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临床试验/NCT03757624
NCT03757624已完成不适用

TISSUE SHRINKAGE DEPENDS ON FORMOL SOLUTION IN DIFFERENT GASTRIC LOCATIONS

Fatih Sultan Mehmet Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
shrinkage in gastric tissue

研究概览

简要总结

Generally % 10 formol solution is use to do fixation to all specimens after the surgical operations for the pathological evaluation. It is known that the formol solution cause amount of shrinkage in the tissue volume . This effect of formol solution had researched in colon,breast and prostate previously. But there is no evidence about stomach. The purpose of this research is that find out the formol effect to the gastric tissue and detect the shrinkage percent.

详细描述

All gastric specimens which removed after Laparoscopic Sleeve Gastrectomy will open from the major curvature and spread down to the table.in operating room..3 cm x 3 cm three tissue samples will collect from the specific locations. These three locations are ; fundus( 1 cm from the top of staple line) , corpus (middle of the major curvature , antrum ( 1 cm far from the bottom of staple line ). All these points 5 mm far from the major curvature. 6 samples will prepare totally. 2 samples for each location ; one mucosa and one all layer of gastric wall for each location .These 3 points will examine about wall thickness(mucosa- submucosa-muscularis propria -serosa ) After saving the measurements in operating room;the gastric specimen will deliver to a pathologist to put the specimen into the % 10 formol solution. After 24 hours ;pathologist will save all of new measurements same in operating room. The measurements of sample are ;height , length , width . After the completion of the measurements the investigator will compare the results found in operating room in fresh specimen with pathologist 's results after formol. After that the investigator will be able to decide the shrinkage of gastric tissue in % 10 formol solution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

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
否

入选标准

  • •Patients older than 18 years old who will undergo to Laparoscopic Sleeve Gastrectomy

排除标准

  • •Patients who has to undergo another bariatric surgery type peroperatively
  • •Deformation of gastric specimen while removing from the abdomen

研究组 & 干预措施

Gastric specimen measurements after 24 hours from % 10 formol

Active Comparator

Gastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after formol solution

干预措施: shrinkage (Procedure)

Gastric specimen measurements after surgery in operating room

Active Comparator

Gastric specimens of patients who will undergo to Laparoscopic Sleeve Gastrectomy ,will examine after surgery in operating room peroperatively

干预措施: shrinkage (Procedure)

结局指标

主要结局

shrinkage in gastric tissue

时间窗: 24 hours

shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy

次要结局

未报告次要终点

研究者

发起方
Fatih Sultan Mehmet Training and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

ANIL ERGIN

asistant doctor

Fatih Sultan Mehmet Training and Research Hospital

研究点 (1)

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