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临床试验/NCT06924931
NCT06924931已完成不适用

Five-year Recurrence and Postoperative Complications After Laparoscopic Complete Mesocolic Excision- a Population-Based, Multicentred Study

Gødstrup Hospital0 个研究点目标入组 2,529 人开始时间: 2015年1月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,529
主要终点
Recurrence

研究概览

简要总结

A register-based study is conducted to examine clinical outcomes following a population-based, multi-centred implementation of Laparoscopic Complete Mesocolic Excision (LCME) in the Central Denmark Region, Denmark.

详细描述

This study was conducted as a population-based "before-and-after" cohort study following the implementation of LCME in the Central Denmark Region (CDR), Denmark, in 2017. The IDEAL framework (Idea, Development, Evaluation, Assessment, Long-term) was used for examining the outcome of a training program on the LCME adoption.

Training programme A LCME training program was conducted from March 2017 to October 2017 in the CDR, inspired by the National English Laparoscopic Colorectal Surgery Course.

Patients This study included all colon cancer patients undergoing a curative-intent bowel resection in the defined timeframe. Exclusion criteria comprised: 1) another synchronous colon cancer; 2) metastatic disease at the time of surgery; 3) non-curative procedures or local resections only; 4) Danish residency <10 years preoperatively; and 5) non-colon primary cancer.

Data sources The DCCG database, a national registry of newly diagnosed colon cancer patients, was used to identify the primary cohort. For follow-up data beyond 30 days after surgery, the cohort was linked to the following registries: 1) the Danish Civil Registration System (DCRS), 2) the Danish Cancer Registry (DCR), 3) the Danish National Patient Registry (DNPR), 4) the Danish Pathology Registry (DPR) and the Danish Pathological Data Bank (DPDB).

Outcome The primary outcome was the cumulative incidence of colon cancer recurrence 5 years after surgery. A validated algorithm was used to identify recurrence.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • newly diagnosed colon cancer patients.

排除标准

  • another synchronous colon cancer
  • metastatic disease at the time of surgery
  • non-curative procedures or local resections only
  • Danish residency <10 years preoperatively
  • non-colon primary cancer.

结局指标

主要结局

Recurrence

时间窗: From surgery to date of recurrence or end of 5-years follow up.

The cumulative incidence of colon cancer recurrence 5 years after surgery.

次要结局

  • mortality(From surgery to the date of mortality or end of 5-years follow-up.)
  • postoperative complications(30 days after primary surgery)

研究者

发起方
Gødstrup Hospital
申办方类型
Other
责任方
Sponsor

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