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

Sponsor
University of Aarhus (Other)
Overall Status
Completed
CT.gov ID
NCT01877824
Collaborator
Central Denmark Region (Other), Aalborg University Hospital (Other), TRYG Foundation (Other)
35
1
2
36
1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Fast-track training
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Official Title:
Consequences of Fast-track Training in Surgery in Denmark in Selected Operative Skills.
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Mar 1, 2013
Actual Study Completion Date :
Mar 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Technical skills in performed surgical procedures [Three years]

    Blinded video recordings of the trainees' performances are rated with a validated rating scale of technical skills.

Secondary Outcome Measures

  1. Operative time [Three years]

    The time in performing the surgical procedures are recorded.

  2. Satisfaction [Three years]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre of Medical Education Aarhus Denmark 8200

Sponsors and Collaborators

  • University of Aarhus
  • Central Denmark Region
  • Aalborg University Hospital
  • TRYG Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01877824
Other Study ID Numbers:
  • MEDU001
First Posted:
Jun 14, 2013
Last Update Posted:
Jun 14, 2013
Last Verified:
Jun 1, 2013
Keywords provided by University of Aarhus

Study Results

No Results Posted as of Jun 14, 2013