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临床试验/NCT01191138
NCT01191138已完成不适用

Randomized Control Trial Comparing Gastric Emptying Following Infracolic vs Supracolic Gastrojejunostomy After Whipples Pancreaticoduodenectomy

Asian Institute of Gastroenterology, India2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Gastric Emptying assessed clinically and correlated objectively with liquid and solid emptying of radionucleotide

研究概览

简要总结

Patients undergoing whipples pancreaticoduodenectomy tend to develop delayed gastric emptying.

The study compares two types of anastamosis of stomach to jejunum (supracolic and infracolic) and compares whether it influences the gastric emptying.

The clinical evidence of delayed gastric emptying is correlated with objective evidence of liquid and solid emptying by radionuclide study.

The study also tries to evaluate whether pancreatic leak correlates with delayed gastric emptying

详细描述

METHODOLOGY:

This randomized control trial includes all patients undergoing whipples pancreaticoduodenectomy st Asian Institute of Gastroenterology. All patients were randomized by a closed envelope technique. The envelope was opened after complete resection of the specimen and then allocating the patients into either of the two groups, Group A- Infracolic Gastrojejunostomy, Group B- Supracolic Gastrojejunostomy.

Inclusion Criteria:

  • All patients undergoing whipples pancreaticoduodenectomy, who consented for the trial and found to be resectable at surgery.

Exclusion Criteria:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing Whipples procedure

排除标准

  • Unresectable tumors at surgery
  • Postoperative mechanical obstruction
  • Postoperative mortality, where the test could not be done

结局指标

主要结局

Gastric Emptying assessed clinically and correlated objectively with liquid and solid emptying of radionucleotide

时间窗: 30 days after surgery

Gastric emptying in the postoperative period in the form of tolerence of food and removal of ryles tube is assessed. This is correlated with liquid and solid emptying of radionucleotide

次要结局

  • Correlation of pancreatic duct leak with gastric emptying(30 days after surgery)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other

研究点 (2)

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