Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04880915 |
Other study ID # |
Experimental |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
August 1, 2018 |
Est. completion date |
September 3, 2019 |
Study information
Verified date |
May 2021 |
Source |
Ege University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Background: Electrosurgery is used in almost all surgeries. The entire surgical team working
in these operating rooms is exposed to surgical smoke. In the literature, there is no study
examining the direct effect of surgical smoke on operating room staff and involving the
entire surgical team in sampling.
Materials and Methods: This experimental-type study was conducted in the operating room of
the Department of General Surgery of a University Hospital. In the study, the surgeries were
completed with standard practice and four different protective measures that could affect
surgical smoke exposure. Blood and urine samples were collected from the surgical team before
and after the surgery. Consequently, 70 blood and 70 urine samples were collected. The
Wilcoxon signed-rank test was used to compare pre- and post-operative analyses.
Description:
2. MATERIALS AND METHODS 2.1 Design of the Study This was an experimental study. 2.2
Population and Sample of the Study Pre- and post-operative blood and urine samples of the
surgical team (surgeon, surgical resident, anaesthesiologist, scrub nurse, circulating nurse,
support staff and researcher), who worked in the standard practice, and the use of four
different preventive measures that may affect the surgical smoke exposure during total
mastectomy surgery in the operating room of the General Surgery Department of a University
Hospital between January 2019 and December 2019 created the sample of the study. During the
study process, the surgeon, scrub nurse, circulating nurse and researcher were ensured to be
the same people in each surgery. The surgical resident, anaesthesiologist, anaesthesia
technician and support staff included in the study did not consist of the same people due to
the change in the work schedules. Blood and urine samples were collected from a team of seven
people before and after surgery [7 volunteers × 2 (blood and urine before and after surgery)
= 14 (14 blood analysis + 14 urine analysis) 14 × 5 surgery = 70 (70 blood analysis + 70
urine analysis)].
2.3 Collection of Study Data 2.3.1 Data Collection Tools The Surgery Data Collection Form,
which was created by the researchers in line with the relevant literature (Romano et al.
2016, 2017, Ragde et al. 2014; Tseng et al. 2014, Lin et al. 2010, Hollmann et al. 2004) to
evaluate the information about the surgery, was used to collect the data. Other data
collection tools were the N95 and safety equipment, the RapidVac™ Smoke Evacuator system for
smoke evacuation, as well as the pencil type (smoke extractor) and smoke tubing evacuators.
2.3.2 Data Collection Method Blood and urine samples of the surgical team were collected
before the total mastectomy in five different situations listed below that may affect
surgical smoke exposure.
After the surgery is completed with routine applications (without taking any measures for
smoke evacuation), After completing the surgery with the use of special safety equipment (N95
mask, safety glasses and without any measures for smoke evacuation), After the evacuation of
the smoke caused by the surgery with a wall-mounted aspirator, After the evacuation of the
smoke caused by the surgery with a smoke tubing and After the evacuation of the smoke caused
by the surgery with a smoke evacuation pencil.
The blood samples were kept in a transport bag that maintained the temperature range between
2 and 4 °C until they reached the laboratory and kept at -20 °C for analysis. Blood samples
were evaluated in the laboratory for benzene, toluene, xylene and styrene.
Similarly, the urine samples were kept in a transport bag that maintained the temperature
range between 2 and 4 °C until they reached the laboratory and kept at -20 °C for analysis.
The urine samples were evaluated in terms of urinary metabolites benzene-phenol-TT muconic
acid, toluene-hippuric acid-O, cresol, xylene-hippuric acid and phenol-phenol in the
laboratory.
Blood and urine analysis in the study was performed by the Central Research Test and Analysis
Laboratory Application and Research Center of the university of this study.
2.3.3 Evaluation and Analysis of Data The study data was evaluated using the IBM SPSS
Statistics 25.0 Statistics program. The Wilcoxon signed-rank test was used to compare pre-
and post-operative analyses. Moreover, 0.05 was accepted as significant.
Gas chromatography/mass spectrometry was used for the analysis of blood and urine samples of
the surgical team.
2.4 Ethical Aspect of Study Permission (11.01.2018-E.11195) was obtained from the Clinical
Research Ethics Committee of the university of this study. Also, written permission
(29.01.2018-E27595) from the institution where the research was conducted as well as informed
written consent from the participants in the study were obtained.