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ISRCTN
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ISRCTN94152783
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ClinicalTrials.gov identifier
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Public title
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Effectiveness, neuropsychological distress, teamwork, and ergonomics with procedures conducted in the i-Suite surgical environment
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Scientific title
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Acronym
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ENTERPRISE
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Serial number at source
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ukb_6.1_2008
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Study hypothesis
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A novel, integrated operating theatre environment (i-Suite™, Stryker) reduces the average or time in trauma, orthopaedic, and visceral procedures (i.e., the time interval from the patient's entry to discharge from the theatre) compared to a modern, conventional operating room by 20 ± SD 50 minutes (equating a moderate Cohen's effect size of 0.4 = 20/50).
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Ethics approval
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Institutional Review Board of the Charité University Medical Center. Date of approval: 06/02/2008 (ref: EA1/004/08)
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Study design
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Single-centre, randomised controlled trial.
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Countries of recruitment
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Germany
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Disease/condition/study domain
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All elective orthopedic and/or trauma, or visceral surgical procedures.
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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1. Acute, emergency, or life-saving surgery
2. Refusal of trial participation
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Anticipated start date
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01/05/2008
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Anticipated end date
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01/05/2009
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Status of trial
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Ongoing
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Patient information material
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Target number of participants
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"Intent to treat" (ITT) population: 2 x 200 patients
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Interventions
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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 integrated i-Suite operating theatres.
Control intervention:
A similar range of procedures, conducted in a conventional, last-generation operating theatre.
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Primary outcome measure(s)
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Time interval from the patient's entry to discharge from the operating theatre.
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Secondary outcome measure(s)
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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)
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Sources of funding
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1. Unfallkrankenhaus Berlin Trauma Center (main funding body) (Germany)
2. Additional funding will be sought from Stryker (Germany)
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Trial website
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Publications
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Contact name
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Prof
Axel
Ekkernkamp
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Address
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Department of Orthopaedic and Trauma Surgery
Unfallkrankenhaus Berlin
Warener Str. 7
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City/town
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Berlin
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Zip/Postcode
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12683
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Country
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Germany
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Email
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axel.ekkernkamp@ukb.de
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Sponsor
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Unfallkrankenhaus Berlin Trauma Center (Germany)
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Address
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Warener Str. 7
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City/town
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Berlin
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Zip/Postcode
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12683
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Country
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Germany
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Email
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dirk.stengel@ukb.de
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Sponsor website:
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http://www.ukb.de
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Date applied
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31/03/2008
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Last edited
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11/04/2008
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Date ISRCTN assigned
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11/04/2008
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