Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair
研究概览
简要总结
This study is being done to see if a new approach to repair perforated ulcers in the stomach (holes in the stomach) or the first part of the intestine is possible. Traditionally, either open operations (large single incision) or laparoscopic operations (multiple small camera-guided incisions) have been used to repair perforated ulcers. Over the last ten years, some surgeons have used endoscopic equipment to assist them with performing the procedure. It is unknown if perforated ulcer repair can be done using an endoscope as the main instrument (a flexible tube with a video camera inserted into the stomach through your esophagus) to "patch" or plug the perforation. We will patch the perforation using a standard method which uses tissue from outside the stomach. A laparoscopic camera will also be used to assist our view. This study is intended to be a feasibility study to demonstrate the endoscopic technique can be safely performed
Hypothesis: The primary outcome is successful completion of the procedure.
详细描述
Perforation is the most dangerous complication of gastroduodenal ulcer disease. It accounts for more than 70% of deaths associated with peptic ulcer disease. In addition to age and concomitant disease, intervention related complications are statistically significant predictors of death after hospital stay. Age, time to presentation and comorbidities are not factors that can be influenced. If it would be possible to reduce the impact of procedure related complications or the "second hit", that may lead to decreased morbidity and mortality.
This will be a pilot clinical study to evaluate the safety and feasibility of endoscopic translumenal omental patch closure. Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. Endoscopic translumenal omental patch will be attempted first if the patient has no contraindication. Should this prove unsuccessful, the surgical team will proceed with conversion to laparoscopic or open standard surgical therapy as indicated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients presenting with clinical diagnosis of a perforated viscus who are scheduled to undergo surgical intervention
- •Surgical candidate for endoscopic, laparoscopic, or open procedure
- •Age > 21
- •Informed written consent
排除标准
- •Prior gastric or duodenal surgery
- •Prior total abdominal colectomy or transverse colectomy
- •Prior omentectomy or omental flaps
- •Known perforation site other than stomach or duodenum
- •Patients with contra-indications for laparoscopy
- •Patients with contraindications for endoscopy
- •Upper gastrointestinal anatomy that would preclude endoscopic therapy
- •Coagulopathy or thrombocytopenia
- •Pregnant patients
- •Patients <21 years of age
- •Prisoners
- •Patients found at surgery to have disease processes other than perforated peptic ulcer disease will be asked for permission to record their data for comparison
结局指标
主要结局
Number of Participants Completing Natural Orifice Translumenal Endoscopic Surgical (NOTES) Repair
时间窗: 2 days post-operation
At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage. Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated.
次要结局
未报告次要终点