ClinicalTrials.gg
CompletedNCT03425175Updated Feb 7, 2018

Audio Recording During Laparoscopic Surgery

An interventional study of Audio-recoring in Perioperative/Postoperative Complications, Laparoscopy and Communication, sponsored by Region Örebro County. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-07.

Sponsored by Region Örebro County · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Aug 2017, registered Jan 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

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

Keywords

  • Non-relevant conversation
  • Surgical safety
  • Audio recording
03

In context

Postoperative Complications

1,332 studies on the registry are indexed under Postoperative Complications; 311 are open to participants now.

This study's enrollment of 41 is below the median of 114 across 766 interventional studies indexed under Postoperative Complications.

Browse Postoperative Complications studies →

Lead sponsor

Region Örebro County is the lead sponsor of 124 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: Elective laparoscopic general surgery -

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

-

05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
41 participants (actual)

Study arms

  • 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

Interventions

  • OtherAudio-recoring

    Recording of audio through microphone carried bu surgeon and assistant surgeon

06

What researchers measure

Primary outcomes

  1. Non-relevant conversation

    Time spent on 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)

Secondary outcomes

  1. Postoperative complication

    complication occuring within the first 30 Days after surgery

    Time frame: 30 days after surgery

  2. Intraoperative unplanned event

    Any deviation from expected events during the surgical procedure

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

  3. Corrections of assistant surgeon

    number of corrections of assistant surgeon made by the operating surgeon

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

  4. Operation time

    Length of operation

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

07

Study locations

1 site
  • Lindesbergs Hospital
    Lindesberg, 71182, Sweden
08

References and documents

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. PubMed 30400860 ↗

Individual participant data

Plan to share: No — All results

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 7, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03425175
Collaborators
Örebro University, Sweden
Responsible party
Erik Stenberg, MD, PhD (Principal Investigator, Region Örebro County) — Principal investigator
First posted
Feb 7, 2018
Start date
Aug 29, 2017
Primary completion
Sep 28, 2017
Completion
Sep 28, 2017
Last update
Feb 7, 2018

Study contacts

Erik Stenberg, MD, PhD
principal investigator · Örebro University, Region Örebro Län

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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