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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

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.

Condition or disease Intervention/treatment Phase
Perioperative/Postoperative Complications Laparoscopy Communication Communication, Multidisciplinary Other: Audio-recoring Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
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
Official Title: Audio Recording During Laparoscopic Surgery - The Impact on Conversation Between Surgeons
Actual Study Start Date : August 29, 2017
Actual Primary Completion Date : September 28, 2017
Actual Study Completion Date : September 28, 2017

Arm Intervention/treatment
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.
Other: Audio-recoring
Recording of audio through microphone carried bu surgeon and assistant surgeon




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Postoperative complication [ Time Frame: 30 days after surgery ]
    complication occuring within the first 30 Days after surgery

  2. 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

  3. 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

  4. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Elective laparoscopic general surgery -

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

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03425175


Locations
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Sweden
Lindesbergs Hospital
Lindesberg, Sweden, 71182
Sponsors and Collaborators
Region Örebro County
Örebro University, Sweden
Investigators
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Principal Investigator: Erik Stenberg, MD, PhD Örebro University, Region Örebro Län
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Erik Stenberg, MD, PhD, Principal Investigator, Region Örebro County
ClinicalTrials.gov Identifier: NCT03425175    
Other Study ID Numbers: EPN 2017/247
First Posted: February 7, 2018    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All results

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erik Stenberg, MD, PhD, Region Örebro County:
Non-relevant conversation
Surgical safety
Audio recording
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes