Does the Management of Anastomotic Leakage After Low Rectal Resection Affect the Long-term Oncological Outcome: A Retrospective Propensity Score Adjusted Cohort Study
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
- 否
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
Ignazio Tarantino
Senior Physician
Cantonal Hospital of St. Gallen
