Audio Recording During Laparoscopic Surgery

NCT ID: NCT03425175

Last Updated: 2018-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-29

Study Completion Date

2017-09-28

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).

Conditions

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Perioperative/Postoperative Complications Laparoscopy Communication Communication, Multidisciplinary

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Non-randomised intervenion
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Open label

Study Groups

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Control group

Standard care with recording of video but no audio-recording

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

Standard care with the addition of simultaneous audio-recording during the operation.

Group Type EXPERIMENTAL

Audio-recoring

Intervention Type OTHER

Recording of audio through microphone carried bu surgeon and assistant surgeon

Interventions

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Audio-recoring

Recording of audio through microphone carried bu surgeon and assistant surgeon

Intervention Type OTHER

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro University, Sweden

OTHER

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Erik Stenberg, MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik Stenberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Region Örebro Län

Locations

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Lindesbergs Hospital

Lindesberg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 30400860 (View on PubMed)

Other Identifiers

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EPN 2017/247

Identifier Type: -

Identifier Source: org_study_id

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