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Effectiveness, neuropsychological distress, teamwork, and ergonomics with procedures conducted in the i-Suite surgical environment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN94152783
Enrollment
400
Registered
2008-04-11
Start date
2008-05-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

All elective orthopedic and/or trauma, or visceral surgical procedures. Surgery N/A

Interventions

Experimental intervention: General orthopedic (e.g., total joint replacement), trauma, and surgical procedures (e.g., fracture fixation, abdominal and thoracic surgery) conducted in one of two integ

Sponsors

Unfallkrankenhaus Berlin Trauma Center (Germany)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consecutive patients >=18 years of age scheduled for orthopedic and/or trauma, or visceral surgery on weekdays between 8.00 am and 4.00 pm (core working hours) 2. Full ability to provide written informed consent 3. Both men and women

Exclusion criteria

Exclusion criteria: 1. Acute, emergency, or life-saving surgery 2. Refusal of trial participation

Design outcomes

Primary

MeasureTime frame
Time interval from the patient's entry to discharge from the operating theatre.

Secondary

MeasureTime frame
1. Team-centered endpoints, recorded during operation: 1.1. Stress of surgeons, anaesthetists, and scrub nurses in charge, as measured by short questionnaire assessments and biological markers in saliva (cortisol and beta-endorphine) immediately before and after surgery 1.2. Quantity and quality of distracting events (e.g., phone calls, door openings, technical failures) that may prolong or compromise the procedure 1.3. Comfort and climate (e.g., space, noise, and others) 1.4. Perceived success of the procedure 1.5. Team interaction 2. Patient-centered endpoints: 2.1. Critical incidents, intra- and post-operative complications, monitored during hospital stay until discharge 2.2. Quality of Life (EuroQol [EQ5D]) questionnaire at baseline, discharge and 6 months after surgery (by post)

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026