Audio Recording During Laparoscopic Surgery

NCT03425175 | Completed

• 1 other identifier: EPN 2017/247
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Non-relevant conversation; Surgical safety; Audio recording

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Postoperative complication

  30 days after surgery

• Intraoperative unplanned event

  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

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

• Operation time

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

Study Arms (2)

Control group

NO INTERVENTION

Standard care with recording of video but no audio-recording

Intervention group

EXPERIMENTAL

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

Other: Audio-recoring

Interventions

Audio-recoring OTHER

Recording of audio through microphone carried bu surgeon and assistant surgeon

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Region Örebro County: lead
• Örebro University, Sweden: collaborator

Study Sites (1)

Lindesbergs Hospital

Lindesberg, 71182, Sweden

Location

Related Publications (1)

• 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.

  PMID: 30400860 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Communication

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Erik Stenberg, MD, PhD

  Örebro University, Region Örebro Län

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Non-randomised intervenion

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: February 7, 2018
• Study Start: August 29, 2017
• Primary Completion: September 28, 2017
• Study Completion: September 28, 2017
• Last Updated: February 7, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)