NCT04856995

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2020

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
Last Updated

April 23, 2021

Status Verified

April 1, 2021

Enrollment Period

2 months

First QC Date

March 19, 2021

Last Update Submit

April 21, 2021

Conditions

Air QualityVolatile Organic CompoundsOccupational Health

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

working in the operating

operating room workers exposed to surgical smoke

Other: exposure to surgical smoke during surgery

working in internal units

Internal unit workers not exposed to surgical smoke

Interventions

exposure to surgical smoke during surgeryOTHER

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.

working in the operating

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Health workers in hospital

You may qualify if:

  • Health workers in operating room

You may not qualify if:

  • those with chronic diseases such as Chronic Obstructive Pulmonary Disease, Asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal Üniversitesi/Sağlık Bilimleri Fakültesi

Bolu, 14100, Turkey (Türkiye)

Location

Related Publications (5)

  • Ulmer BC. The hazards of surgical smoke. AORN J. 2008 Apr;87(4):721-34; quiz 735-8. doi: 10.1016/j.aorn.2007.10.012.

    PMID: 18461735BACKGROUND

  • 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.

    PMID: 25421864BACKGROUND

  • 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.

    PMID: 24570016BACKGROUND

  • Tramontini CC, Galvao 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. Portuguese.

    PMID: 27007432BACKGROUND

  • 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.

    PMID: 27345749BACKGROUND

Study Officials

  • GANİME E SOYSAL

    Abant Izzet Baysal University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

April 23, 2021

Study Start

May 12, 2020

Primary Completion

July 20, 2020

Study Completion

July 20, 2020

Last Updated

April 23, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will share

STUDY PROTOCOL Data collection process Determining the effect of surgical smoke on air quality Taking air samples in the general surgery operating room (n: 45) 1. Example: 45 minutes before the start of the operation 2. Example: 45 minutes from the beginning of the skin incision 3. Example: 45 minutes after the operations are over Determination of Physical Symptoms Caused by Surgical Smoke on Employees and Comparison Physicians and nurses in internal units control group(n: 20) Information Form Throat culture Case group (n: 19) Physicians and nurses exposed to surgical smoke in the general surgery operating room 1. Before starting the operation Information form Throat culture 2. After the surgery is over Information Form Throat culture

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
When article is published in the journal
Access Criteria
Article is published in the journal

Locations

TU(1)