NCT04880915

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 11, 2021

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

April 24, 2021

Last Update Submit

May 10, 2021

Conditions

Keywords

Surgical smokeoperating roomemployee safetynursing

Outcome Measures

Primary Outcomes (2)

  • Investigation of the preoperative and postoperative blood samples on Surgical Smoke Protection-Experimental Study

    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. Blood and urine samples were collected from surgical team before and after surgery. Blood samples were evaluated in the laboratory for volatile organic compound (benzene, toluene, xylene and styrene etc.)

    "an average of 6 month"

  • Investigation of the preoperative and postoperative urine samples on Surgical Smoke Protection-Experimental Study

    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. Blood and urine samples were collected from surgical team before and after surgery. The urine samples were evaluated volatile organic compound (in terms of urinary metabolites benzene-phenol-TT muconic acid, toluene-hippuric acid-O, cresol, xylene-hippuric acid and phenol-phenol etc.) in the laboratory.

    "an average of 6 month"

Study Arms (1)

SMOKE PROTECTION

EXPERIMENTAL

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. 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 \[7 volunteers × 2 (blood and urine before and after surgery) = 14 (14 blood analysis + 14 urine analysis) 14 × 5 surgery = 70 (70 blood analysis + 70 urine analysis)\].

Other: surgical smoke affects

Interventions

The study, experimental type, was conducted to investigate the effects of five different methods on surgical smoke protection.

Also known as: blood and urine samples
SMOKE PROTECTION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Working in the operating room and smoke exposure during total mastectomy surgery
  • Agree to participate in the study,

You may not qualify if:

  • Working in the other operations
  • Not wanting to give blood or urine sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Izmir, Bornova, 35100, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Burcak Sahin Koze, Mscn

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 24, 2021

First Posted

May 11, 2021

Study Start

August 1, 2018

Primary Completion

February 25, 2019

Study Completion

September 3, 2019

Last Updated

May 12, 2021

Record last verified: 2021-05

Locations