Perioperative Outcomes in Total infragastric Omentectomy with or without Perigastric Arcade Resection in advanced epithelial OVarian cancer: A non-inferiority randomized-controlled-trial(POTOPAR-OV)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- To compare perioperative complication rates between total infragastric
研究概览
简要总结
Despite the omentum being an established site for epithelial ovarian cancer metastases, the extent of its removal has not yet been adequately addressed. Removal of the perigastric arcade (PGA) of the omentum is one of the controversial aspects of omentectomy given its proximity to the stomach and thus the fear of injury, vascular compromise, and gastroparesis. There are no specific guidelines regarding the level of omentectomy, and therefore, in an attempt to fill the existing gaps in recent evidence, we are conducting the current study to assess the distribution of microscopic disease in the PGA (including the left and right gastro-epiploic vessels) in patients with epithelial ovarian cancer without macroscopic involvement of PGA and to compare intraoperative and immediate postoperative complications and the course of recovery in patients in whom the PGA was resected and those in whom the arcade was preserved during omentectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- Female
入选标准
- •Stage III or IV epithelial ovarian cancer patients undergoing primary cytoreductive or interval cytoreductive surgery.
排除标准
- •Gross disease present in perigastric arcade part of omentum during intraoperative assessment.
- •Previous gastric surgery Recurrent ovarian cancer.
结局指标
主要结局
To compare perioperative complication rates between total infragastric
时间窗: one week post surgery
omentectomy with or without perigastric arcade resection during cytoreductive
时间窗: one week post surgery
surgery in advanced epithelial ovarian cancer
时间窗: one week post surgery
次要结局
- To assess the rate of microscopic involvement of the perigastric arcade of the omentum in patients undergoing total infragastric omentectomy with perigastric arcade resection & their predictive factors.(Two weeks post surgery)
- To compare other perioperative outcomes between two arms including intraoperative blood loss, operative time, intensive care unit (ICU) admission rates & length of hospital stay (days).(one week post surgery)
- To compare patients quality of life after 30 days of surgery among the perigastric arcade removal and perigastric arcade preserving groups based on EORTC QLQ-OV28 questionnaire.(1 month post surgery)
- To compare the disease-free survival in both perigastric arcade removal and perigastric arcade preserving groups after 6 months of surgery.(six months post surgery)
研究者
Manjunath Shantaram Nayak
All India Institute Of Medical Sciences Jodhpur