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Operating-Room Distractions, Surgeon Workload, Anxiety, Teamwork and Intraoperative Adverse Events (ORCHESTRA)

Operating-Room Distractions, Surgeon Workload, Anxiety, Teamwork and Intraoperative Adverse Events (ORCHESTRA)

Recruiting
18 years and older
All
Phase N/A

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Overview

During surgery, telephone calls, conversations, equipment problems and other events may distract the operating team. Some events interrupt the progress of the operation. The surgeon's workload and anxiety, together with how well the team works together, may also be related to events that occur during surgery.

ORCHESTRA is an observational study of patients undergoing colorectal or anal surgery in a single hospital. Trained observers record distractions during routine operations. After each operation, the surgeon reports workload and anxiety, and an observer assesses teamwork. Intraoperative adverse events are graded using a standard severity classification. The study examines how these measurements are related. It does not assign treatments, introduce distractions or change routine surgical care.

Description

ORCHESTRA is a prospective, single-centre observational cohort study conducted in an academic colorectal surgery unit. Consecutive eligible patients undergoing colorectal or anal procedures performed by one designated surgeon are observed during routine surgical care. The operating surgeon and participating theatre staff gave consent to observation and questionnaire assessment at the start of the study.

Two independent observers record naturally occurring distractions in real time, including their type, operative phase and observable impact. Distractions are classified as A, potentially distracting; B, visibly distracting the team; or C, interrupting operative flow. The principal exposure is the number of C-class events per operation. Additional summaries include category-specific counts, total distraction count and a weighted score calculated as A + 2B + 3C.

Intraoperative adverse events are assessed using ClassIntra, with the maximum grade per operation serving as the primary outcome. Immediately after surgery, the operating surgeon completes the study's SURG-TLX implementation and STAI-State. Team collaboration is assessed by the observers using the study's OTAS implementation. Recorded patient and procedure characteristics include age, ASA physical status, obesity, procedure category and operative duration.

Ordinal regression examines associations with increasing ClassIntra severity. Related models consider workload and anxiety together and separately because these measures may be strongly correlated. Additional analyses describe distraction patterns, teamwork, workload and anxiety, and assess more clinically consequential events using a ClassIntra grade II or higher threshold. The study is observational and does not establish causal effects.

Eligibility

Inclusion Criteria:

  • Age 18 years or older.
  • Undergoing a colorectal or anal operation in the participating unit, performed by the designated surgeon, during recruitment.
  • Written informed consent.

Exclusion Criteria:

\- None.

Study details
    Intraoperative Complications
    Colorectal Diseases
    Anal Diseases

NCT07874412

National and Kapodistrian University of Athens

21 October 2026

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