Audio Recording During Laparoscopic Surgery

• Sponsor: Region Örebro County (Other)
• Overall Status: Completed
• CT.gov ID: NCT03425175
• Collaborator: Örebro University, Sweden (Other)
• Enrollment: 41
• Location: 1
• Arms: 2
• Actual Duration (Days): 30
• Patients Per Site Per Month: 41.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Perioperative/Postoperative Complications; Laparoscopy; Communication; Communication, Multidisciplinary	Other: Audio-recoring	N/A

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

• Study Type: Interventional
• Actual Enrollment: 41 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Non-randomised intervenionNon-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: Aug 29, 2017
• Actual Primary Completion Date: Sep 28, 2017
• Actual Study Completion Date: Sep 28, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Non-relevant conversation [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 [30 days after surgery]

   complication occuring within the first 30 Days after surgery

2. Intraoperative unplanned event [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 [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 [Operation. Measured from from the start of the operation (WHO surgical safety checklist) until end of operation (last stitch in place)]

   Length of operation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria: Elective laparoscopic general surgery -

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

-

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lindesbergs Hospital	Lindesberg		Sweden	71182

Sponsors and Collaborators

• Region Örebro County
• Örebro University, Sweden

Investigators

• Principal Investigator: Erik Stenberg, MD, PhD, Örebro University, Region Örebro Län

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erik Stenberg, MD, PhD, Principal Investigator, Region Örebro County
• ClinicalTrials.gov Identifier: NCT03425175
• Other Study ID Numbers: EPN 2017/247
• First Posted: Feb 7, 2018
• Last Update Posted: Feb 7, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Principal Investigator, Region Örebro County: Non-relevant conversation; Surgical safety; Audio recording
• Additional relevant MeSH terms: Postoperative Complications

Study Results

No Results Posted as of Feb 7, 2018