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Completed

NCT Number: NCT03425175

Audio Recording During Laparoscopic Surgery

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.

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Key information

Conditions

Perioperative/Postoperative Complications Behavior Communication Communication, Multidisciplinary Laparoscopy Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lindesbergs Hospital

Lindesberg, 71182, Sweden

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Elective laparoscopic general surgery -

Exclusion criteria

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

-

Treatment and study plan

Audio-recoring

Other

Recording of audio through microphone carried bu surgeon and assistant surgeon

Primary outcomes

  1. Non-relevant conversation

    Time frame: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)

    Time spent on non-relevant conversation

Secondary outcomes

  1. Postoperative complication

    Time frame: 30 days after surgery

    complication occuring within the first 30 Days after surgery

  2. Intraoperative unplanned event

    Time frame: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)

    Any deviation from expected events during the surgical procedure

  3. Corrections of assistant surgeon

    Time frame: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)

    number of corrections of assistant surgeon made by the operating surgeon

  4. Operation time

    Time frame: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)

    Length of operation

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • Örebro University, Sweden

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 7, 2018
Registry last updated
Feb 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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