Intra-Operative Complication Assessment and Reporting With Universal Standards: Survey (ICARUS-S)

University of Southern California

Status: Completed

Conditions: Intraoperative Complications; Surgical Procedure, Unspecified; Surgery; Surgery--Complications

Study type: Observational

Funder types: Other

Identifiers

NCT04994392

UP-21-00473

Details and patient eligibility

About

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.

Enrollment: 4,821 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Activity restrictions that limit one's ability to engage in online survey

2. Adults not competent to consent

3. Minors, human fetuses, neonates

4. 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.