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NCT Number: NCT04994392

Intra-Operative Complication Assessment and Reporting With Universal Standards: Survey

Perioperative complications, especially intraoperative adverse events (iAEs), carry significant potential for long-term sequelae in a patient's postoperative course. Without consistent and homogenous reporting, these events represent a substantial gap in contemporary surgical literature and clinical practice. By definition, an iAE is any unplanned incident related to a surgical intervention occurring between skin incision and skin closure.

Despite the availability of multiple intraoperative classification systems, the reporting of intraoperative adverse events remains exceedingly rare. Further, while most studies report postoperative adverse events, only a fraction of surgical publications report intraoperative complications as outcomes of interest. Many reasons could be related to this dearth in iAE reporting, ranging from a lack of clear iAE definitions to a fear of litigation. Broadly speaking, iAEs are negative outcomes, which, on the whole, epitomize a paradoxically well-documented bias in the literature.

The investigators performed an umbrella review and meta-analysis of prior systematic reviews of complication reporting in a number of key urologic surgical domains. The investigators have since worked with academic surgeons to produce a set of iAE reporting guidelines known as the Intraoperative Complication Assessment and Reporting with Universal Standards (ICARUS) Guidelines. These reporting criteria were developed using the reporting guidelines using the framework outlined by the EQUATOR Network (Enhancing the QUAlity and Transparency Of health Research; www.equator-network.org/).

As part of a prospective effort to evaluate the utility of these new guidelines, the investigators are performing a study of surgeons, anesthesiologists,s and nurses perceptions regarding iAE reporting and the global applicability of the new iAE reporting guidelines.

In part one of this study, a series of survey questions will be used to better elucidate surgeon perceptions underlying the contemporary deficit in iAE reporting. In part two of this study, a set of assessments to representatives within various surgical specialties to assess the global applicability of the newly developed iAE reporting guidelines.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Southern California

Los Angeles, California, 90005, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documented understanding, willingness, and agreement to participate in this study
  • Males and females; age 18 or older
  • Must be either English speaking or fluent with English medical terminology
  • Currently or formerly practicing surgeon or proceduralist, regardless of the domain

Exclusion criteria

  • Activity restrictions that limit one's ability to engage in online survey
  • Adults not competent to consent
  • Minors, human fetuses, neonates
  • Prisoners/Detainees

The sample size of the survey is calculated as reported by Taherdoost, Hamed et al. Determining Sample Size; How to Calculate Survey Sample Size (2017). International Journal of Economics and Management Systems, Vol. 2, 2017, considering the worldwide surgeons and anesthesiologists population (n. 1,853,842) accordingly to the most recent WHO Surgical workforce Census (https://apps.who.int/gho/data/view.main.HRSWF),with a 95% Level and 2% marginal error.

Treatment and study plan

Primary outcomes

  1. Global perception of intraoperative adverse event reporting

    Time frame: July 30th 2021 till September 30th 2021

    A series of 5-point Likert scale assessments relating to surgeon perception of intraoperative adverse assessment as it related to the following domains: reporting habits, practical considerations, clinical and quality improvement utility, emotional response, and perceived consequences. The questions do not include any validated questionnaires or psychometric evaluations. Descriptive statistical assessment of responses.

  2. Global applicability of the ICARUS reporting criteria

    Time frame: July 30th 2021 till September 30th 2021

    Determination of global applicability (clinical utility and quality improvement utility) of the ICARUS reporting criteria as determined by subjective 5-point Likert scale assessments. Outcomes to be assessed by percent agreement and interrater consistency.

Secondary outcomes

  1. Specialty specific perception of intraoperative adverse event reporting

    Time frame: July 30th 2021 till September 30th 2021

    A series of 5-point Likert scale assessments relating to surgeon perception of intraoperative adverse assessment as it related to the following domains: reporting habits, practical considerations, clinical and quality improvement utility, emotional response, and perceived consequences. The questions do not include any validated questionnaires or psychometric evaluations. Descriptive statistical assessment of responses.

  2. Specialty-specific applicability of ICARUS guidelines

    Time frame: July 30th 2021 till September 30th 2021

    Determination of specialty specific applicability (clinical utility and quality improvement utility) of the ICARUS reporting criteria as determined by subjective 5-point Likert scale assessments. Outcomes to be assessed by percent agreement and interrater consistency.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Intra-Operative Complication Assessment and Reporting With Universal Standards: Surgeons, Anesthesiologists, and Nurses Survey

Acronym: ICARUS-S

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 6, 2021
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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