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Simultaneous Video and Audio Recording of Gallbladder Removal Using Minimally Invasive Surgery


- candidate number28506
- NTR NumberNTR7008
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-jan-2018
- Secondary IDsMEC-2018-1154 
- Public TitleSimultaneous Video and Audio Recording of Gallbladder Removal Using Minimally Invasive Surgery
- Scientific TitleSimultaneous Video and Audio Recording of Laparoscopic Cholecystectomy Procedures
- ACRONYMSONAR-Trial
- hypothesisIntraoperative video recording combined with synchronous audio recording of the operator's voice during laparoscopic cholecystectomy will more adequately document the essential steps of the surgical procedure compared to the narrative operative report alone.
- Healt Condition(s) or Problem(s) studiedCholecystitis, Laparoscopy, Cholelithiasis
- Inclusion criteria- Patients aged 18 years or older
- Elective laparoscopic cholecystectomy procedure
- Exclusion criteria- Study cases with incomplete video recordings
- Study cases with incomplete audio recordings
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-mrt-2018
- planned closingdate1-mrt-2019
- Target number of participants73
- Interventions- Intraoperative video recording of the surgical procedure using the available endoscopy equipment
- Simultaneous intraoperative audio recording of the operator's voice using a wearable microphone
- Primary outcomeThe availability of information regarding the essential steps of laparoscopic cholecystectomy
- Secondary outcomeQuality of surgery
- TimepointsDuring the procedure: from initial introduction, until disconnection of the endoscope at the end of the procedure
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Özgür Eryigit
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.F. Lange
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publicationsvan de Graaf FW, Lange MM, Menon AG, O'Mahoney PR, Milsom JW, Lange JF. Imaging for Quality Control: Comparison of Systematic Video Recording to the Operative Note in Colorectal Cancer Surgery. A Pilot Study. Ann Surg Oncol. 2016 Dec;23(Suppl 5):798-803. Epub 2016 Sep 22. Erratum in: Ann Surg Oncol. 2016 Dec;23 (Suppl 5):1065. PubMed PMID: 27660256;
PubMed Central PMCID: PMC5149562.

Wauben LS, van Grevenstein WM, Goossens RH, van der Meulen FH, Lange JF.
Operative notes do not reflect reality in laparoscopic cholecystectomy. Br J Surg. 2011 Oct;98(10):1431-6. doi: 10.1002/bjs.7576. Epub 2011 Jun 1. PubMed PMID: 21633952.
- Brief summaryPrevious research has demonstrated that intraoperative video recording during surgery will provide an objective and more complete documentation of the surgical procedure.
In this study, we will evaluate the added value of video recording with synchronous audio recording of the operator's voice compared to the traditional narrative operative report in patients undergoing elective laparoscopic cholecystectomy.
- Main changes (audit trail)
- RECORD29-jan-2018 - 9-apr-2018


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