Effectiveness, neuropsychological distress, teamwork, and ergonomics with procedures conducted in the i-Suite surgical environment
| ISRCTN | ISRCTN94152783 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN94152783 |
| Secondary identifying numbers | ukb_6.1_2008 |
- Submission date
- 31/03/2008
- Registration date
- 11/04/2008
- Last edited
- 11/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Axel Ekkernkamp
Scientific
Scientific
Department of Orthopaedic and Trauma Surgery
Unfallkrankenhaus Berlin
Warener Str. 7
Berlin
12683
Germany
| axel.ekkernkamp@ukb.de |
Study information
| Study design | Single-centre, randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | ENTERPRISE |
| Study objectives | 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). |
| Ethics approval(s) | Institutional Review Board of the Charité University Medical Center. Date of approval: 06/02/2008 (ref: EA1/004/08) |
| Health condition(s) or problem(s) studied | All elective orthopedic and/or trauma, or visceral surgical procedures. |
| Intervention | 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. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Time interval from the patient's entry to discharge from the operating theatre. |
| Secondary outcome measures | 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) |
| Overall study start date | 01/05/2008 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target number of participants | "Intent to treat" (ITT) population: 2 x 200 patients |
| Key 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 |
| Key exclusion criteria | 1. Acute, emergency, or life-saving surgery 2. Refusal of trial participation |
| Date of first enrolment | 01/05/2008 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Orthopaedic and Trauma Surgery
Berlin
12683
Germany
12683
Germany
Sponsor information
Unfallkrankenhaus Berlin Trauma Center (Germany)
Hospital/treatment centre
Hospital/treatment centre
Warener Str. 7
Berlin
12683
Germany
| dirk.stengel@ukb.de | |
| Website | http://www.ukb.de |
"ROR" |
https://ror.org/011zjcv36 |
Funders
Funder type
Hospital/treatment centre
Unfallkrankenhaus Berlin Trauma Center (main funding body) (Germany)
No information available
Additional funding will be sought from Stryker (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
