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Audio Recording During Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT03425175
Recruitment Status : Completed
First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Collaborator:
Örebro University, Sweden
Information provided by (Responsible Party):
Erik Stenberg, MD, PhD, Region Örebro County

Tracking Information
First Submitted Date  ICMJE January 24, 2018
First Posted Date  ICMJE February 7, 2018
Last Update Posted Date February 7, 2018
Actual Study Start Date  ICMJE August 29, 2017
Actual Primary Completion Date September 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
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) ]
Time spent on non-relevant conversation
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2018)
  • Postoperative complication [ Time Frame: 30 days after surgery ]
    complication occuring within the first 30 Days after surgery
  • Intraoperative unplanned event [ Time Frame: 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
  • Corrections of assistant surgeon [ Time Frame: 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
  • Operation time [ Time Frame: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place) ]
    Length of operation
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Audio Recording During Laparoscopic Surgery
Official Title  ICMJE Audio Recording During Laparoscopic Surgery - The Impact on Conversation Between Surgeons
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Non-randomised intervenion
Masking: None (Open Label)
Masking Description:
Open label
Primary Purpose: Health Services Research
Condition  ICMJE
  • Perioperative/Postoperative Complications
  • Laparoscopy
  • Communication
  • Communication, Multidisciplinary
Intervention  ICMJE Other: Audio-recoring
Recording of audio through microphone carried bu surgeon and assistant surgeon
Study Arms  ICMJE
  • No Intervention: Control group
    Standard care with recording of video but no audio-recording
  • Experimental: Intervention group
    Standard care with the addition of simultaneous audio-recording during the operation.
    Intervention: Other: Audio-recoring
Publications * Bergström 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2018)
41
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 28, 2017
Actual Primary Completion Date September 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: Elective laparoscopic general surgery -

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

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03425175
Other Study ID Numbers  ICMJE EPN 2017/247
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: All results
Responsible Party Erik Stenberg, MD, PhD, Region Örebro County
Study Sponsor  ICMJE Region Örebro County
Collaborators  ICMJE Örebro University, Sweden
Investigators  ICMJE
Principal Investigator: Erik Stenberg, MD, PhD Örebro University, Region Örebro Län
PRS Account Region Örebro County
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP