Study of Fast-track Surgery in Hernia Repair and Laparoscopic Cholecystectomy

June 11, 2013 updated by: University of Aarhus

Consequences of Fast-track Training in Surgery in Denmark in Selected Operative Skills.

All Danish trainees in surgery in a two-year period asked for participation when enrolled in the formal five-year training program for specialty in surgery. The participants are randomized for either educational intervention or control (without intervention). The intervention group receive a skills-lab course in hernia repair followed by an opportunity to perform 20 groin hernia repairs in their departments within 4-8 weeks. Their performance will be video recorded three times during the intervention and as follow-up at end of the first year of training. After termination of the hernia training program a similar program for laparoscopic cholecystectomies are made. Each participant receive both intervention. The control group are video recorded at start of their first year and at end. All videos are blindly assessed with a validated rating scale of operative performance. The purpose is to assess if a fast-track program improves technical skills and if a change is sustained. Furthermore we want to compare outcome in similar training programs in open and laparoscopic skills.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Centre of Medical Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Medical doctors accepted for formal surgical training in Denmark in 2010-11.

Exclusion Criteria:

  • Current experience in surgery exceeding need of supervision in groin hernia and cholecystectomy procedures.
  • Employed at a non-participating hospital.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fast-track training
A skills-lap course (1 day) followed by opportunity to perform 20 planned surgical procedures of each type (open groin hernia repair and laparoscopic cholecystectomy) under supervision and within 4-8 weeks. Videorecording at start, mid and end and at follow-up before ending first year of training.
Other: Fast-track training
No Intervention: Control
Follows the existing training program without intervention. Video recording of the trainee performing a open groin hernia repair and a laparoscopic cholecystectomy procedure at start end end of first training year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Technical skills in performed surgical procedures
Time Frame: Three years
Blinded video recordings of the trainees' performances are rated with a validated rating scale of technical skills.
Three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: Three years
The time in performing the surgical procedures are recorded.
Three years
Satisfaction
Time Frame: Three years
The intervention group participants are asked for their experience and satisfaction with a fast-track program
Three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Central Denmark Region
Aalborg University Hospital
TRYG Foundation

Investigators

  • Study Chair: Peder Charles, MD, DMSci, University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

June 11, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

June 14, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MEDU001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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