Back to resultsAudio Recording During Laparoscopic Surgery
Primary Purpose
Perioperative/Postoperative Complications, Laparoscopy, Communication
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Audio-recoring
Sponsored by
About this trial
This is an interventional health services research trial for Perioperative/Postoperative Complications focused on measuring Non-relevant conversation, Surgical safety, Audio recording
Eligibility Criteria
Inclusion Criteria: Elective laparoscopic general surgery -
Exclusion Criteria:R, planned open surgery, refusal to participate (patient or operating team)
-
Sites / Locations
- Lindesbergs Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention group
Arm Description
Standard care with recording of video but no audio-recording
Standard care with the addition of simultaneous audio-recording during the operation.
Outcomes
Primary Outcome Measures
Non-relevant conversation
Time spent on non-relevant conversation
Secondary Outcome Measures
Postoperative complication
complication occuring within the first 30 Days after surgery
Intraoperative unplanned event
Any deviation from expected events during the surgical procedure
Corrections of assistant surgeon
number of corrections of assistant surgeon made by the operating surgeon
Operation time
Length of operation
Full Information
NCT ID
NCT03425175
First Posted
January 24, 2018
Last Updated
January 31, 2018
Sponsor
Region Örebro County
Collaborators
Örebro University, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT03425175
Brief Title
Audio Recording During Laparoscopic Surgery
Official Title
Audio Recording During Laparoscopic Surgery - The Impact on Conversation Between Surgeons
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 29, 2017 (Actual)
Primary Completion Date
September 28, 2017 (Actual)
Study Completion Date
September 28, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Örebro County
Collaborators
Örebro University, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative/Postoperative Complications, Laparoscopy, Communication, Communication, Multidisciplinary
Keywords
Non-relevant conversation, Surgical safety, Audio recording
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Non-randomised intervenion
Masking
None (Open Label)
Masking Description
Open label
Allocation
Non-Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Standard care with recording of video but no audio-recording
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Standard care with the addition of simultaneous audio-recording during the operation.
Intervention Type
Other
Intervention Name(s)
Audio-recoring
Intervention Description
Recording of audio through microphone carried bu surgeon and assistant surgeon
Primary Outcome Measure Information:
Title
Non-relevant conversation
Description
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 Outcome Measure Information:
Title
Postoperative complication
Description
complication occuring within the first 30 Days after surgery
Time Frame
30 days after surgery
Title
Intraoperative unplanned event
Description
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)
Title
Corrections of assistant surgeon
Description
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)
Title
Operation time
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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)
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Stenberg, MD, PhD
Organizational Affiliation
Örebro University, Region Örebro Län
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lindesbergs Hospital
City
Lindesberg
ZIP/Postal Code
71182
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All results
Citations:
PubMed Identifier
30400860
Citation
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.
Results Reference
derived
Learn more about this trial
Audio Recording During Laparoscopic Surgery
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