Audio Recording During Laparoscopic Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Communication; Laparoscopy; Perioperative/Postoperative Complications; Communication, Multidisciplinary
• Intervention / Treatment: Other: Audio-recoring

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).

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lindesberg, Sweden, 71182
    • Lindesbergs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: Elective laparoscopic general surgery -

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

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Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Region Örebro County
• Collaborators: Örebro University, Sweden
• Investigators: Principal Investigator: Erik Stenberg, MD, PhD, Örebro University, Region Örebro Län

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2017
• Primary Completion (Actual): September 28, 2017
• Study Completion (Actual): September 28, 2017

Study Registration Dates

• First Submitted: January 24, 2018
• First Submitted That Met QC Criteria: January 31, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: January 31, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Audio recording; Non-relevant conversation; Surgical safety
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: EPN 2017/247

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No