Condition category
Surgery
Date applied
31/03/2008
Date assigned
11/04/2008
Last edited
11/04/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Axel Ekkernkamp

ORCID ID

Contact details

Department of Orthopaedic and Trauma Surgery
Unfallkrankenhaus Berlin
Warener Str. 7
Berlin
12683
Germany
axel.ekkernkamp@ukb.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ukb_6.1_2008

Study information

Scientific title

Acronym

ENTERPRISE

Study hypothesis

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

Institutional Review Board of the Charité University Medical Center. Date of approval: 06/02/2008 (ref: EA1/004/08)

Study design

Single-centre, randomised controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/05/2008

Overall trial end date

01/05/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

"Intent to treat" (ITT) population: 2 x 200 patients

Participant exclusion criteria

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

Recruitment start date

01/05/2008

Recruitment end date

01/05/2009

Locations

Countries of recruitment

Germany

Trial participating centre

Department of Orthopaedic and Trauma Surgery
Berlin
12683
Germany

Sponsor information

Organisation

Unfallkrankenhaus Berlin Trauma Center (Germany)

Sponsor details

Warener Str. 7
Berlin
12683
Germany
dirk.stengel@ukb.de

Sponsor type

Hospital/treatment centre

Website

http://www.ukb.de

Funders

Funder type

Hospital/treatment centre

Funder name

Unfallkrankenhaus Berlin Trauma Center (main funding body) (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Additional funding will be sought from Stryker (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes