Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma - A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- intraoperative blood loss in ml, quantitative
研究概览
简要总结
the study is designed to compare the blood loss between laparoscopic vs open pancreaticoduodenectomy in a randomized clinical trial
详细描述
the study will assess the difference in the amount of blood loss in Lap vs Open WPD. the amount of blood loss will be calculated on the basis of a formula which takes pre operative and post operative hematocrit, PCV and blood volume into consideration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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 of both the sex aged between >18 years.
- •Patients with a diagnosis of resectable periampullary carcinoma on imaging.
- •Patients with ASA grade 1 or 2
排除标准
- •Patients found to have unresectable disease on radiological investigation. 2) Patients with ASA grade 3 or above
研究组 & 干预措施
Open pancreaticoduedenectomy
will include all the patients who will undergo open pancreaticoduodenectomy
干预措施: pancreaticoduodenectomy (Procedure)
Laparoscopic pancreaticoduodenectomy
will include all the patients undergoing laparoscopic pancreaticoduodenectomy
干预措施: pancreaticoduodenectomy (Procedure)
结局指标
主要结局
intraoperative blood loss in ml, quantitative
时间窗: 24 hours
blood loss will be assessed with the help of a formula which uses preoperative and post operative hematocrit, blood volume and PCV
次要结局
未报告次要终点
研究者
Hirdaya H Nag, MS
Professor
Govind Ballabh Pant Hospital