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临床试验/NCT06758934
NCT06758934已完成不适用

Comparison of Textbook Outcomes Between Laparoscopic and Open Total Gastrectomy for Gastric Cancer

Bakirkoy Dr. Sadi Konuk Research and Training Hospital1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2024年8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
94
试验地点
1
主要终点
Textbook Outcome

研究概览

简要总结

Gastric cancer patients underwent total gastrectomy with curative intent between in a single center were included in this retrospective study. Patients divided to two groups as open and laparoscopic groups and compared in terms of demographic data, tumor characteristics, operative data and textbook outcome

详细描述

Gastric cancer patients underwent total gastrectomy with curative intent between July 2018 and January 2024 in a single center were included in this retrospective observational study. Enrolled patients divided to two groups as open total gastrectomy (open group) and laparoscopic total gastrectomy (lap group).

Data of patients obtained via the hospital software system. Demographic data, body mass index(BMI), Charlson comorbidity index (CCI) score and baseline characteristics, operative and postoperative results, tumor characteristics and textbook outcome results were investigated. Postoperative complications were pancreatic fistula, pleural effusion, pneumonia, anastomotic leak, intraabdominal abscess, surgical site infection, postoperative ileus.

All patients were already curative surgery patients and underwent total gastrectomy and D2 lymphadenectomy. Apart from this, the list of criteria for a patient who had a textbook outcome was as follows: no intraoperative complication, achievement of tumor-negative margins, including ≥15 harvested lymph nodes in resected specimen, no severe postoperative complication(Clavien-Dindo Score≥3, (CD)), no reintervention, no readmission to intensive care unit after once coming to the surgical ward, no prolonged hospital stay (≤21 days), no postoperative mortality (30 days) and no readmission after discharge from the hospital

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • Gastric cancer patients underwent total gastrectomy with curative intent

排除标准

  • Emergency surgery,
  • Recurrent disease
  • Metastatic disease,
  • Conversion to open surgery,
  • Robotic gastrectomy.

结局指标

主要结局

Textbook Outcome

时间窗: 30 days

The criteria required for a patient who underwent total gastrectomy to have reached a textbook outcome are as follows: * no intraoperative complication, * achievement of tumor-negative margin, * including ≥15 harvested lymph nodes in resected specimen, * no severe postoperative complication(Clavien-Dindo Score≥3, (CD)), * no reintervention, * no readmission to intensive care unit after once coming to the surgical ward, * no prolonged hospital stay (≤21 days), * no postoperative mortality (30 days) and * no readmission after discharge from the hospital

次要结局

未报告次要终点

研究者

发起方
Bakirkoy Dr. Sadi Konuk Research and Training Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Turgut Donmez

Ass. Prof. Dr.

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

研究点 (1)

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