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Completed

NCT Number: NCT01877824

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

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.

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Key information

Conditions

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre of Medical Education

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fast-track training

Other

Primary outcomes

  1. 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.

Secondary outcomes

  1. Operative time

    Time frame: Three years

    The time in performing the surgical procedures are recorded.

  2. Satisfaction

    Time frame: Three years

    The intervention group participants are asked for their experience and satisfaction with a fast-track program

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Aalborg University Hospital
  • Central Denmark Region
  • TRYG Foundation

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 14, 2013
Registry last updated
Jun 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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