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临床试验/NCT04481828
NCT04481828已完成不适用

Comparison With Open and Totally Laparoscopic Gastrectomy for Gastric Cancer in a Low Volume Center

Kocaeli Derince Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年1月最近更新:
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
1
主要终点
Previous abdominal surgery status

研究概览

简要总结

In gastric cancer, laparoscopic gastrectomy is commonly performed in Asian countries. In other regions where tumor incidence is relatively low and patient characteristics are different, developments in this issue have been limited. In this study, the investigators aimed to compare the early results for patients who underwent open or laparoscopic gastrectomy for gastric cancer in a center in Turkey.

详细描述

The patients who were operated in Kocaeli Derince Training and Research Hospital between January 2014 and January 2019 consecutively due to gastric cancer were analyzed. The diagnosis was made by upper gastrointestinal endoscopy and endoscopic biopsy. Clinical staging was done using contrast computed tomography (CT). Positron emission tomography (PET) was used in patients with suspected metastasis.The patients were divided into two groups according to the technique applied (open, laparotomy). The first group (Group 1; n: 30) consisted of patients who underwent open surgery, and the second group (Group 2, n: 30) laparoscopic surgery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Gastric cancer(adenocarcinoma) proven biopsy
  • Operated by same surgical team
  • Presence of distant metastasis

排除标准

  • Patients who underwent palliative resection
  • operated by a different surgical team
  • ASA score: 4

结局指标

主要结局

Previous abdominal surgery status

时间窗: 2014-2019

yes or no

Comorbidity status

时间窗: 2014 -2019

present or absent

Neoadjuvant therapy status

时间窗: 2014-2019

present or absent

American Society of Anesthesiologists (ASA) score

时间窗: 2014-2019

1,2,3,4

Body mass index

时间窗: 2014- 2019

kg/m2

Gender

时间窗: 2014-2019

male or female

Surgical technique

时间窗: 2014-2019

open or laparoscopic

Operation time

时间窗: 2014 - 2019

minute

Complication (Clavien-Dindo Classification)

时间窗: 2014 - 2019

1,2,3 A,3 B,4 A,4 B,5 (according to Clavien-Dindo Classification)

Age

时间窗: 2014-2019

year

Tumor localization

时间窗: 2014 - 2019

proximal, middle, lower

Gastrectomy type

时间窗: 2014 - 2019

total, subtotal

Lymph node dissection type

时间窗: 2014 - 2019

D1+, D2

Blood loss

时间窗: 2014 - 2019

ml

30-day mortality

时间窗: 2014 - 2019

present or absent

Number of harvested lymph node

时间窗: 2014 - 2019

number

Resection margin status

时间窗: 2014 - 2019

positive or negative

Tumor stage (American Joint Committee on Cancer 8th Edition)

时间窗: 2014 - 2019

0,1,2 A,2 B,3,4 A, 4 B (According to American Joint Committee on Cancer 8th Edition)

次要结局

未报告次要终点

研究者

发起方
Kocaeli Derince Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Adem Yuksel

M.D. Department of Gastroenterological surgery,Principal Investigator

Kocaeli Derince Education and Research Hospital

研究点 (1)

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