Clinical trial NCT03425175: Audio Recording During Laparoscopic Surgery
Official title: Audio Recording During Laparoscopic Surgery - The Impact on Conversation Between Surgeons
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative/Postoperative Complications
Laparoscopy
Communication
Communication, Multidisciplinary
Keywords: Non-relevant conversation
Surgical safety
Audio recording
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Örebro University, Sweden
First posted: 2018-02-07
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-randomised intervenion
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria: Elective laparoscopic general surgery -

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

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Primary outcomes:
measure: Non-relevant conversation
timeFrame: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Secondary outcomes:
measure: Postoperative complication
timeFrame: 30 days after surgery
measure: Intraoperative unplanned event
timeFrame: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
measure: Corrections of assistant surgeon
timeFrame: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
measure: Operation time
timeFrame: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Other outcomes:
Locations:
city: Lindesberg
country: Sweden
facility: Lindesbergs Hospital
Study officials:
affiliation: Örebro University, Region Örebro Län
name: Erik Stenberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bergstrom H, Larsson LG, Stenberg E. Audio-video recording during laparoscopic surgery reduces irrelevant conversation between surgeons: a cohort study. BMC Surg. 2018 Nov 6;18(1):92. doi: 10.1186/s12893-018-0428-x.