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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03425175
Other study ID # EPN 2017/247
Secondary ID
Status Completed
Phase N/A
First received January 24, 2018
Last updated January 31, 2018
Start date August 29, 2017
Est. completion date September 28, 2017

Study information

Verified date January 2018
Source Region Örebro County
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

In september 2017 audio recording during laparoscopic general surgery was implemented as routine a Lindesbergs hospital. The study was designed to observe operations before and after the introduction of audio recording. The main outcome of the study was time spent on non-relevant conversation.


Description:

In september 2017 audio recording during laparoscopic general surgery was implemented as routine a Lindesbergs hospital. One single observer not working at the department observed consecutive operations before and after the introduction of audio recordings. All elective laparoscopic procedures were included. There was no available data to support a Power-calculation why we intended to include 20 patients in each arm of the study. Exclusion criteria were refusal of operating team or patient to participate in the study, or planned open surgery. Potential disturbances were recorded by the observer. The main outcome was time with non-relevant conversation (for the operation or as part of education).


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date September 28, 2017
Est. primary completion date September 28, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Elective laparoscopic general surgery -

Exclusion Criteria:R, planned open surgery, refusal to participate (patient or operating team)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Audio-recoring
Recording of audio through microphone carried bu surgeon and assistant surgeon

Locations

Country Name City State
Sweden Lindesbergs Hospital Lindesberg

Sponsors (2)

Lead Sponsor Collaborator
Region Örebro County Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Non-relevant conversation Time spent on non-relevant conversation Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Secondary Postoperative complication complication occuring within the first 30 Days after surgery 30 days after surgery
Secondary Intraoperative unplanned event Any deviation from expected events during the surgical procedure Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Secondary Corrections of assistant surgeon number of corrections of assistant surgeon made by the operating surgeon Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Secondary Operation time Length of operation Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
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