-operative course will be compared with a historical chart-review control group of patients undergoing standard laparoscopic foregut and urologic surgery.
The study group will be compiled by open enrollment for male and female adult subjects scheduled for combined laparoscopic-endoscopic surgery of the stomach, abdominal esophagus, prostate, bladder, proximal small intestine or who meet inclusion and exclusion criteria. The historical chart-review control group will be randomly chosen from patients from 2003-2006 having undergone combined laparoscopic-endoscopic surgery of the foregut, prostate, or bladder and as determined by CPT coding.
The purpose of the study is to determine if NOTES access and abdominal exploration is feasible, safe, offers comparable visualization to laparoscopy in a controlled human setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing an already combined laparoscopic and endoscopic foregut procedure with general anesthesia
- •Patients undergoing a prostatectomy or cystectomy with general anesthesia
- •All patients will have a planned gastrotomy for exploration, foreign body removal, or removal of tissue, making it a contaminated case or a planned cystotomy or urethrotomy for exploration, foreign body removal or removal of tissue such as prostatectomy or bladder resection.
- •No overwhelming medical co-morbidities
- •Subject is 18 years of age or older
- •Subject is his or her own medical decision maker
- •Subject agrees to participate, fully understands content of informed consent form, and signs the informed consent form
排除标准
- •Patients undergoing a non-palliative procedure in the face of resectable adenocarcinoma of the foregut or genitourinary tract
- •Linitis Plastica
- •Evidence of Active Bowel Obstruction
- •Patients with history of oropharyngeal, esophageal, or gastric adenocarcinoma.
- •Esophageal stricture prohibiting passage of an endoscope
- •Urethral stricture prohibiting passage of an endoscope
- •Emergent Surgery
- •At any time during pre-operative or intra-operative periods, evidence of unresectability is demonstrated
- •Any intra-operative condition prior to surgical resection that results in abortion of the surgical procedure
- •Any contraindication to surgery
- •Pregnancy or actively breastfeeding women
- •Prisoners or Wards of State
研究组 & 干预措施
Prospective
Subjects scheduled to receive procedure
干预措施: Natural Orifice Transluminal Endoscopic Surgery (NOTES) (Procedure)
Historical
Chart review control group
干预措施: Natural Orifice Translumenal Endoscopic Surgery (NOTES) (Procedure)
结局指标
主要结局
30 day Post-op NOTES feasibility outcomes:
时间窗: 30 days post-op
* Number of successful NOTES access attempts * Number of failed NOTES access attempts * Injury to collateral organs or structures * Time to gain access to peritoneal cavity * Necessary balloon dilator size required for translumenal passage of endoscope
次要结局
- 30 Day Post-OP Evaluation of Efficacy of NOTES access when compared to historical control groups undergoing laparoscopic access during foregut surgery(30 Day Post-OP)
- 30 Day NOTES Post - Op Evaluation of Adequacy of Abdominal Exploration(30 Day Post - Op)
研究者
Jeffrey Marks, MD
Prinicpal Investigator
University Hospitals Cleveland Medical Center