lymfleakage postoperative wound infection seroma formation Surgical site infection (SSI)
Conditions
Interventions
The use of Ligasure for cut down in the groin for exposure of the femoral
arteries
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients undergoing an inguinal approach of the femoral arteries. Patients older than 18 years and competent. Patients have to be able to comprehend the patient information. Filling out, signing and returning of the informed consent form.
Exclusion criteria
Exclusion criteria: The use of mono-polair coagulation is contra-indicated Patients not giving informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameter/endpoint: Surgical site infections Measuring instrument surgical site infection The Szilagyi classification, classifies surgical site infection from vascular prosthesis based on the depth of the infection. The infection can be assigned to one of three groups: group 1) dermis, group 2) subcutaneous, but not involving the prosthetics and group 3) prosthetics involved in the infection (Szilagyi, Smith, Elliott & Vrandecic, 1972). As it concerns a vascular surgical population and as prosthetic material may be involved, this classification system will be used additionally in case of an infection (measurement level ordinal). In order to improve reliability, various instruments will be used to measure postoperative wound infection. *Surgical site infection of the area operated upon are categorized as follows: - Superficial postoperative wound infections - Deep postoperative wound infections - Organ or anatomical space infections, which organs or anatomical spaces have been opened or manipulated during the procedure* (National Institute for Health and Environment, 2018, p. 4). Based on this classification and on the registration instructions of the National Institute for Public Health and the Environment (2018), a measuring instrument has been developed for surgical site infection that can be used by the researchers during the measurement moments (measurement level ordinal). As wound management policy is not included in the results, wound management policy is standardized on the basis of wound care guidelines (Nederlandse Vereniging voor Heelkunde, 2013), literature on surgical and traumatic wounds by Groetelaers & Van Ruitenberg (2015) and the WCS classification model to secure the reliability and validity of the research (the same researcher signature). The WCS classification model is a tool to determine the local wound management objectives and to determine the correct wound management product (Vermeulen, Schreuder, Lubbe | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameter/endpoint: Pain and quality of life. Measuring instrument quality of life EQ-5D-3L Quality of life can be measured using the EuroQol Group's measuring instrument EQ-5D. This is a standardized measuring instrument applicable in various health conditions and treatments. It is used, inter alia, in clinical trials. The effects of treatment can thus be evaluated. In addition, longitudinal data collected with the EQ-5D can be used on an individual level to monitor the patient's health status over time. (Szende, Janssen & Cabases, 2014). The EQ-5D-3L version was introduced by the EuroQol group in 1990. It consists of two parts. First, the patient is invited to score five levels of health, being the health status of mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Per health status, the patient chooses one out of three possible answers (measurement level nominal and ordinal). Next is the visual analogue scale (EQ VAS). Here, the patient can indicate how well or badly his or her current health is experienced. The measuring scale ranges from 0 to 100, with 100 representing the best health level imaginable to the patient. The EQ VAS is used as a quantitative measuring instrument (measurement level ratio). The patient is intended to fill out the measuring instrument him/herself within a few minutes. EuroQol is complementary to other measuring instruments regarding quality of life. Various studies have shown that the EQ-5D-3L is a reliable and valid measuring instrument, capable of measuring quality of life in a reproducible manner. (Brooks, 1996). Age, gender and educational attainment are included as variables in the measuring instrument EQ-5D-3L. Measuring instrument with regard to pain The most frequently mentioned definition of pain stems from the International Association for the Study of Pain (IASP, 1994): *An unpleasant sensory and emotional experience associated with actual or potential tis | — |
Countries
Netherlands
Outcome results
None listed