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临床试验/NCT06059924
NCT06059924已完成不适用

Does the Management of Anastomotic Leakage After Low Rectal Resection Affect the Long-term Oncological Outcome: A Retrospective Propensity Score Adjusted Cohort Study

Cantonal Hospital of St. Gallen1 个研究点 分布在 1 个国家目标入组 941 人开始时间: 1991年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
941
试验地点
1
主要终点
Cancer-specific survival

研究概览

简要总结

The aim of this retrospective cohort-study is to assess the effects of AL and its severity divided according the ISREC-classification on the long-term oncological outcome.

详细描述

Rectal cancer is one of the most common malignancies in the world. Its costs and cancer-related mortality are increasing worldwide. The surgical treatment was revolutionized in recent years by the total mesorectal excision (TME) technique as well as the laparoscopic, robotic, and transanal approach. But anastomotic leakage (AL) remains one of the most feared complications after low rectal resection regarding postoperative morbidity and mortality as well as functional outcome. Several risk factors causing AL like low level of anastomosis, large tumor mass, male gender, smoking, perioperative bleeding, and preoperative radio-chemotherapy are known. Protective ileo- or colostomy formation and transanal tube placement may decrease the risk of AL and reduces the rate of reoperation due to AL. Diverting results of the association between AL and the long-term oncological outcome (local recurrence, systemic recurrence, survival) are described in the current literature.

The International Study Group of Rectal Cancer (ISREC) provides a classification of AL according to its clinical management:

  • Grade A results in no change in patient's management
  • Grade B requires active therapeutic intervention without re-laparotomy
  • Grade C requires re-laparotomy

This classification allows a good stratification regarding postoperative morbidity and mortality. However, the association between the ISREC-classification of AL and the long-term oncological outcome is not yet clear.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients receiving elective low anterior resection (LAR) between February 1991 and December 2020 at the Cantonal Hospital of St. Gallen

排除标准

  • Other diagnosis than rectal cancer
  • Discontinuity resection (no anastomosis)
  • Emergency situation
  • R1-resection
  • Incomplete staging
  • Metastatic cancer
  • 30-day mortality
  • Decline of a retrospective data analysis
  • Secondary malignancy
  • Age under 18 years

结局指标

主要结局

Cancer-specific survival

时间窗: 30 days postoperative to 5 years postoperative

次要结局

  • Recurrence-free survival(30 days postoperative to 5 years postoperative)
  • Overall survival(30 days postoperative to 5 years postoperative)
  • Disease-free survival(30 days postoperative to 5 years postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ignazio Tarantino

Senior Physician

Cantonal Hospital of St. Gallen

研究点 (1)

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