SSIs are a common problem in the healthcare system . They lead to an increased mortality and morbidity rate. Apart from the negative impact on patients, SSIs cause high healthcare costs due to prolonged hospital stay and readmission of patients. Colorectal surgery, in particular, is associated with a high infection rate ranging from 15% to 30% [2, 3].
In order to understand the causes of SSIs, risk factors have to be evaluated. Intrinsic and extrinsic factors have previously been defined . Intrinsic risk factors are patient-associated and can be subclassified in modifiable and non-modifiable features. Modifiable intrinsic risk factors include diabetes, alcoholism, smoking status, obesity and preoperative albumin level. Examples of non-modifiable risk factors include age and recent radiotherapy. Extrinsic risk factors are procedure-related and involve emergency surgeries or facility risk factors. There are several strategies to prevent SSIs. The biggest impact has been found in the combination of different measures into a bundle of care [5, 2, 6].
The Cantonal Hospital Lucerne (LUKS) is an 870-bed public acute care teaching hospital serving a population of about 500.000 people in central Switzerland. From October 2016 till September 2017 the rate of SSIs in colorectal surgery in LUKS was 18.1% whereas the average rate of SSIs in Switzerland was 13.7% during the same period of time . These nationwide data were collected and analyzed by Swissnoso, an organization monitoring SSIs cross-disciplinary.
In order to reduce the SSIs at LUKS, we created a colorectal bundle containing 9 measures. These measures were based on a literature research and selected in cooperation with the Department of Hospital Infection Control.
This prospective observational monocentric study will commence at LUKS, a large non-university hospital in Switzerland. A total of 150 patients will be included between January 2021 and December 2021. Ethical approval has been obtained from the responsible Swiss Ethics Committee (EKNZ) with the project ID: 2020–00051. The study is registered at ClinicalTrials.gov with the number NCT04677686.
All patients undergoing colorectal surgery from January 2021 until December 2021, fulfilling the inclusion criteria and having signed an informed consent form will be included in the study. According to our annual case load, we expect to enroll about 150 patients in the study. The data of the patients which are prospectively included in this study will be compared with the data analyzed by Swissnoso (October 2017–September 2018 and October 2018–September 2019). From 2017–2018 153 patients were included and 31 infections were detected (5 superficial, 8 deep and 18 involving the abdominal cavity).
From 2018–2019 after partial implementation of the colorectal bundle actions 126 were included and 15 infections occurred (2 superficial, 4 deep and 9 involving the abdominal cavity). Concerning the three time periods, data acquisition is retrospective for the first two periods and prospective for the final period.
All patients aged 18 years or older undergoing elective or emergency colorectal surgery from January 2021 until December 2021 will be included in the study. Written informed consent will be obtained. Patients under 18 years of age, pregnant patients or patients who refuse or are unable to give informed consent due to mental status, will be excluded from the study.
In our study protocol we defined three time periods in order to evaluate the effectiveness of our colorectal bundle. We collected data and analyzed the SSI rate from October 2018 till September 2019, before our bundle was implemented. From October 2019 till September 2020, a first set of measures was established. Therefore, this time period is defined as “during implementation”. In January 2021 the full extent of our colorectal bundle was implemented and the time period “after implementation” started for one year.
Following measures were defined based on a current literature review.
As previously mentioned, our colorectal bundle was implemented gradually over a time period of three years. In the following, a detailed implementation plan is listed.
During this time period, 137 patients underwent colorectal surgery. Only basic measures for preventing SSI were performed:
During this phase, additional measures have been introduced:
During this phase, additional measures are being implemented.
The primary endpoint of this study is occurrence of SSI within 30 days after surgery. Evaluation of risk factors for SSI will be secondary endpoints. In Table 1, the patient-associated risk factors and procedure-associated risk factors assessed in our study protocol are listed.
|PATIENT ASSOCIATED RISK FACTORS||PROCEDURE ASSOCIATED RISK FACTORS|
|Age||Date of the operation?|
|Sex||Duration auf the operation (min)|
|Diagnosis||What kind of operation was performed?|
|Weight||Which technique of surgery was done (open, laparoscopic, robotic)?|
|Fat tissue measured in CT scan||Which type of stoma was inserted?|
|Diabetes and what kind of diabetes|
|Immune-deficiency diseases and which type of disease exactly|
|Immunosupressive drugs and which ones|
|Length of hospitalization|
|Contamination Class of wounds|
Moreover, we measure pre-albumin levels to determine the nutritional status. We assess whether immune-modulatory supplements like Oral Impact® have been given before surgery. We include the ASA (American Society of Anesthesiologists) score in our data to define the general health status of the patient. Furthermore, we classify the grade of contamination of the wound prior to surgery.
After the operation, we assess compliance by evaluating whether the nine measures of our colorectal bundle of care were performed as planned. If SSIs occur, we classify them and treat them according to the guidelines. Patients will be followed for the occurrence of SSIs within 30 days after surgery by means of a telephone survey. These telephone surveys have also been done during the pre-implementation and implementation phase. Our goal-directed questions enable patients to recognize symptoms suspicious of a SSI at home. Criteria for wound infection comprise redness and pain around the wound, drainage from cloudy fluid, fever, wound dehiscence, etc. If patients report suspicion of SSI, we strongly advise them to present themselves at our outpatient clinic or at the family doctor for evaluation and treatment.
