OMentum Around Neck Anastomosis (OMANA) trial- A phase II, prospective, single-arm interventional trial of omental wrapping around cervical esophagogastric anastomosis after esophagectomy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Proportion of patients with anastomotic leak, defined as full thickness gastro intestinal defect involving esophagus, anastomosis, staple line, or conduit irrespective of presentation or method of detection as set by ECCG (Esophagectomy complications consensus group), identified clinically/radiologically. This will be analysed in the intent to treat as well as per protocol populations
研究概览
简要总结
Surgery for food pipe (esophageal) cancers involves removal of the food pipe along with the tumor in the chest and re establishment of bowel continuity by joining the remanent food pipe and stomach in the neck. This new junction is at high risk of anastomotic leakage in the post operative period, which causes significant suffering to the patient and increases the risk of death. Omentum is the fat that is attached to the stomach which is shown to be rich in blood supply and has been previously used in various gastro intestinal surgeries to augment anastomosis or repair any leaks. This technique has been tried prior in smaller studies with fewer patients undergoing esophagectomy. We aim to perform a single arm prospective trial of omental wrapping around the new junction in the neck after esophagectomy and its effect on post operative anastomotic leaks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients undergoing McKeown esophagectomy with a stapled and or hybrid and or handsewn anastomosis in the neck Written informed consent form.
排除标准
- •Retrosternal route of reconstruction Conduits other than stomach Previous gastric, pancreatic, colonic or splenic surgery that would have violated the omentum.
结局指标
主要结局
Proportion of patients with anastomotic leak, defined as full thickness gastro intestinal defect involving esophagus, anastomosis, staple line, or conduit irrespective of presentation or method of detection as set by ECCG (Esophagectomy complications consensus group), identified clinically/radiologically. This will be analysed in the intent to treat as well as per protocol populations
时间窗: At the time of surgery
次要结局
- Mean Intraoperative blood loss(After surgery)
- Median Duration of surgery
- Incidence of major postoperative complication as defined by Clavien Dindo classification (CD greather than II)
- 30-day post operative mortality expressed as a percentage(After Surgery)
- 90-day post-operative mortality expressed as a percentage
- 90 day anastomotic stricture rates expressed as a percentage(patients presenting with symptom of dysphagia at follow up within 90 days will be subjected to a esophagogastroduodenoscopy to assess for anastomotic stricture)
研究者
Dr Karthik V
Tata Memorial Hospital