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NCT04994392 · ClinicalTrials.gov registry record
Intra-Operative Complication Assessment and Reporting With Universal Standards: Survey
A clinical trial, sponsored by University of Southern California.
- Completed
- Registry status
- 4,821
- Enrollment target
NCT04994392: Completed study, sponsored by University of Southern California.
NCT04994392 is a clinical trial that has completed, run by University of Southern California. The registered enrollment target is 4,821 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04994392 has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- 4,821 participants
- Enrollment target
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 un
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,821 participants |
| Start Date | 2021-07-10 |
| Est. Completion | 2022-04-30 |
What the finished NCT04994392 record still lists
NCT04994392 is an observational study that tracks outcomes without assigning an intervention. Its 4,821 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT04994392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04994392 about?
NCT04994392 is a clinical study titled "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...
What is the current status of trial NCT04994392?
This trial is currently completed. The enrollment target is 4,821 participants. The study started on 2021-07-10. Estimated completion is 2022-04-30.
Who is sponsoring clinical trial NCT04994392?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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