Data will be presented as absolute and relative frequencies for categorical variables and using descriptive statistics for continuous variables.
The primary endpoint, occurrence of SSI within 30 days after surgery, will be determined as a rate (number of patients experiencing SSI/number of patients undergoing colorectal surgery). The SSI rate will be determined together with a 95% confidence interval according to Clopper-Pearson.
The SSI rate will be compared to the SSI rates obtained for previous years (pre-implementation phase implementation phase) in an unadjusted manner as well as after adjustment for NNIS risk index. The NNIS risk index will be applied according to the methodology of Swissnoso and is based on ASA score, surgical wound classification and duration of surgery.
Potential risk factors of SSIs will be evaluated in an exploratory manner by measures of association and utilizing logistic regression models.
The sample size in this observational study is based on the expected number of patients undergoing colorectal surgery annually. With approx. 150 patients, the half-width of the 95% confidence interval for the SSI rate will not exceed 6.5% as long as the SSI rate is not greater than 18%.
The Swiss Ethics Board has approved the trial’s protocol version 2, dated 21 April 2020. The trial will be performed according to the ethical protocol and the current version of the World Medical Association Declaration of Helsinki and the International Conference on Harmonization Gool Clinical Practice (ICH GCP) guidelines.
SSIs are a major challenge in patient care after colorectal surgery. A high number of SSIs leads to an increase in hospital length of stay, readmission rates, and healthcare costs . Over the last years, several studies have shown that the combination of multiple SSI reduction measures into a bundle can significantly reduce SSI rates . The impact of the individual measure and thus the “right” combination of a bundle of care for a single institution remains unclear .
The rate of SSIs is considered as quality factor for surgical care and thus we aimed to improve outcome quality with the implementation of a bundle of care in colorectal surgery at our institution. Since a variety of risk factors contribute to SSIs, it is widely believed that improvement cannot be achieved by one single action, even though each single action has been shown to reduce SSIs significantly in former studies. As a consequence, the implementation of a bundle of measures is necessary. Nevertheless the effectiveness and moreover the achievability of compliance and adherence to all these measures by a multidisciplinary team, is still under discussion. On the one hand, the positive effect of reduction of SSIs has been demonstrated in former studies . On the other hand, some studies have shown that although every single action has a high level of evidence the bundle of care itself cannot reduce the rate of SSIs [22, 23, 24].
In our institution, an increasing number of SSIs in patients undergoing colorectal surgery could be observed over the last years. To improve patients` outcomes a colorectal bundle of care was gradually implemented over three years as a monocentric, prospective observational study.
To address and prevent malcompliance in a large multidisciplinary team repetitive instructions and trainings have been performed and for each action and team respectively a separate checklist was created. In addition, we plan meetings with the responsible team members on a monthly basis to update and raise awareness.
Several bundles with numerous separate actions have been described in literature. We have reflected our workflows and selected a comparatively high number of nine measures, which should be most effective in our setting to decrease the rate off SSIs. Regular information and instruction of all the involved teams and the rising of awareness towards this topic, can lead to behavioral changes contributing to a decrease of SSIs.
Our study has some limitations that have to be acknowledged. First of all this is a single-center study. We assume that the bundle will lead to a decrease of SSIs in our institution, but whether our measures can be applied successfully in other institutions, is difficult to predict. Secondly, the value of each individual measure is difficult or impossible to evaluate and this poses a problem in the interpretation of the effects of a whole bundle of care. Thirdly, our study has three periods of implementation of the measures of the colorectal bundle; while two periods were analyzed retrospectively, data of the main study period is acquired prospectively. Lastly, since different measures and combinations of measures are used in different bundles, comparability in literature is limited.
Besides analyzing the effects of our colorectal bundle on SSIs, we aim to investigate the impact of risk factors like smoking habits, alcoholism, weight, etc. and their combination.
This investigation is part of a quality improvement project to reduce SSIs and their consequences for the patients and the whole healthcare system.
Originally the timelines were from October 2020 to September 2021, but due to the Corona pandemic we had to alter the timeline from January 2021 to December 2021.
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
The Institutional Review Board has approved the study and patient enrollment started in January 2021. Currently (first 8 months) ca. 50 patients could be included into the study successfully. According to our study protocol the last patient will be enrolled on December 31st 2021.
All participants have given consent for publication of the anonymous data by giving written and spoken “informed consent” in the context of the study inclusion.
There is no funding. This study is financed by the Department of General and Visceral Surgery of the Cantonal Hospital of Lucerne.
The authors have no competing interests to declare.
SB, JL, JMG designed the study. JMG acted as trial coordinator. SB, JL, LF, JM, AS, IZ and JMG drafted the manuscript. Statistical analysis were carried out by DL. All authors have read and approved the final manuscript.
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