Quality Check: Concordance Between Two Monitoring Systems for Postoperative Organ/Space Surgical Site Infections in Rectal Cancer Surgery. Linkage of Data From the Catalan Cancer Plan (CCP) and the Catalan Healthcare-associated Infections Surveillance Programme (VINCat).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11,367
- 试验地点
- 1
- 主要终点
- Rate of Organ-space surgical site infection
研究概览
简要总结
The Catalan Cancer Plan (CCP) undertakes periodic audits of cancer treatment outcomes, including organ/space surgical site infections (O/S-SSI) rates, while the Catalan Healthcare-associated Infections Surveillance Programme (VINCat) carries out standardized prospective surveillance of surgical site infections (SSIs) in colorectal surgery. This cohort study aimed to assess the concordance between these two monitoring systems for O/S-SSI following primary rectal cancer surgery.
详细描述
The healthcare system in Catalonia (Spain) monitors and reports SSI in cancer patients through two principal mechanisms. First of all, the Catalan Cancer Plan (CCP) is a Health Department structure that aims to improve the quality of care for cancer patients by means of periodic auditing of outcomes with real-world data and feedback to professionals. One indicator included in these compulsory audits is the occurrence of O/S-SSI.
On the other hand, the Catalan Healthcare-associated Infections Surveillance Programme (VINCat) is a nationwide network for hospital-acquired infections (HAI) which conducts surveillance in colorectal surgery.
The two systems thus operate with an important difference: the CCP audits are mandatory and cover all cancer surgeries performed in centres funded through the public healthcare system, while VINCat is a voluntary registry programme among participating centres. The selected cases and methods used to detect O/S-SSI may therefore vary substantially between auditing systems.
This retrospective population-based cohort study aims to assess the concordance between clinical audits of the CCP and the VINCat registry as a preliminary step to studies correlating local recurrence after rectal cancer surgery and O/S-SSI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 > 18 years old
- •Eligible patients with tumour ≤ 13 cm from anal verge, as measured by Magnetic Resonance Imaging
- •Primary adenocarcinoma
- •Oncological resection with curative intent
- •Cancer stages: I-II-III
排除标准
- •Transanal local resection
- •Emergency colorectal surgeries
- •Presence of metastases found in the diagnostic process or during the surgical procedure
- •Recurrence of the disease treated before the study period
- •Non-resectable tumour or palliative surgery
- •Patients operated in private centres
结局指标
主要结局
Rate of Organ-space surgical site infection
时间窗: 30 days
As described by the Centers for Disease Control: an infection occurring within 30 days of the surgical procedure and involves any part of the body deeper than the fascial/muscle layers that is opened or manipulated during surgery. In addition, the patient must present at least one of the following associated events: a purulent drainage from a drain placed into the organ/space
次要结局
未报告次要终点