Modeling Technical Error and Adverse Outcomes

NCT ID: NCT04183439

Last Updated: 2019-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-30

Study Completion Date

2019-01-07

Brief Summary

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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

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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.

Conditions

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Surgical Errors

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Surgeons Interviewed

We recruited surgeons from two University academic health centers, one specializing in adults and the other in children. The surgeons were selected through a snowball technique and emailed to participate. DK and GS interviewed eleven surgical attendings representing 10 surgical specialties. (Table 2) Each subject had at least 10 years of experience in their respective fields and regularly taught residents.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Surgical teacher

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Missouri, Kansas City

OTHER

Sponsor Role lead

Responsible Party

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Gary Sutkin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gary Sutkin

Role: PRINCIPAL_INVESTIGATOR

University Missouri Kansas City

References

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Tang B, Hanna GB, Joice P, Cuschieri A. Identification and categorization of technical errors by Observational Clinical Human Reliability Assessment (OCHRA) during laparoscopic cholecystectomy. Arch Surg. 2004 Nov;139(11):1215-20. doi: 10.1001/archsurg.139.11.1215.

Reference Type RESULT
PMID: 15545569 (View on PubMed)

Other Identifiers

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17-076

Identifier Type: -

Identifier Source: org_study_id

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