Relevancy: Groin explorations are regularly performed procedures in vascular surgery. To date, the chosen technique will be either electrocoagulation or the Ligasure, depending on the operator*s preference. It is yet unclear whether the chosen…
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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, Lubbers & Ubbink, 2005). Wound management policy is
incorporated in the surgical site infection measuring instrument.
Secondary outcome
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 tissue damage, or
described in terms of such damage*. Pain is always subjective and consequently
every individual uses the word pain in relation to a previous experience with
an injury (Kumar & Elavarasi, 2016). Pain scoring systems have been developed
since the beginning of the last century. At first they were only used as
research instruments but over the last few decades increasingly as a clinical
parameter for monitoring and evaluating postoperative pain management.
To assess pain, the intensity of the pain can be measured by means of a
Numerical Rating Scale (NRS), one of the most widely used clinical methods
(Hartrick, Kovan & Shapiro, 2003). This is an aspecific measuring scale
consisting of eleven numbers ranging from zero to ten. Zero meaning no pain and
ten the most pain imaginable. The patient indicates the severity of his/her
pain by circling a number, which takes about a minute to complete. Since some
concentration, coordination and understanding of numbers is required, the NRS
is suitable for children from the age of eight onward (Von Baeyer, 2006) and
for elderly not cognitively impaired. (Ware, Epps, Herr & Packerd, 2006). In
recent research, Karcioglu, Topacoglu, Dikme and Dikme (2018) conclude that the
NRS is a valid, reliable, suitable and clinically usable measuring instrument.
In the Netherlands, the NRS is applied in accordance with the guidelines of the
handbook of VMSzorg (2009), which contains a standardized scheme for pain
measurement.
The NRS is used as an ordinal measuring instrument.
Background summary
There are various vascular surgeries in which artery exposure through the groin
(groin exploration) is necessary. Wound infections are relatively common in
groin explorations. Wound infection and lymphatic problems account for the
majority of wound complications in the groin (Ploeg, Lardenoye, Vrancken
Peeters, Hamming & Breslau, 2009). The surgical technique, including the degree
of tissue damage, the size of the wound bed, the use of foreign materials,
drains and the manner in which the surgery has been performed, are factors that
contribute to the development of SSIs (Infection Prevention Working Group,
2011).
In February 2019, a randomized control trial will start in the University
Medical Center of Groningen and Ommelander Hospital Groningen focusing on two
common surgical methods in vascular surgical operations, including groin
explorations. The methods differ in the use of techniques, being either
electrocoagulation or the Ligasure. Both these techniques are used to burn and
cut away tissue to reach the artery. Small blood vessels are cauterized. These
techniques differ in that the Ligasure has a constant pressure and intelligent
energy release (closed loop system). Tissue layers merge through the automatic
sealing process (Medtronic, 2018). The Ligasure indicates the completion of the
burn and by the electrocoagulation this is up to the vascular surgeon
him/herself.
Hypothesis
Applying the Ligasure in groin explorations will result in fewer postoperative
wound infections and seroma formation in comparison to the use of the standard
groin exploration using electrocoagulation, resulting in less pain and an
improved quality of life.
Study objective
Relevancy:
Groin explorations are regularly performed procedures in vascular surgery. To
date, the chosen technique will be either electrocoagulation or the Ligasure,
depending on the operator*s preference. It is yet unclear whether the chosen
technique has any influence on the occurrence of a SSI or seroma formation.
The research aim is to determine whether applying the Ligasure will lead to a
reduction of postoperative wound infections or seroma formation and thereby
will contribute to an improvement of quality of life and a reduction of pain in
comparison to the diathermy. The results of this research will elucidate
whether the Ligasure should be applied as the standard technique in groin
exploration.
Study design
This is a comparative, quantitative, longitudinal prospective study
(double-blind randomized controlled trial). Experimental, randomized,
double-blinded (for patients and nurse practitioner).
Intervention
The use of Ligasure for cut down in the groin for exposure of the femoral
arteries
Study burden and risks
Care as usual. There are no other potential risks or benefits than normally
associated with the surgery (postoperative wound infection and seroma
formation).
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
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
The use of mono-polair coagulation is contra-indicated
Patients not giving informed consent
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL66083.042.18 |