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Modeling Technical Error and Adverse Outcomes

A Model of the Relationship Between Technical Error and Adverse Patient Outcome: A Constructive Grounded Theory Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04183439
Enrollment
11
Registered
2019-12-03
Start date
2016-12-30
Completion date
2019-01-07
Last updated
2019-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Errors

Brief summary

The investigators' objective was to develop a theoretical model exploring the relationship between technical errors and adverse patient outcomes. To achieve this aim, the investigators interviewed surgeons from a diverse group of surgical specialties, asking them about their adverse outcomes from surgery and their most granular surgical techniques. the investigators' focus was on adverse outcomes that could be predictably associated with imperfect surgical technique and therefore prevented with proper technique.

Detailed description

Background: Minute technical errors performed by the surgeon have the potential to lead to adverse patient outcomes. The objective was to gain a deeper understanding of this relationship through the development of an intraoperative model. Materials and Methods: The investigators used Constructivist Grounded Theory methodology, including a comprehensive review of the literature and interviews with surgeons, focusing on avoidance of technical errors. The investigators used the Observational Clinical Human Reliability Assessment system, which categorizes granular, technical intraoperative errors, as their conceptual framework. The investigators iteratively interviewed surgeons, from multiple adult and pediatric surgical specialties, refined our semi-structured interview, and developed a model. The model remained stable after interviewing 11 surgeons, and it was reviewed it with earlier interviewed surgeons.

Interventions

None listed

Sponsors

University of Missouri, Kansas City
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Surgical teacher

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Model of the relationship between minute, technical motions by a surgeon and intraoperative adverse events, and eventually adverse patient outcomesapproximately 2 yearsThis is a qualitative study interviewing surgeons about the link between technical motions and adverse patient outcomes. Our primary outcome will be a model, developed from their answers.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026