Audio Recording During Laparoscopic Surgery

Communication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03425175
• Other study ID #: EPN 2017/247
• Status: Completed
• Phase: N/A
• First received: January 24, 2018
• Last updated: January 31, 2018
• Start date: August 29, 2017
• Est. completion date: September 28, 2017

Study information

• Verified date: January 2018
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 28, 2017
• Est. primary completion date: September 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria: Elective laparoscopic general surgery -

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Audio-recoring
Recording of audio through microphone carried bu surgeon and assistant surgeon

Locations

Country	Name	City	State
Sweden	Lindesbergs Hospital	Lindesberg

Sponsors (2)

Lead Sponsor	Collaborator
Region Örebro County	Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative complication	complication occuring within the first 30 Days after surgery	30 days after surgery
Secondary	Intraoperative unplanned event	Any deviation from expected events during the surgical procedure	Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Secondary	Corrections of assistant surgeon	number of corrections of assistant surgeon made by the operating surgeon	Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Secondary	Operation time	Length of operation	Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)