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临床试验/NCT05463328
NCT05463328Unknown不适用

Open Versus Laparoscopic Assisted Pancreaticoduodenectomy: Randomized Control Comparative Prospective Study

Assiut University0 个研究点目标入组 40 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal).

研究概览

简要总结

Compare open and laparoscopic assisted pancreaticoduodenectomy regarding intraoprative blood loss, organ injury, completion of planned laparoscopic steps, duration and early post operative course of pain, hem stability, oral feeding, leakage(pancreatic, billary and intestinal). ,bleeding, mortality, lymph nodes and safety margins .

详细描述

Pancreaticoduodenectomy is the only option curative intended in the treatment of resectable pancreatic ductal adenocarcinomas, duodenal carcinoma, ampullary carcinoma, lower common bile duct cholangiocarcinoma,. It is still associated with very high morbidity and mortality. [1]. Pancreatic cancer ranks as the seventh leading cause of cancer-related death worldwide, and the fourth among other cancers[2,3]. In recent years, the minimally invasive techniques has considered revolution in surgeries of pancreatic cancers [4,5]. Laparoscopic assisted pancreaticoduodenectomy is a hybrid procedure combining laparoscopic resection and reconstruction through a small incision.it companies laparoscopic mobilization and dissection due to magnification compared with open pancreaticoduodenectomy[6]. Several studies have shown that laparoscopic assisted pancreaticoduodenectomy could result in less blood loss less, pain ,less wound infection and shorter hospital stay compared to open pancreaticoduodenectomy[7,8]. Limited literature described the safety and efficacy of laparoscopic assisted pancraticododenostomy .Also such comparative studies deficient in evaluation of outcomes of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.So the interest of our study is to compare between the feasibility and safety of laparoscopic assisted pancraticododenostomy and open pancraticoduodenoctomy.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age less than 70 years.
  • resectable tumour,
  • fit for surgery

排除标准

  • patients with jaundice with serum bilirubin above 200mml/dl.
  • patients with bleeding tendency until corrected.
  • patients with advanced and metastatic malignancy.
  • patients with cardiopulmonary diseases.

结局指标

主要结局

Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal).

时间窗: Rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) in the first month after operation

Compare the rate of postoperative anastomosis leakage(pancreatic,billary and intestinal) between the open and laparoscopic assisted pancreaticoduodenctomy

post operative pain.

时间窗: Compare the post operative pain between open and laparoscopic assisted pancreaticoduodenctomy in the first week after operation

Compare the post operative pain betweenopen and laparoscopic assisted pancreaticoduodenectomy

Blood loss

时间窗: Compare the intra operative blood loss between open and laparoscopic assisted pancreaticoduodenectomy during the operation

Compare between the intra operative blood loss in the open and laparoscopic assisted pancreaticoduodenectomy

次要结局

  • Postoperative 30 days mortality rate.(In the first 30days after operation)
  • Postoperative haemorrhage(In the first 2 weeks)
  • Starting oral feeding(In the first 3 days after operation)
  • Postoperative wound infection.(In the first 2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Aly

assistant lectuerer

Assiut University

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