Audio Recording During Laparoscopic Surgery

Study Overview
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Brief Summary
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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
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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).

Official Title
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Audio Recording During Laparoscopic Surgery - The Impact on Conversation Between Surgeons

Conditions
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Perioperative/Postoperative Complications, Laparoscopy, Communication, Communication, Multidisciplinary

Intervention / Treatment
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* Other: Audio-recoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Elective laparoscopic general surgery - Exclusion Criteria:R, planned open surgery, refusal to participate (patient or operating team) -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-randomised intervenion
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Standard care with recording of video but no audio-recording | |
| Experimental: Intervention group<br>Standard care with the addition of simultaneous audio-recording during the operation. | Other: Audio-recoring<br>* Recording of audio through microphone carried bu surgeon and assistant surgeon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complication | complication occuring within the first 30 Days after surgery | 30 days after surgery | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgical safety, Non-relevant conversation, Audio recording