NCT00591435

Brief Summary

Anaesthesia and surgery related time intervals of three standard operations are compared depending on whether residents or consultants are performing anaesthesia and surgery. Hypothesis: Perioperative workflow is influenced by state of education, time intervals reflecting anaesthesia as well as surgical performance increase due to resident training. Therefore, costs of perioperative care increase as well.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
Last Updated

March 24, 2010

Status Verified

November 1, 2007

Enrollment Period

11 months

First QC Date

December 28, 2007

Last Update Submit

March 23, 2010

Conditions

Keywords

AnesthesiaSurgeryEducationEconomics

Outcome Measures

Primary Outcomes (1)

  • Anaesthesia and procedural related time intervals

    All events will be recorded intraoperativly

Secondary Outcomes (1)

  • OR costs are calculated as $ 15.00 per minute, additional costs due to increase of time intervals will be analyzed

    All data will be recorded intraoperaitvly

Study Arms (3)

1

200 laparoscopic cholecystectomies will be included, consultant cases will be compared to resident cases

Other: Comparison of performance of consultants versus residents

2

200 laparoscopic pelviscopies will be included, consultant cases will be compared to resident cases

Other: Comparison of performance of consultants versus residents

3

200 transurethral resection of urinary bladder or prostate gland will be included, consultant cases will be compared to resident cases

Other: Comparison of performance of consultants versus residents

Interventions

Anesthesia as well as surgical workflow will be analysed. Performance of consultants will be compared to residents

123

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy subjects scheduled for one of the three defined procedures (defined by German Diagnose Related Groups ID) under general or regional anesthesia

You may qualify if:

  • Healthy subjects scheduled for one of the three defined procedures (defined by German Diagnose Related Groups ID) under general or regional anesthesia

You may not qualify if:

  • Patient's refusal of data collection, emergency procedures, change of physician in charge (resident to consultant or the other way around) of anesthesia or surgical team

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

Location

Study Officials

  • Jens Scholz, MD, Professor

    Department of Anaesthesiology and Intenisve Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2007

First Posted

January 11, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 24, 2010

Record last verified: 2007-11

Locations