CLASSIC

• Research type

  Research Study

• Full title

  Classification of Intraoperative Complications

• IRAS ID

  235958

• Contact name

  Sonja Meier

• Contact email

  sonja.meier@gstt.nhs.uk

• Sponsor organisation

  University Hospital Basel

• Duration of Study in the UK

  0 years, 3 months, 31 days

• Research summary

  Currently there is little evidence regarding the reporting of complications in surgery. These are required to improve patient safety. There was an initiative launched in 2010 - Core Outcome Measure in Effectiveness Trials (COMET) to define standard outcomes measures. This was to be achieved by comparing data from clinical trials, systematic reviews (summarises the results of available carefully designed healthcare studies (controlled trials) and provides a high level of evidence on the effectiveness of healthcare interventions) and meta-analysis (a statistical way of combining the results of several similar studies).
  For clinical trials for patients undergoing a surgical procedure outcomes should be considered after surgery and also during surgery. There are several validated systems for reporting postoperative complications, there are only a few and these are not prospectively validated systems (evaluated on the basis of past experience to determine whether they might lead to critical situations) for reporting complications during the surgery itself.
  Within a Delphi study (this is a known method of structured communication technique which relies on a panel of experts answering questionnaire) involving international interdisciplinary experts, a definition and classification for complications during surgery (intraoperative) has been developed. The classification system uses a clearly defined classifications based on the therapy used to treat the intraoperative complication. As both surgery and anaesthesia may be involved in complications in the surgical process period, all patient-related intraoperative complications between skin incision and closure are considered in this reporting system regardless whether they are surgery- or anaesthesia-related deviations from the ideal surgery process.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  18/LO/0210

• Date of REC Opinion

  5 Feb 2018

• REC opinion

  Favourable Opinion