Perioperative/Postoperative ComplicationsNCT03425175
Audio Recording During Laparoscopic Surgery
A study testing Audio-recoring in people with Perioperative/Postoperative Complications and Laparoscopy, run by Region Örebro County at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perioperative/Postoperative Complications, Laparoscopy, Communication
- What is being tested?
- Audio-recoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSweden
- Study dates
- 29 Aug 2017to 28 Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Exclusion Criteria:R, planned open surgery, refusal to participate (patient or operating team)
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Audio Recording During Laparoscopic Surgery - The Impact on Conversation Between Surgeons
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.
Read the 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).
- Conditions
- Perioperative/Postoperative Complications, Laparoscopy, Communication, Communication, Multidisciplinary
- Being tested
- Audio-recoring
- Keywords
- Non-relevant conversation, Surgical safety, Audio recording
- Medical subject headings
- Postoperative Complications, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio-recoringOther
Recording of audio through microphone carried bu surgeon and assistant surgeon
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Standard care with recording of video but no audio-recording |
| Intervention group | Experimental | Standard care with the addition of simultaneous audio-recording during the operation. Receives: Other: Audio-recoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-relevant conversation
Time spent on non-relevant conversation
Measured: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Secondary outcomes (4)
Postoperative complication
complication occuring within the first 30 Days after surgery
Measured: 30 days after surgery
Intraoperative unplanned event
Any deviation from expected events during the surgical procedure
Measured: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Corrections of assistant surgeon
number of corrections of assistant surgeon made by the operating surgeon
Measured: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Operation time
Length of operation
Measured: Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2018
- Study start29 Aug 2017
- Primary completion28 Sep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perioperative/Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomised intervenion
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden
- Responsible party
- Principal investigator, Erik Stenberg, MD, PhD, Region Örebro County
- Investigators
- Erik Stenberg, MD, PhD, Principal investigator, Örebro University, Region Örebro Län
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03425175
- Sponsor's protocol ID
- EPN 2017/247
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2018
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All results
Publications
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.
PubMed 30400860
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audio Recording During Laparoscopic Surgery - The Impact on Conversation Between Surgeons
- ClinicalTrials.gov ID
- NCT03425175
- Acronym / sponsor ID
- EPN 2017/247
- Conditions
- Perioperative/Postoperative Complications, Laparoscopy, Communication, Communication, Multidisciplinary
- Keywords
- Non-relevant conversation, Surgical safety, Audio recording
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Örebro University, Sweden
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 7 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomised intervenion
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Standard care with recording of video but no audio-recording |
| Intervention group | Experimental | Other: Audio-recoringStandard care with the addition of simultaneous audio-recording during the operation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Exclusion Criteria:R, planned open surgery, refusal to participate (patient or operating team)
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio-recoringRecording of audio through microphone carried bu surgeon and assistant surgeon | Other | Intervention group |
Primary outcome
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
4 secondary outcomes
Postoperative complication
Time frame: 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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
- Derived from this study: PubMed 30400860Bergstrom 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.
- Individual participant dataSharing planned: No. All results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Stenberg, MD, PhD principal investigator
Örebro University, Region Örebro Län
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio-recoring in people with Perioperative/Postoperative Complications and Laparoscopy, run by Region Örebro County at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03425175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.