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NCT07874412
Operating-Room Distractions, Surgeon Workload, Anxiety, Teamwork and Intraoperative Adverse Events (ORCHESTRA)
Conditions: Intraoperative Complications, Colorectal Diseases, Anal Diseases
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 400
Sponsor: National and Kapodistrian University of Athens
Location: Ippokrateio Hospital Athens
Summary
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07874412). StuddyBuddy aggregates publicly available trial information.