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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04856995
Other study ID # AIBU-SBF-GES-02
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 12, 2020
Est. completion date July 20, 2020

Study information

Verified date April 2021
Source Abant Izzet Baysal University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study; It was planned to (1) determine the effect of surgical smoke on indoor air quality and (2) examine its effect on physical symptoms and throat culture results in operating room employees and compare it with those working in internal units.


Description:

Background:This study is a experimental study. The aim of this study is; to determine the effect of surgical smoke containing toxic chemicals on indoor air quality and to examine the physical symptoms of employees in the operating room. Method:It was carried out in general surgery operating room between June 2020 and July 2020 In the study, 45 air samples were taken from the with active sampling method before, during and after surgery. Physical complaints of 19 people working in the operating room were asked and throat cultures were taken before and after surgery. These results were compared with those working in internal units. Data were analyzed using a statistics program.


Recruitment information / eligibility

Status Completed
Enrollment 29
Est. completion date July 20, 2020
Est. primary completion date July 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Health workers in operating room Exclusion Criteria: - those with chronic diseases such as Chronic Obstructive Pulmonary Disease, Asthma

Study Design


Intervention

Other:
exposure to surgical smoke during surgery
No intervention was made. During the surgery, complaints and throat cultures were taken before and after exposure to surgical smoke. Simultaneously, 45 air samples are taken in the operating room before, during and after the operation.

Locations

Country Name City State
Turkey Bolu Abant Izzet Baysal Üniversitesi/Saglik Bilimleri Fakültesi Bolu

Sponsors (1)

Lead Sponsor Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

Choi SH, Kwon TG, Chung SK, Kim TH. Surgical smoke may be a biohazard to surgeons performing laparoscopic surgery. Surg Endosc. 2014 Aug;28(8):2374-80. doi: 10.1007/s00464-014-3472-3. Epub 2014 Feb 26. — View Citation

Ilce A, Yuzden GE, Yavuz van Giersbergen M. The examination of problems experienced by nurses and doctors associated with exposure to surgical smoke and the necessary precautions. J Clin Nurs. 2017 Jun;26(11-12):1555-1561. doi: 10.1111/jocn.13455. Epub 2017 Mar 20. — View Citation

Okoshi K, Kobayashi K, Kinoshita K, Tomizawa Y, Hasegawa S, Sakai Y. Health risks associated with exposure to surgical smoke for surgeons and operation room personnel. Surg Today. 2015 Aug;45(8):957-65. doi: 10.1007/s00595-014-1085-z. Epub 2014 Nov 25. Review. — View Citation

Tramontini CC, Galvão CM, Claudio CV, Ribeiro RP, Martins JT. [Composition of the electrocautery smoke: integrative literature review]. Rev Esc Enferm USP. 2016 Feb;50(1):148-57. doi: 10.1590/S0080-623420160000100019. Review. Portuguese. — View Citation

Ulmer BC. The hazards of surgical smoke. AORN J. 2008 Apr;87(4):721-34; quiz 735-8. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary AIR UALITY IN OPERATING ROOM Surgical smoke contains cellular materials including polycyclic aromatic hydrocarbons (PAH) and volatile organic compounds (VOC) from carcinogenic chemicals.In the study, 45 air samples were taken from the general surgery operating room with active sampling method before, during and after surgery 29/06/2020- 20/07/2020
Primary THE PHYSICAL SYMPTOMS Physical complaints of 19 people working in the general surgery operating room were asked and throat cultures were taken before and after surgery. These results were compared with those working in internal units. 29/06/2020- 20/07/2020
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