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临床试验/NCT06281379
NCT06281379已完成不适用

Short-term Results of a Randomized Controlled Trial and Review of the Literature Complete Mesogastric Excision With D2 Lympadenectomy for Gastric Cancer: Short-term Results of a Randomized Controlled Trial and Review of the Literature

Başakşehir Çam & Sakura City Hospital1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2023年4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
37
试验地点
1
主要终点
Postoperative outcome

研究概览

简要总结

Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population.

Study design:Randomised-controlled study

Place and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023.

Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature.

Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization.

详细描述

The curative treatment of gastrointestinal tumors is surgery referring to an en block resection of the primary tumor along with its lymphovascular drainage.Unfortunately, despite of these radical resections, published literature shows that recurrences occur in up to 38% of patients in 5 years. Morover, these rates may reach to 60% in patients with locally advanced tumor following radical surgery. However, this mesentery-based surgery is harder to apply in gastric cancer due to differences in embriyological development. In our prospective study and a review of the literature, following the descripiton of mesogastrium concept, we aimed to search and analyse former techniques and viewpoints about mesogastric excision by different surgical approaches from various countries. Later, we aimed to show our technique of mesogastrectomy, compared our short term results with limited publications from the literature.

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
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Patients with histopathologically confirmed gastric adenocancer without evidence of distal metastasis and resectable tumors which have been treated with open total gastrectomy.

排除标准

  • •Patients with prior upper gastrointestinal system surgery
  • •Patients with neoadjuvant therapy
  • •Patients with peripheral organ involvement and/or distant metastasis
  • •Patients who underwent subtotal gastrectomy
  • •Patients who underwent laparoscopic and robotic operations

研究组 & 干预措施

Group 1

Experimental

Total gastrectomy+mesogastrectomy

干预措施: Total mesogastrectomy (Procedure)

Group 2

Other

Total gastrectomy with concentional D2 lymphadenectomy

干预措施: Total mesogastrectomy (Procedure)

结局指标

主要结局

Postoperative outcome

时间窗: Postoperative 1 week

Complications

次要结局

未报告次要终点

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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