跳至主要内容
临床试验/NCT04496635
NCT04496635招募中不适用

Evaluation of the Application and Efficacy of Prevention Measures for Surgical Site Infection in Elective Colorectal Surgery.

Hospital de Granollers1 个研究点 分布在 1 个国家目标入组 60,000 人开始时间: 2007年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60,000
试验地点
1
主要终点
Surgical site infection rate

研究概览

简要总结

The Nosocomial Infection Surveillance Program in Catalonia (VINCat) monitors surgical site infection (SSI) in elective colorectal surgery since 2007 in 55 public and private acute care hospitals. These hospitals perform active and prospective standardized surveillance of elective colorectal resections. Post-discharge surveillance is mandatory at least up to 30 days after surgery. Hospitals are classified according to their size into three groups: >500 hospital beds; 200-500 beds; <200 beds.

Aim. To examine the effect on SSI rate of a specific preventative bundle in elective colorectal surgery.

Methods. Pragmatic study using VINCat prospective colorectal database from 2007 to 2018. In 2016, a bundle of six preventative measures was recommended to the VINCat hospitals.

To compare the results of SSI before (baseline phase, BP) and after the bundle implementation (implementation phase, IP) a logistic regression model has been established. The results will be shown as Odds Ratio (OR) and the corresponding confidence intervalsCI95. The significance level will be fixed at 5% (P < 0.05).

详细描述

Surveillance. The VINCat Program was developed in the 2007 as the Nosocomial Infection Surveillance system in Catalonia, covering a population of seven and a half million people. The system is similar to other international reference programs, such as the National Healthcare Safety Network (NHSN), and its described in detail on the VINCat website. Hospitals carry out active and prospective standardized surveillance, and are classified according to their number of beds into three groups: group 1 (500 beds); group 2 (200-500 beds); group 3 (200 beds). The staff performing surveillance had received training in the VINCat surveillance methodology to ensure the collection of homogeneous, accurate data.

Surveillance is continued at least for 30 days after the operation. All public and private participating hospitals report data voluntarily and receive feedback once a year.

Monitoring of colorectal surgery is performed prospectively and continued until a minimum of 100 interventions per year is reached in each hospital, although some centres include all their yearly cases. Hospitals with less than 10 interventions per year are excluded. Participating hospitals record the data on an Internet-based database.

Follow-up and post-discharge surveillance. Patients are followed up by trained infection control staff. Active mandatory post-discharge surveillance is performed at least to day 30 post surgery by a multimodal approach including electronic review of clinical records (primary and secondary care), checking readmissions, checking emergency visits, and reviewing microbiological and radiological data.

Development of the colorectal surgical site infection program. In 2015, a multidisciplinary team of nurses and medical specialists from the VINCat Program, and surgeons belonging to the Catalan Society of Surgery was set up to formulate a specific bundle of SSI preventative measures for colorectal surgery. The literature for optimal care during the preoperative, intraoperative and postoperative phases was reviewed, including evidence on oral antibiotic prophylaxis and mechanical bowel preparation. Practices were chosen either by their high levels of scientific evidence or by being considered, by consensus, reasonable, associated with minimal risk, and potentially beneficial.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Colon or rectal elective surgery.

排除标准

  • •Peritonitis at the time of intervention ("dirty" surgery) Patients who underwent multiple procedures during the same surgery, for example resection of liver metastases Centers that performed less tan 10 surgical procedures annually Centers that have not been able to ensure prospective surveillance during hospitalization or effective monitoring of cases within 30 days of the intervention

研究组 & 干预措施

Baseline phase

No Intervention

Patients included in the VINCat program, and operated on colorectal surgery between 2007 and 2015 in Catalonia

Implementation phase

Experimental

Patients included in the VINCat program, and operated on colorectal surgery between 2016 and 2018 in Catalonia

干预措施: Implementation of a bundle of care (Other)

结局指标

主要结局

Surgical site infection rate

时间窗: 30 days

Overall surgical infection rate

次要结局

  • Hospital type-Surgical infection rate(30 days)
  • Analysis (logistic regression model) of the efficacy of each preventive measure(30 days)
  • Organ/space surgical infection rate(30 days)

研究者

发起方
Hospital de Granollers
申办方类型
Other
责任方
Sponsor

研究点 (1)

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