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

NCT04994392 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 4821

Last updated 2022-05-19

No results posted yet for this study

Summary

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.

Conditions

  • Intraoperative Complications
  • Surgery--Complications
  • Surgery
  • Surgical Procedure, Unspecified

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • Giovanni E Cacciamani, MD · University of Southern California

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-10
Primary Completion
2022-03-01
Completion
2022-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04994392 on ClinicalTrials.gov