Audio Recording During Laparoscopic Surgery

Not Applicable

Completed

• Conditions: Communication, Multidisciplinary; Laparoscopy; Perioperative/Postoperative Complications; Communication
• Interventions: Other: Audio-recoring

• Registration Number: NCT03425175
• Lead Sponsor: Region Örebro County

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.

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 Timeline

• Study Start: 2017-08-29
• Primary Completion: 2017-09-28
• Study Completion: 2017-09-28
• Status Verified: 2018-01
• Study First Submitted: 2018-01-24
• Study First Submitted QC: 2018-01-31
• Last Update Submitted: 2018-01-31
• Study First Posted: 2018-02-07
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Elective laparoscopic general surgery -

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Audio-recoring	Standard care with the addition of simultaneous audio-recording during the operation.

Primary Outcome Measures

Name	Time	Method
Non-relevant conversation	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 Outcome Measures

Name	Time	Method
Operation time	Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)	Length of operation
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)	number of corrections of assistant surgeon made by the operating surgeon
Postoperative complication	30 days after surgery	complication occuring within the first 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)	Any deviation from expected events during the surgical procedure

Trial Locations

Locations (1)

Lindesbergs Hospital; 🇸🇪 Lindesberg, Sweden